Tylenol No Longer Deemed a Pain Reliever for Babies and Toddlers

Tylenol No Longer Deemed a Pain Reliever for Babies and Toddlers
Tylenol for Babies & Toddlers?!? 

The FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee have together recommended that “pain relief” be removed from the label of Tylenol and other brands of acetaminophen because there is no reliable evidence that it relieves pain better than placebo in children under age two.

This will surprise many parents who reach for these common pain relief drops when their little ones are teething or have an earache or a sore throat. Not surprisingly, the over-the-counter drug industry trade group (CHPA) objects to the findings of the expert panel.

Tylenol Does Reduce Fever – But Why?

The advisory panel recommended that the acetaminophen label should say it’s for “fever reduction” and nothing else. But here’s the thing – in most cases the fever is helping the child by activating the immune system and fighting the infection. I don’t routinely recommend treating a typical fever unless it is interfering with a child’s ability to sleep or to drink liquids (both are even more important for healing than the fever). If the fever is high or prolonged, it is wise to consult with a physician.

If we don’t give acetaminophen to babies and toddlers for pain, and we rarely give it for fever – this will change the landscape of over-the-counter medications for young children.

Tylenol Is Not As Benign As Many People Think

Acetaminophen is the most common cause of acute liver failure in the US. It has been estimated to cause three times as many cases of liver failure as all other drugs combined. While the serious problems usually come from overdoses, in babies and small children the dose that can cause harm may be not many times more than the recommended dose.

Tylenol Dosing Should Be Based on Weight

Most dosage charts that parents see list a dose based on age, or suggest that parents ask a doctor for the dose. And dosage concentrations have varied in various formulations. Together, this confusion has led to overdosing and to fatalities in several dozen healthy young children over the last decade.

The FDA panel has recommended that all liquid acetaminophen come in the same concentration, that all packages contain dosing information for children down to 6 months of age, and that the dose be based on the child’s weight.

Powerful Recommendations

I applaud these recommendations and hope they will be formally adopted by the FDA. If so, I expect they will result in safer children. As parents we don’t have to wait, though, to change our own practices.

Resources:

FDA Advisory Committee Meeting Minutes

FDA Meeting Transcript: Day One

FDA Meeting Transcript: Day Two

OTC Industry Supports FDA Advisory Committee Recommendations on New Dosing Instructions May 18, 2011.

Lee WM. “Drug-Induced Hepatotoxicity.” New England Journal of Medicine, July 31, 2003, 349:474-485

We’ve known much of this for over a decade:

PERSONAL HEALTH; With Tylenol and Children, Overdosing Is Perilously Easy

Dr. Alan Greene

Dr. Greene is the founder of DrGreene.com (cited by the AMA as “the pioneer physician Web site”), a practicing pediatrician, father of four, & author of Raising Baby Green & Feeding Baby Green. He appears frequently in the media including such venues as the The New York Times, the TODAY Show, Good Morning America, & the Dr. Oz Show.

  1. Mel

    i both agree and disagree with this article. My 6yo son has some pretty severe disabilities. We’ve had both encounters of medical staff at hospitals overdosing my kiddo to the point of septic renal failure, and when Tylenol is used correctly, it’s saved his life ample times from preventing febrile seizures from temp spikes ( staggered advil and Tylenol) I don’t find Tylenol to be as affective as advil for pain, BUT!! There are certain components in Tylenol that cannot be given to all kids based on medical Dx’s, just as well as other meds… This is a hit and miss article in my eyes, but as a mother living through a nightmare caused by “too much” of an admin I do understand

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  2. Teri Woodrum

    I have to say also I dont agree ..Tylenol was a factor in rrducing fever and pain in my children growing up and it worked it still works and you need not change it ..wat are u all tryin to do ? This is ridiculous to me adds to the list of Governmental population control..Im frankly pissed you change something that works to this day..makes one wonder what the hell is goin on

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  3. Pam

    How exactly is an infant suppose to tell you that the medication is relieving their pain if their physical response isn’t good enough? I have 3 kids and I have witnessed all 3 start to feel better after taking Tylenol especially when they have fevers. All this “scientific evidence” is getting out of hand. Everyday “Science” claims we are doing something wrong yet the majority of kids are healthy and your article didn’t mention which illness were studied while tylenol was being given. So many issues with these studies. I plan to continue to give my children Tylenol and I am sure their pediatrician would tell me not to take advice from the internet.

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  4. Nathaniel

    It would seem tragic to me to waste millions of dollars to spend money on clinical research studies investigating whether or not oral acetaminophen is effective for the population less than 2 years old. If we conclude that intravenous acetaminophen is effective, and believe that oral acetaminophen is absorbed into the bloodstream (which we can infer from its impact on fever reduction), then it would logically follow that oral acetaminophen was be effective for this patient population. As the FDA panel suggests, there is a lack of high quality studies in this patient category, but lack of evidence of benefit does not mean evidence for lack of benefit. The FDA seems to have made a responsible decision to leave pain relief on the label (in my opinion). We have a limited amount of research funds in this country, and I sincerely hope that we choose to fund more worthy clinical questions than the one you raised with your blog post. I hope parents continue to give acetaminophen, especially in neonates and infants, as it is most likely safer than an alternative medication (ibuprofen) or not medicating at all.

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    • Thanks for your well-reasoned comment! The thing about kids less than two years old is that it’s a pivotal time of development – to the extent that there is an important emerging area of science called the Developmental Origins of Health and Disease (DOHaD). A combination of maternal and environmental factors early in life can have a longterm effect on health. Because acetaminophen is one of the most widely used medications at that age, because we know acetaminophen is a powerful drug, and because we know so little about the effects at that age (having not even shown pain relief), to me it seems an important area for research – or at least not to cover over the questions.

      Which questions to study and how to study them is a great discussion to have – and thank you so much for raising it!

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  5. Kristina

    I usually love your blog, but I’m not in love with this article.

    My son basically had an ear infection for the first two years of his life. I regularly gave Tylenol, the dye-free variety more often than not, and I can tell you with absolute certainty that it relieved his pain. I routinely witnessed a transition from cranky and inconsolable to calmer and more relaxed after administering. I’m a nurse, so I also pay attention to things like respirations and heart rates, and those too were reduced.

    My biggest issue with this article, however, is this statement: “I don’t recommend treating fever unless it is interfering with a child’s ability to sleep or to drink liquids (both are even more important for healing than the fever).” This is fine if you’re referring to a low grade fever, but you don’t specify that. Fevers that get too high and last too long cause protein denaturation and thus organ damage (namely brain damage). No one should be replacing their physicians advice with information gleamed from a blog, but that doesn’t change the fact that people listen to you.

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    • Kristina, thanks for your comment!

      The experience of a nurse and a mother is valuable indeed. Your routine experience is compelling. I still think it’s sad that when it comes to commonly used medicines in infants and toddlers that the effects have often not been well-studied. Wouldn’t it be great if your experience of clinical observation and of changes in vital signs – and the experience of thousands of other nurses – were collected and explored, since the medicine is being given anyway. We could learn so much about the timing of effect, for instance, which might be very different in babies than in older kids.

      I’ll edit the article to incorporate your suggestion of being specific that I’m not talking here about very high fevers. Thanks again!

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  6. D

    This studies are dumb and I am sick of all this. We have been given Tylenol to my 8 month old and it works for him. It helps his mouth and with the discomfort he gets with having fluid build up in his ear. All this crap does is try to make parents question all they do and stuff. I will continue giving my kids this because it does work. You cannot believe everything you read. But I do trust my kids doctor because he is more knowledgeable then Google.

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    • Me

      I agree whole heartedly. I wish I could like that multiple times. I worked wonders for ear aches here. But, I as far as the Google thing. I’m glad you have a smart doctor. Mine has went all “organic” and refuses to give dosing information for Tylenol under age 4 without seeing them. He gets $80 for each visit and I get a dose amount (not to count time off work). And, ibuprofen hurts one of my kid’s stomach (ulcer). So I have to “Google” dosage for Tylenol. Leave the darn dosing labels on the bottle. And leave the “pain reliever” on it too. If it doesn’t work for one kid doesn’t mean it won’t work for the other.

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  7. angela

    My son is almost 2 years old. Now that I think about it Tylenol did not work for my son. When he was 6 months old he had sudden fever during a day, so I called my doctor. He says give Tylenol every 4 hours. I gave it to him, still was having fever all day and evening until my doctor told me to add Motrin to it. So Motrin every 6 hour tylenol every 4 hours at the end he started vomiting. Fever still high 101. I don’t believe tylenol works. He only ended up vomiting 4 times and the fever stopped after midnight. Ever since we sticking with Motrin. So its different on every baby I guess, but thank you for the information.

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    • jojo

      you could have just put your baby in a temped bath so the fever would break.

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      • alysia

        You’re actually not supposed to put your children in a Luke warm or cold bath/shower when they have a fever. Ur drops the body temperature way too fast and can cause the child to go into shock. You should apply cold compresses under the armputs and on the groin area. ~Someone with experience in the nursing field

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    • Momma

      You did read the article right?? Where it says that Tylenol does reduce fever. They may be wrongly stating it doesn’t work for pain but as for fever… it does yours may have been expired. And Tylenol isn’t acually a pain reliever. Anyone who works in the medical field will tell you that Tylenol acually works in a unique way unlike most medications. It does NOT relieve pain but acually increases a persons pain tolerance. And a fever is NOT good for a child or anyone. Yes it is a sign that your body is fighting off an infection but the fever itself is not good for you.

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    • toni

      Tylenol never worked for my son either he is 18 months old and the only thing that worked for him was motrin (ibprofen)

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  8. Miranda

    When my medically complex son was teething we would administer Tylenol. He was always on a Pulse Ox so we could monitor his O2 sats and heart rate. He would always have an above average heart rate while teething, usually in the 160’s. Then after getting Tylenol it would drop. I feel like this is significant evidence that Tylenol was reducing his pain.

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    • Miranda – that’s nice evidence indeed. And I like the way you think!

      With medical-grade sensors becoming far less expensive and far more available, I’m looking forward to parents being able to get better answers to lots of questions. One person doing this is powerful (and can answer the question for your particular child). With lots of us doing it we could learn so much so quickly!

      When ResearchKit was released by Apple two weeks ago, it was able to do in only 24 hours what would typically take 50 medical centers a year to do – recruit 10,000 people into a medical study.

      These FDA Advisory Committees had all the available medical literature available to them in trying to answer their question – but there was very little data, gathered over many years, involving very few children, with mediocre results at best – so they had little choice but to say there’s not enough evidence to conclude that acetaminophen relieves pain in kids 6 month to 2 years.

      If 10,000 parents did what you did, we could know in a day.

      The next question would be, if it works, is it the acetaminophen in Tylenol (the ‘active ingredient’) or is it another ingredient (such as the high fructose corn syrup) or a combination of the ingredients.

      FYI: The ‘inactive’ ingredients in Cherry-Flavored Infant’s Tylenol include: anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, and xanthan gum.

      Various types of ‘sugar water’ have been shown to significantly relieve pain in babies. Also, there are large studies showing that coal-based FD&C dyes can affect behavior. The sorbitol and sucralose might play a role. There’d still a lot to sort out – but we could do it.

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      • Miranda

        Thank you for responding so quickly. Just wanted to add that we always used the dye-free tylenol (usually generic). I just looked up the ingredients and it has no high fructose corn syrup. My son has a g-tube so dye-free was better for us. Also, there are thousands children/babies out there hooked up to pulse ox probs just like my son. And many of them have home care nursing that document well. There is no reason that this information couldn’t be used to aquire data.

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        • Kath

          Miranda, I’m with you. I don’t agree with this article AT ALL (sorry Dr. Greene). If Tylenol works for children & adults, then why wouldn’t baby Tylenol with the same active ingredient work for babies/infants? We have used dye free and Tylenol brand, BOTH seem to help my baby with teething pain and sleep better. We don’t give it often, but when we do it’s because nothing else works. Even though my testimony isn’t data or “reliable evidence”, it shouldn’t discredit that Tylenol (or other brands) works.

          This article was written prematurely in my opinion. Until there is substantial research done & data collected, I don’t think this recommendation should be taken seriously.

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          • Great points, Kath! Usually medicines that work for older children and adults do work for younger children and babies – and vice versa. But not always.

            The question of whether they could just extrapolate from what we know from older kids and adults was discussed at length in those meetings. They pointed out that in the 375 or so cases where they had formed opinions based on extrapolation, they ended up changing their mind 20 percent of the time when they got more data to fill in the blanks. That would be more than 70 drugs that did NOT work as expected from other age groups.

            In the latest 2014 reviews of pain relief in babies, we are still relying on extrapolation for many uses of oral acetaminophen.

            My preference is for parents to understand a general idea of what we know and what we don’t: We do know it relieves pain in adults and older kids. We do know that IV acetaminophen can work even in newborns and even for surgical pain. But the studies for pain relief in babies from oral acetaminophen have been far more disappointing than I think most parents would guess – though not conclusive either way.

            I don’t object to parents trying it.

            Like you, I’ve seen very happy babies when given for teething. I think there are more effective choices for ear pain.

            Whether pain relief is on the label or not wouldn’t affect whether parents could give it – it would just prevent companies from over-promising unproven benefits.

            Our goal is the same – keeping kids as happy and healthy as possible (and parents as rested and healthy as we can!).

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        • Christy

          Miranda,
          I have to agree with you every time I took my daughter in to get shots I give her Tylonal the one time I didn’t give her Tylonal she was up all night in so much pain I had to finally go to a 24 hour wallgreens and get her some Tylonal and within 30 min of her taking it she calmed down and went to sleep

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        • Miranda, that would be exciting!

          The wonderful Linda Avey, who was the co-founder of 23andMe, the world’s first personal genetics company, is now working working on a cool new project called We Are Curious (www.wearecurio.us) – a platform that will soon help people agree on questions and put them to the test.

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      • Leigh Ann

        Interesting that you mention about the high fructose corn syrup. When my brother was a baby in the 70s we had a neighbor with teenagers who swore by red sucker for teething. I remember my mom rubbing that sucker on my brother’s gums and him calming down. I mentioned it to my daughter’s pediatrician in the early 2000s and she said “it’s probably the sugar”. We used Hyland’s teething tablets and had great results with that so I never bothered with sucker. But the doctor didn’t dismiss it as implausible or just an old wive’s tale.

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  9. Nicole Henderson

    Has anyone noticed that this article was published in 2011 and you can still purchase infant strength Tylenol with “pain-reliever” on the label? Something about this article isn’t right or something has changed after its posting. I see that this is making the rounds right now but wonder how many people are noticing the year it was published. Also, I could find no other articles from sources like the FDA talking about this issue.

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    • Hi Nicole. Thanks. As you point out this joint meeting of the FDA Advisory Committee for Nonprescription Drugs and the the FDA Pediatric Advisory Committee took place on May 17th and 18th 2011. I wrote this article later on May 18th. The dozen or so manufacturers of acetaminophen were unable to point to evidence that convinced the doctors, nurses, pharmacists, and patient advocates present that oral, OTC-strength acetaminophen relieves pain in children 6 months to 2 years old. The experts reviewed all 10 studies that addressed this question and concluded there was no compelling evidence for pain relief (unlike fever reduction, which is clear cut). They often used the word analgesia, which is a medical word for pain relief.

      You can read the whole FDA transcript here on the FDA site: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264149.pdf

      It appears to have been a spirited discussion. At the hearing, the Director of Pain Medicine at Seattle Children’s Hospital said, for example, “it would be a horrendous disservice to young children to label this product as having any kind of analgesic effects because I think that if we assume that it does, and people are walking around giving acetaminophen to children thinking it’s analgesic and it’s not, you’re going to have a lot of children stuffing pain that should not be.”

      “So I would argue extremely strongly that unless there are data to convince us that this product is analgesic in young children, that that should not only not be on the label but should be made extremely clear to the public and professionals alike that the analgesic effects of acetaminophen in younger children have not been shown.” (page 106)

      But despite their strong decision, it was never made extremely clear to the public or to professionals that pain relief for younger children had not been shown. (Though this little post has certainly been passed around recently!)

      Unsurprisingly, the manufacturers were not pleased with the decision of the advisory groups and wasted no time in speaking up. They also voluntarily agreed to change the concentrations on their new labels to make them consistent, instead of different concentrations for different ages, to reduce overdose (a major problem). When the FDA made it’s decision on the new labels, they chose to disregard the recommendations of their advisory groups about pain relief. This is not unusual. They weigh many issues in their larger deliberations, not just the findings of the physicians, nurses, pain specialists, pharmacists, and patient advocates.

      Where does that leave us today?

      Pain relief on the label is unchanged for children under 2.

      The latest major scientific reviews of pain medications in infants I can find today were published in 2014. We are perhaps better now at measuring pain in babies, using validated combinations of heart rate, oxygen levels, blood pressure, as well as facial expressions, cries, and sometimes hormone levels.

      We do know and have known that oral acetaminophen relieves pain in older children and adults. And that IV acetaminophen works for babies and toddlers. But the studies looking for pain relief from oral acetaminophen in babies have been disappointing. (For instance, in babies getting a heel prick, there was no discernible difference between babies who got or didn’t get oral acetaminophen). But heel prick pain is different than teething pain, which is different than an earache.

      I’m not saying it doesn’t work – I’m saying we don’t know enough. And we should. Babies’ pain is important.

      Thanks again, Nicole.

      1) Pain management in newborns. Clinics in perinatology. yr:2014 vol:41 iss:4 pg:895
      2) Neonatal pain. Paediatric anaesthesia. yr:2014 vol:24 iss:1 pg:39

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  10. Leonard

    My family & friends use dōTERRA essential oils with great success.

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    • Allison

      Leonard, What combination of oils do you use to reduce fevers in toddlers and infants? AND how do you use them…topically? Orally?

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  11. rob

    I would disagree your with this Tylenol is like the suger pill method Working with your state of mind making you think it dose all those things but yet i it dosnt its proven your state of mind controls your pain and your feeling if i would walk on a plane and say their is someone among you that is carrying a virus and lest the symptoms Like you would gave a upset stumck pain in your hand your feet are sore. But of course your going to think that its you becuse of your state of mind. All Tylenol is a a trick its acting with your state of mind making you think it helps you but in retrospect it doesn’t really do anything for you.

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  12. Sara galindo

    What do you recommend for a pain reliever then? I always reach for the infant Tylenol for my daughter.

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  13. Jayme

    I have no choice but to give my daughter who is 3 years old…because she has seizures from fevers she has even had a seizure with a very low grade fever and just recently had another seizure with a fever about a week ago….shes been having these since she was 9 months old.

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    • Acetaminophen is effective at reducing fevers at every age – and can be a good choice when reducing fevers is wise. When reviewing all available studies, the FDA Advisory Committees couldn’t find adequate evidence to say that acetaminophen reduced pain in kids 6 months to 2 years old.

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    • Shelly

      My oldest had febrile seizures as well. We still keep tylenol and motrin stocked in our medicine cabinet.

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    • rose

      I feel your pain Jayme. I have two kids who go through the same thing. My older boy is now growing out of it. He has had three fevers with no seizure. We did a lot of things other then just meds. We would put peppermint on the back of their neck and on their feet, give then cool baths, put fever cool packs on the back of their necks, popcicles, and lots of love. There was one time we gave 8 baths in one day to keep the fever low. Its super scary and I’m sorry you have to go through that.

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    • Richard Feuille

      Fortunately, febrile seizures, while frighteing, are not harmful. Efforts to reduce fever DO NOT prevent febrile seizures. The height of the fever, as you have seen has little to do with having a seizure. This has been very well studied and neither tylenol, ibuprofen, tepid baths nor any combination of these does not work to prevent these seizures. And, temperatures have to be well over 107F to cause any brain injury. My children always had 105F when they were sick and had no seizures or brain damage. I did not give them anything for it. So, giving anything to prevent these only impedes the body’s immune system from fighting the illness. And, there is evidence that tylenol promotes the development of asthma and makes it worse if one has it. More recent studies suggest that tylenol contributes to heart disease as well. So, I give advil or tylenol only for relief of discomfort. I prefer advil.

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    • jess

      I hope she’s being treated with other medication fir the seizures. My niece started with seizures at around 2 by high fever so she had to have it under control but she was also prescribed medication for the seizures. It was really important because that prevented the seizures to become permanent. She had to take that medication until she was 5 to prevent permanent seizures. Now she’s12 and healthy

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      • Richard Feuille

        Only 2% of kids with febrile seizures develop epilepsy. Unless they are unusual or complex, they are not treated with antiseizure medications. FWIW, 1% of the general population develops epilepsy.

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  14. Jane

    Wow guys really?? Stop drugging your babies. They do not need Tylenol or Motrin or ibuprofen. Your damaging their neurological pathways and damaging their stomachs, livers, brains, ect….take a little time to do some research on natural remedies. You probably have them in your refridgerator. Hugs and cuddles work wonders with helping ease the pain. Fevers help fight infection. Not trying to judge but as a society we are way to programmed to just pop a pill to fix it. You should google the bad batches of children’s Tylenol that resulted in death. It’s just not worth the risk. Tylenol sure as heck doesn’t cure anything.

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    • JJ

      Next time you are in pain for whatever reason be sure to ask your Dr. for “hugs and snuggles” because that works for me….not!

      How do we know Tylenol doesn’t work for pain? You are talking about an age group that can’t speak for themselves. Tylenol helps me. It helps older children. ..why not toddlers and babies?!

      Obviously, medicine should be the last option, but it IS an option.

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      • Kath

        I totally agree, JJ. My argument exactly!

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    • lynn

      And kids can have brain damage if their fever hits 105 or more… So what do u do then cause not all home remedies work. And usually most parents don’t have home remedies onhand. And surely I would be googling home remedies while my child has a ripping fever seriously. Don’t believe u should give ur child med over every little thing buy temperature are not something to mess with.

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      • Richard Feuille

        It takes temperatures above 107, if not higher to cause any brain injury. This only happens in a child with a significant themperature control problem. My kids didn’t have fevers that weren’t 105F. I didn’t give them anything. The myth that fever causes brain injury just won’t die. As Dr. Serwint of Johns Hopkins says, ‘Fever is a part of the body’s well orchestrated response to infection.’

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    • Adrienne

      As a medical professional, I too choose to limit the amount of medications I give myself and my children, as fever to certain point is actually beneficial in helping the body eliminate infection. However, it’s time to get off your soap box. Instead of shaming parents for the way they raise their children, it would be helpful to offer data from reputable research that both proves the risks of common medicines like acetaminophen, as well as efficacy of naturopathic remedies. “Wow, guys really??? Stop drugging your babies.” is not helping your case, and will certainly lead to your advice falling on deaf ears. Not trying to judge but as a society we are way to (sic) programmed to see ourselves as “holier than thou,” and criticize others behind our computer screen. <—–see what I did there?

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    • Laura

      Do hugs and cuddles help with the pain from a broken bone or sore throat? Motrin is ibuprofen.

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    • Rebecca

      Judgement much? If tylenol reduces my child’s fever so that she can sleep comfortably, then it’s worth it, sleep is important when fighting a bug. It’s a tool in the tool box to help the child through illness, but not the only tool.

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      • Richard Feuille

        It is not the fever that causes the discomfort, it is the illness. The hottest kids on the planet have Roseola. They are typically 104-105+, yet they aren’t all that uncomfortable. The child feels better when you give them a pain reliever, regardless of whether the fever drops.

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        • Elle

          When you don’t treat a high fever kids stay sicker, longer. They get weak, won’t eat or drink, and end up in longer recovery time. Treat the fever, rest better, eat better, drink fluids equals getting well faster. I have seen this time and time again with my 3 children.

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    • Richard Feuille

      While not my favorite drug for much of anything, there are no bad batches of Tylenol. People are taking or giving the wrong doses. It should always be dosed by weight. For example, 2×500 mg Tylenol is an overdose for many small adults, especially many women. The max dose for regular use is 15mg per kilo. And, many medications contain it, so if taking several multi-symptom medications for a cold or the flu plus any acetaminophen, which have many names, one is getting an overdose. I agree that fever is generally a good thing and one should not be in the business of reducing it, except in a few cases such as heart failure or lung failure when the extra oxygen required for the fever can make the heart or lung disease worse.

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    • jess

      I totally agree with you

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    • Lars

      Humans have been consuming acetylsalicylic acid from willow bark for pain relief for thousands of years. Try reading something other than the internet.

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      • Richard Feuille

        While true, acetyl salicylic acid (aspirin) can cause Reye’s disease. We don’t see this devastating illness much anymore since the use of aspirin was greatly curtailed in the early 80’s.

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  15. j

    You should always take articles like this with a grain of salt something like this should always be discussed with your pediatrician every child is different. As for this article I don’t trust any study where they don’t even double check their work in the first sentence it says nonsprescription where it should say nonprescription, if you can’t even use spell check how can I rely on your study.

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    • linda

      Go to the drug store and get some teething tablets. I used them for my 5 yr old and we use them for my 17 mo old grandson. They are herbal.

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      • Laura

        They are not FDA approved so if we are going by that then they shouldn’t be recommended.

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      • megan

        Look up what teething tablets has caused they was post to recall them

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    • Marianne

      I was told about this several years ago by my pharmacist so it is known. There is a lot of negative information about acetaminophen. She also mentioned never under any circumstances take it when it has expired. It starts to break down and can be toxic. Whenever I hear someone say they are using this drug, I mention all I have been told so they are at least more aware.

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    • Thanks, j, for your comment. I agree that every child is unique and that this is wise to discuss with your pediatrician. This article isn’t about a single study – I was just reporting that when the FDA convened a panel of top physicians, nurses, pharmacists and patient advocates to look at all the studies on acetaminophen as a pain reliever for kids under 2, they concluded that there was not enough evidence to say it does relieve their pain. And the manufacturers were not able to produce additional evidence.

      This doesn’t mean it works or doesn’t work, just that we should take claims that it works with a grain of salt.

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      • Jay

        Where does it say anywhere in those minutes that the panel suggests pain relief be removed from the label of Tylenol? Where in the minutes does it mention that there was not enough evidence to support the efficacy of Tylenol for pain management in children? It isn’t even addressed in the panel minutes that you cited. Why fabricate something and then provide a link that does nothing to back up your fabrication?

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        • Jay, thanks for getting back.

          Their decision after weighing the evidence for how well it works in kids 6 months to 2 years old came late on the second day of the meeting, so it shows up on page 6 of the minutes. It’s easy to miss, in part, because they use the word ‘analgesia’ for pain relief.

          First they concluded that acetaminophen IS effective for reducing fevers at that age. Then (quoting from the minutes) “However, the majority of the committees agreed that new labeling should not include an analgesic claim because there is no substantial/conclusive evidence that acetaminophen is efficacious in relieving pain in children 6 months to 2 years of age.”

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      • Laura

        Pain is subjective. To be able to ask a child of those ages what is their pain level is not doable. That’s why we use the FLACC scale. We also know that acetaminophen relieves pain in adults, so it would be easy to assume that it would also relieve pain in small children. Also, this meeting was from 2011 and I have not seen any change in labeling.

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  16. Karri

    My youngest will be 14 months in 5 day’s and he is teething something horrible right now. 3 teeth are coming in at once I normally give him Tylenol when his fever gets to the 100 mark and have always done the dosage by his weight but have noticed it doesn’t do much for his pain. What can I safety give him for pain the last 3 nights have been very sleepless for him and me. What should I try for effective safe pain relief for him?

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    • am

      I have to rub orejel night time formula on mines gums espessaily at night before he falls asleep otherwise hes very wrestless

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      • Richard Feuille

        Oragel has benzocaine, which can cause methemoglobinemia (chocolate blood). If you use this, use the smallest possible amount, if any at all.

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    • Erinn

      I just got an amber teething necklace for my 3 month old (yes! he IS already teething!!! AGH!) the brand I got is Healing Amber.

      They don’t even have to chew it to feel relief!

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      • Jen

        The amber is never meant to go in their mouths. It works from being against their skin.

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    • Lee-Ann

      I’m no doctor, but after having 2 kids, now 7 and 3 yrs, I have found that rubbing some childrens benadryl liquid medicine on their gums using your finger has helped releive a lot of the pain. Hope this helps!

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    • Jen

      Try hyland’s teething tablets. An amber necklace. Nurse on demand. Breastmilk slushies or frozen fruit in a mesh feeder. So far I have never had to medicate either of my children for teething pain.

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  17. megan

    I think this is ridiculous! If Tylenol relieves adult pain which it does there is no reason to think it doesn’t work for little kids. Infact it has been used as a pain reliever in all my daughters surgeries including her open heart surgery it was given in a dose with no filer via iv but you could tell right away it helped. Will it help all kids no just like not all adults but I think to say it doesn’t relieve pain is silly. I agree all kids should be same dose and concentration. Parents need to make sure they are being accurate when dosing when in doubt call a nurse line doctor office or pharmacist to make sure.

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    • Adrian

      it says there’s no proof it’s as effective as a placebo. My thing is how do you test a placebo on a young child that can’t tell you how much pain they are in. The point of a placebo is for them to think its the Tylenol. Problem. With that is they don’t even know why you’re giving them the Tylenol, let alone a placebo. I don’t get it.

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    • Nick

      Not so ridiculous actually since I feel Tylenol provides no pain relief in adults and some more recent studies verify it provides no relief. I was reading a study on Tylenol and the effectiveness for chronic back pain relief. They did a controlled study. The results showed Tylenol provides no relief for chronic back pain. Over 90% of the people given the Tylenol vs the Placebo said that it provided no relief. So overall test results showed Tylenol is just as effective as a placebo, and the only people that said it helped there pain are the people that had the placebo effect, where they take something and is told it will help and then mentally they feel it helped relieve there pain, even though it has no actual effect on pain relief.

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    • Sylwia

      I completely agree with you. That was first thought! And- The article speaks of there’s no reliable proof that it relieves pain better than a placebo in children under two – there’s very little data on placebo effect in children let alone children under 6, and under 2 please show me.

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      • Sylwia

        And the placebo effect question was geared towards the article writer. Sorry to do that on your post Megan.

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      • Great question, Sylwia. Here the FDA asked a group of physicians, nurses, pharmacist and patient advocates to review all of the studies about whether over-the-counter strength oral acetaminophen relieves pain in kids 6 months to 2 years old. Their search of the literature found only 10 studies that addressed this question.

        Of the 10 studies, four of them compared giving the kids acetaminophen to giving them placebo. Five studies compared giving acetaminophen to giving other pain relief. And one study compared giving acetaminophen to doing nothing for the pain.

        In the four placebo-controlled studies, some of the kids did seem more comfortable after getting something, but it wasn’t different between those who got the acetaminophen and those who did not.

        The group voted that these ten studies, alone or together, were not convincing that acetaminophen relieves pain at this age. You can read summaries of each of the studies here, starting on page 71: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264148.pdf

        This group was not examining the placebo effect in kids – a fascinating question in its own right – but whether there was enough evidence to say it does give pain relief to young kids.

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    • Megan, you have a lot of hard-won experience with all of your daughter’s surgeries. I can only begin to imagine what you (and your daughter) have been through!

      It turns out, though, that when it comes to the effects and side effects of medicines – kids are not just little adults. They sometimes behave very differently. And infants sometimes react to medicines very differently from older children. Pseudoephedrine is a good example of this. It’s been shown to be somewhat effective as a decongestant in adults, but not effective in kids under 6.

      With acetaminophen, the FDA asked a panel of top physicians, nurses, pharmacists, and patient advocates to review all of the existing studies about it’s effect in pain relief in kids under 2 at outpatient oral doses. They only found 10 such studies. None showed a convincing effect.

      This doesn’t mean it works or doesn’t work in general – much less in a particular child or a particular situation. It means that we shouldn’t just trust the manufacturers that it is effective.

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  18. Inquirer

    So, if this has been discussed back in 2011, did they remove the labeling or no? Our hospital still uses Tylenol for circumcisions. And what did they base the decision on?

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  19. Brian

    Sounds to me like the anti-vaccination crowd is extending their reach to medicine for children. 2 words. Natural selection. It will be in full bloom if we go down this road and it’s one that is ugly in execution and process.

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  20. Mel

    My son only has one kidney. I have been told by every single doctor that he can only take Tylenol. No motrin or ibprofin. So now what am I supposed to give him?

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    • Jenn

      My daughter also only has 1 kidney. We also only give her tylenol. My suggestion would be to discuss his particular case with his Nephrologist at his next visit and go from that recommendation; and not this article.

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    • megan

      Just my opinion but I would bring this up with your doctor and trust them it has been proven time and time again not all studies are reliable

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    • Billie

      I would follow your doctors instruction most post like this usually have self gain behind them like some trendy self remedy or something they want you to try cause it worked for them best of luck with your son God Bess him and your family

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    • david

      hugs and cuddles

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  21. Jennifer

    That’s just great, I have been giving this to my little one for teething. She is one of those babies that wants nothing to do with cold or teething toys and runs a fever in the high 100’s. What am I supposed to do as a mother if all you people can’t seem to find a common ground for babies.

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    • kelly

      If you read this completely you would have seen that Tylenol is a “fever reducer”. So you can still give it to her. Just don’t expect it to relieve pain.

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    • Kelli

      FYI you should click on the link there at the beginning–the FDA said NOTHING in the letter about pain relief. I really think this article is bogus. I’d just talk to your pediatrician about this rather than trust the internet.

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      • They discussed a lot in this meeting. On page 6 of the link at the top of the article, the minutes of the FDA Advisory Committees, it says that the committees agree that acetaminophen is effective at reducing fever in kids under 2. It goes on to say,

        “However, the majority of the committees agreed that new labeling should not include an analgesic claim because there is no substantial/conclusive evidence that acetaminophen is efficacious in relieving pain in children 6 months to 2 years of age.”

        This does not mean it works or does not work. It means that the physicians, nurses, pharmacists and patient advocates tasked with reviewing all the supportive evidence couldn’t find adequate evidence that it works for pain relief in young children.

        I agree, Kelli, parents talking with their own pediatrician about when it is right for their child.

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  22. Rhonda

    Where can I get a Concentration/Weight/Dose Chart for Tylenol?
    I would hate to depend on my pediatrician getting back to me with this information in the middle of the night.

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    • Lisa

      You can always call a pharmacist. That’s what I did when my toddler was aged out of her dose but still quite small weight-wise. There was a big difference in the doses so they gave me a more precise dosage.

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    • micki

      My son who will be two soon has Hypoplastic Left Heart Syndrome. With two open heart surgeries and two cardiac catheterizations and his doctors always recommend Tylenol, even though his heart function and meds are hard in his liver. It’s 10 to 15 mg per kilo of weight, 15 as max. Take the 10 or 15 and multiply it by total weight in kilos. Divide that by the concentration (160) then multiply by volume (5mg) For example: 10 mg * 8 kilos = 80 / 160 = 0.5 * 5 = 2.5ml of Tylenol. Only the children’s hospital has been able to provide me with the correct calculation for dosing on weight.

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    • Thank you so much for that note. We’ve updated the link in the article.

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  23. Mom of Four

    I agreed with the fever and pain etc ie letting fever do its job until…our fourth son suffered a life threatening seizure, now we use Tylenol then belly up ibuprofen to control fever as safety…how concerned should I be with later side effects?

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    • What a frightening event that must have been! I’ve heard many parents describe watching their child have a febrile seizure as among the most terrifying moments of their lives. Thankfully, the overwhelming majority of these kids end up doing marvelously well.

      I’m not concerned with using these medications at the recommended dose by kids who need them – but am concerned with overdoses, combining mixtures containing many ingredients, and using them without thought.

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    • M. N.

      When fever spikes, you should try first to control it by removing blankets and/or clothing. Cold wash cloths to the forehead are next and, if necessary a bath in cool water. I understand your concern about fevers, but I am just as concerned about little ones dying of an infection because their body’s immune system was weakened by NSAIDS and did not respond adequately.

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  24. Lina

    Just curious if this also applies to a similar pain reliever used overseas for kids called Adol. I believe it’s the panadol/paracetamol? Would appreciate your feedback! Thx

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    • The Adol I’ve seen is a combination containing a narcotic pain reliever (hydrocodone) and a non-narcotic pain reliever. It does include paracetamol (which is another name for acetaminophen). It’s a considerably stronger pain reliever than acetaminophen alone.

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  25. Eric

    I’m not saying this isn’t true but I am unable to find these recommendations anywhere on the FDA’s website, legitimate news publication or scholarly article/journal. I would really appreciate it if people would cite their sources when making claims of this nature…

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    • Mackenna

      I agree – I keep looking for any information about this, but it seems to only have originated from this site. Even the links in the article are several years old and pertain to the updated dosage recommendations – and say nothing about pain relief vs. fever reduction. Where did this info come from?

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    • Eric – thanks for looking for substantiation – I originally included in the article a link to the original source at the FDA website, but when the official documents were archived, the dead link was removed. Here’s the quote from the minutes of the

      “The committees unanimously agreed that the pharmacokinetic, safety, and efficacy data support the addition of new labeled dosing directions corresponding to a 10-15 mg/kg dose for children 6 months to 2 years of age. The committees also unanimously agreed that new labeling should include an antipyretic claim. However, the majority of the committees agreed that new labeling should not include an analgesic claim because there is no substantial/conclusive evidence that acetaminophen is efficacious in relieving pain in children 6 months to 2 years of age. Please see the transcript for details of the committees’ discussion.”

      And the link to the minutes of the joint meeting of the FDA Nonprescription Drugs Advisory Committee and the FDA Pediatric Advisory Committee now live here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264147.pdf

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    • Here is the link to the minutes from the FDA’s meeting. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264147.pdf

      We’ve also added it back into Dr. Greene’s original post.

      NOTE: The FDA moved their original document to a new URL without redirecting. In an attempt to deal with dead links, the non-working link was removed. After the renewed interest in this topic Dr. Greene went out and found the new link to the minutes of the original meeting that this was based upon.

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  26. Savannah

    We use Tylenol or Motrin sparingly in our household. We also get the suggested dosage from our daughter’s pediatrician based on her weight. In addition to that, we only give it if her fever goes over 101. She’s been teething quite hard and her temperature has been hovering around 99.2. I never suggest for child or adult to medicate when a fever is that low. Usually distractions work with our daughter or cuddling when she’s not feeling well. Febrile seizures can be very serious. Don’t take them lightly. Our daughter has a VP shunt for hydrocephalus and febrile seizures can affect the functionality and setting of her shunt. They could also cause her to have more serious seizures. I say the best thing to do is a combination of your own research and talking to your child’s pediatrician. Something that helps soothe our daughter when it’s been a particularly rough day and just a low grade fever we use coconut oil, mixed with organic cocoa butter, and lavender oil and chamomile tea. It works well rubbing a little on our daughter’s chest or back. The scent is soothing for her. Plus it works well as lip balm and cuticle/hand cream for the parents. Initially our pediatrician suggested something like that. He always goes for natural first if it’s a situation where we can avoid medications.

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  27. Skeptical

    Could someone please link me to the document where the FDA’s Nonsprescription Drugs Advisory Committee and/or Pediatric Advisory Committee recommended that “pain relief” be removed from the label of APAP?

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  28. Sharie

    So where/what is the name of this study? Calling them The advisory panel or the expert panel does not tell me anything. And how did this expert panel that you refer too decide this? Did they interview babies and ask them if their pain went away after taking the Tylenol or placebo? How big was your control group, number of boys and girls, weight of each child take into consideration, average age of the children……..etc?? I can go on and on with questions but my point it you’ve put out a blanket statement with no supporting evidence. Now you have a bunch of parents with their underwear in a twist over what to give for a fever instead of looking at the big issue with this article! I will agree that there needs to be better labeling on medications!

    Parents, stop depending on big pharma to heal and cure your kids. Use your parental gut instincts when it comes to your kids and OTC meds and prescription drugs! Fever reducer is not needed if the fever is under 101. Just let it runs it course otherwise. Your child may not feel well but there is no need medicating them for something their body is designed to take care of.

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    • Great questions, Sharie. The FDA called together a panel of top experts in the field to review ALL of the studies that had been done on pain relief from acetaminophen at OTC doses in kids 6 months to 2 years old, to see if pain relief should be allowed on the label. They found only 10 peer-reviewed studies that met these criteria. The studies used different methods of monitoring pain (such as pain scores in a post-anesthesia unit in the hospital, for example). You can read the summaries of each study in this transcript of Day One of the proceedings, starting on page 71 (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264148.pdf). The largest manufacturer of acetaminophen was asked the next day to provide any additional evidence if available. Or whether the other 12-15 manufacturers had any additional evidence.

      After examining the evidence, the voting members voted 16 to 5 that there was insufficient evidence to put pain relief on the labels. This does not mean acetaminophen works or doesn’t work – just that the studies hadn’t been done for infants and toddlers.

      For your information, the experts included physicians, nurses, pharmacologists, academics, industry, and patient advocates. They were:

      NONPRESCRIPTION DRUGS ADVISORY COMMITTEE (NDAC)
      MEMBERS (Voting)

      Steven C. Curry, M.D.
      Director, Department of Medical Toxicology
      Banner Good Samaritan Medical Center
      Professor of Clinical Medicine
      University of Arizona

      Janet P. Engle, Pharm.D., FAPhA
      Executive Associate Dean
      Professor and Head, Department of Pharmacy Practice
      University of Illinois at Chicago College of Pharmacy

      Neil J. Farber, M.D., FACP
      Professor of Clinical Medicine
      University of California, San Diego

      Winifred A. Landis, R.Ph. C.D.E.
      Pharmacist, CVS Pharmacy

      Norma Martinez Rogers, Ph.D., R.N., FAAN
      (Consumer Representative)
      University of Texas Health Science Center at
      San Antonio, Department of Family Nursing

      Leslie R. Walker-Harding, M.D.
      Chief, Division of Adolescent Medicine
      Professor of Pediatrics
      Seattle Children’s Hospital

      Dorraine D. Watts, Ph.D., R.N.
      Professor, College of Nursing
      St. Petersburg College

      PEDIATRIC ADVISORY COMMITTEE (PAC) MEMBERS (Voting)

      Daniel A. Notterman, M.A., M.D.
      Associate Dean for Research and Graduate Studies
      Penn State College of Medicine
      Associate Vice President for Health Sciences Research
      Penn State University
      Professor, Pediatrics, Biochemistry and Molecular
      Biology, Penn State Milton S. Hershey Medical Center

      Geoffrey L. Rosenthal, M.D., Ph.D.
      Professor of Pediatrics, University of Maryland
      School of Medicine
      Director, Pediatric and Congenital Heart Program
      Executive Director, Critical Care Services
      University of Maryland Hospital for Children

      Alexander T. Rakowsky, M.D.

      Institutional Review Board (IRB) Chair
      Research Institute at Nationwide Children’s Hospital
      Assistant Professor of Pediatrics
      Division of Ambulatory Pediatrics
      Nationwide Children’s Hospital

      Kenneth E. Towbin, M.D.
      Chief, Clinical Child and Adolescent Psychiatry
      Emotion and Development Branch
      National Institute of Mental Health (NIMH)
      National Institutes of Health (NIH)

      Victor Santana, M.D.
      Member, Department of Oncology
      St. Jude Children’s Research Hospital

      Joseph L. Wright, M.D., M.P.H.
      Senior Vice President
      Children’s National Medical Center
      The Child Health Advocacy Institute
      Washington, DC

      TEMPORARY MEMBERS (Voting)

      Amy J. Celento
      (Patient Representative)
      Nutley, NJ

      Susan S. Baker, M.D., Ph.D.
      Professor of Pediatrics
      Co-Director Digestive Diseases and Nutrition Center
      Women and Children’s Hospital

      Michael R. Cohen, R.Ph., M.S., Sc.D.
      President
      Institute for Safe Medication Practices (ISMP)

      Richard Neill, M.D.
      (Acting Chair)
      Vice Chair, Department of Family Medicine and
      Community Health
      University of Pennsylvania

      Ruth M. Parker, M.D.
      Professor of Medicine and Public Health
      Emory University School of Medicine
      Atlanta, GA

      Marcus M. Reidenberg, M.D., FACP
      Professor of Pharmacology, Medicine and Public
      Health
      Weill Cornell Medical College
      New York, NY

      Marie R. Griffin, M.D., M.P.H.
      Professor, Department of Preventive Medicine
      Vanderbilt University Medical Center

      Gary A. Walco, Ph.D., ABPP
      Professor of Anesthesiology
      University of Washington School of Medicine
      Director of Pain Medicine
      Department of Anesthesiology and Pain Medicine
      Seattle Children’s Hospital
      Seattle, WA

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      • Sharie

        Thank you for the info! I’m still not 100% sold on this pain relief issues. My kids are almost 9 and 15 and have managed to survive with me using my mom instinct. Myself on the other had have had to fire Drs because they want to treat me like lab numbers and put me on drugs for Fibro that come Christmas time you see the commercials for them as antidepressants. All approved by the FDA!! Especially when I don’t have fibro, I have Hasimotos! I really don’t think the FDA has mine or anyone else’s heath in their best interest, only the pockets that they line.

        I believe every person’s body is different and will react to the same drug in a different way. Child A may not get much help from Tylenol for pain or fever as Child B. We as parents need to know that we are doing what we feel is best for our child who doesn’t have a voice yet and not be scared by what the FDA has to say about it.! Just my two cents.

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    • Sylwia

      Yup, my thoughts exactly! As there is little known effects of placebos in children ( and under 2 ????) how did they come about being experts on that? .. Where’s the proof… And as you I agree better labeling would be great, no meds for fever under 101 (or actually as per my pediatrician as long as my child acts like him/ herself or the highest ‘allowed’ for their age), plus I do like natural over the OTC. When it comes to pain management I go by my own and my kids and my family and friends Not studies posted on internet..

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      • Sylwia – these were not experts in the placebo effect, but were physicians, nurses, pharmacists and patient advocates who were experts in OTC medications and/or pediatrics.

        They were called on by the FDA to review all of the studies about whether we can say that acetaminophen reduces fever or relieves pain in kids 6 months to 2 years old at oral OTC doses. They found compelling evidence that it does reduce fever. They were unconvinced that it does relieve pain.

        It may or may not relieve pain for a specific child – but we should take manufacturer’s claims that it does with a grain of salt.

        This was not an Internet study, but an in-person meeting reviewing all of the peer-reviewed studies available relevant to this question. The meeting minutes are here: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/NonprescriptionDrugsAdvisoryCommittee/UCM264147.pdf and the section of the meeting on pain relief is on page 6.

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  29. Kim

    I’m just amazed that my children are alive and completely healthy (haven’t been sick in over 15 years) and very intelligent. They are now 25 and 27. I gave them ibuprofen and Motrin with every fever and pain issue. It took the fever away and the pain, making them more comfortable. I also have them their immunizations, spanked when doing a bad thing, let them play outside in the neighborhood, and if they didn’t like dinner they say there till they are it or went to bed hungry. Things are getting way out of hand these days! My boys are smart, well educated with good grades, are responsible, courteous, generous and HEALTHY! Stop freaking out these new mom’s with all this nonsense. All these studies showing everything getting worse for our children. The internet and new ways of recording illness and side effects are causing these increases. They didn’t have this technology back “in the day” so it’s just common sense these things would increase. My grand children are raised the way I raised my children and are as healthy and intelligent as my children. Just use your common sense when treating your children or ask your parents (exception is serious conditions that a Dr. or hospital are needed). This is my way of thinking and you can do what you feel is right for your child, but this scaring new parents is getting out of hand.

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    • Branwyn Kimble (elfennau)

      I am so sorry for your children that you hit them, no matter what the offense was. You seem to imply that’s why they are “smart, well educated with good grades, are responsible, courteous, generous.” And yet, my four children – ages 23 down through to 11 – are all of the above, and have never had a hand laid on any of them in anger or as a punishment even once in their lives. They love me, he respect me, and they value my opinion of them so highly that even disappointment at any of them is enough to bring tears to their eyes – and thankfully, that is a rare event because I so rarely have a reason to be disappointed in any of them in the slightest.

      While I agree with you that some ideas of parenting these days are getting out of hand, there is never ever any excuse for violence toward children for any reason.

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      • rebecca gibson

        YOU are a complete moron, this is going to the above comment.. A spanking and getting “hit” are two different things. Apparently you lack common sense. Don’t be a judgemental prick because someone parents different then you. You are no better or any less.

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      • Lisa

        WOW! REALLY??? FROM THAT STATEMENT YOU FELT THE NEED TO GO ALL IN AND MAKE THIS ABOUT VIOLENCE? SHAME ON YOU ! KIM GREAT PARENTING ADVICE! GOD BLESS YOU ALL :-)

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  30. Cat

    There are no links to sources backing up this claim about the pain-relieving effects of Tylenol, so why do people keep blindly believing this and reposting it on social media? I wouldn’t be surprised if it turns up on Snopes dot com soon.

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  31. Kelly

    So what do you gve children for pain? Alternatives?

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    • John Wilkinson

      Calcium and Vitamin E, oddly enough. The body will increase it’s pain tolerance with enough Vitamin E and Calcium is a great, great, great pain reliever.

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      • Susan

        How much vitamin E and Calcium and are they given together?

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    • Nicole

      If the child is over 6 months, Advil. It also reduces inflammation do it would work better to ease teething pain anyway. No matter your child’s age, I would consult your pediatrician before administering any medication for a new symptom.

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    • senior cancer pharmacist

      Pass the pipe obviously.

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    • Amelia

      Unless your child has some rare and painful disease, there’s really no reason to give pain relievers. Nursing your child will give comfort and pain relief.

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      • leslie

        Not all children have mothers! And not all mothers can nurse. I think this is a very ignorant suggestion.

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      • Bridget Willis

        Really? I don’t see how you think that! That is total bs, try soothing a baby with an ear infection top relieve pain, it doesn’t work! I’m not sure what you’ve been smoking but, I had one kid with continuous ear infections and one that had fevers every month (some in the range of the 105*+ mark) from birth till she started kindergarten. No amount of nursing/cuddling would bring fever nor bring pain relief!

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  32. Jeff

    Just to be clear; no one is saying that acetaminophen is unsafe. The point is that it’s not likely an effective pain killer for children under two. In fact, acetaminophen is incredibly safe when taken properly.

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    • lilmomma

      Actually, I have never found tylenol to be a pain reliever for myself…so I have never given it. I just do not feel like it helps me at all, so I never assumed it would help them. And I agree, it IS very safe when taken appropriately. Most of the problems with any OTC come with improper usage, off-label usage, or over use of a medication. However, I also feel that parents are often misinformed or simply not well informed of many things regarding many medications.

      A study was released several years ago that proved that giving tylenol or motrin for fever reduction following vaccinations to reduce fever also reduce titer results & therefore the conferred immunity of said vaccines, reducing effectiveness. Is it huge? No, not a huge difference, but it is notable reduction.

      Many parents think a fever itself is part of an illness like a runny nose, when in fact fever is an immune system response launched to fight the infection. The brain itself causes & controls the fever in order to inhibit reproduction of bacteria & viruses within the body & thus fight the illness. Even in what most call high fevers, this is the case. Unless a child has meningitis or encephalitis, where the brain’s function could be impaired…and thus not controlling the fever, the fever is meant to heal. The other exception being when dehydration could be in play, as fever can speed that.

      Sorry for the book on it. I don’t want parents to be MORE scared…I want them more informed so they are LESS scared. 99% of fevers, even ones that seem high are NOTHING to fear.

      With my own kids (3) I have actively tried to reduce fever once, ever. And that was a dehydration issue on a low grade temperature. I used Feverall suppositories (wonderful for vomiting) and it is acetaminophen (Tylenol). My kids have rarely had even a cold longer than a few days at most and I think part of this has to be I allow their bodies to fight illness with fever.

      And I would urge all parents, if they fear febrile seizure to read up on them. They happen due to how fast a temperature raises, not the actual number on your thermometer, and they are not nearly as scary as they look. They do look scary, very scary, but if you look at the studies, you will see for yourself that they are not associated with serious health risk. If a child has a seizure though, they should always be medically evaluated to ensure there are not any other underlying conditions. But we should try to get ourselves informed about these things when our kids are well, so if we ever face them we don’t overreact due to lack of understanding.

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      • Shelly

        Well for both my kids, I had to alternate ibuprofen and Tylenol because a slight fever would always go over 104, and the worst time my son was 107 by the time he got to the hospital. If I keep on top of it they work great for fever. I try to get them to eat Popsicle’s to lower their core temperature.

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  33. Ortho Nurse

    “… because there is no reliable evidence that it relieves pain better than placebo in children under age two.”

    I would also conjecture there is no reliable evidence that a placebo relieves pain better than acetaminophen in chidren under age two either.

    I have taken care of infants and toddlers for over 15 years. I will take actual experience treating children with broken bones and 2nd degree burns over a study that has a specious method of guessing the amount of pain an infant or toddler is experiencing, acetaminophen or placebo. When treating pain in children a multimodal techique must be employed, using emotional support, distraction and other comfort measures along with appropriate pharmacological intervention. Every person, from age 6 months to 60 years, responds to pain differently. Just because a child is still, not crying or reacting to stimuli doesn’t mean the child is not in pain: I’ve done enough burn dressings to know that some kids shut down, go almost away from themselves, to escape the agony they are experiencing.

    As for the part about dosing being based on weight, and not age, I wholeheartedly agree. But go ask pharma why the instructions are the way they are… Or better yet, in the Metric-impaired USA, explain to the public that many of them are considered to incompetent to do the math required to figure out a safe dose of acetaminophen. If you don’t like the labelling, then fix the labelling: don’t write off the medication because it has poor usage instructions.

    Oh, and the calculation my insititution uses to determine safe, Q4H ATC administration is 12.5 mg/kg/dose. Do not exceed 4g in 24h.

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    • Telenurse

      Thank you for this response! I wholeheartedly agree!!

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    • Louise Svingen RN

      I would guess that 4gm in 24 hours max dose is much too high for children.

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    • Jennifer

      Thank you! Totally agree with what was stated here. It’s difficult to assess pain in people under two as not all can point or associate their pain with words, pictures or gestures.

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    • lilmomma

      I completely agree on the shut down in infants & children. I have seen a child in severe pain go to sleep. It is why I get upset when people claim circumcision doesn’t hurt, as if you can tell what a baby feels. I have seen a baby in extreme obvious pain go into what appeared to be a deep sleep, almost instantaneously without any pain relief (eye issue, which we all know is HIGHLY painful). You can’t ever convince me that you “can tell” whether or not a child is in pain by observing them. I am sure there must be other measures (cortisol, blood pressure, heart rate) that could indicate, but never visual observance.

      And we were taught in pharmacy to calculate similarly, and I think people often forget they can call their pharmacist about medication dosage at quite flexible hours. No need to try to figure it out alone.

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  34. April Bowen

    I have six kids, ages 15 through 28, and we have never once used Tylenol, Ibuprofen, Motrin, Benadryl or any other OTC drugs. Homeopathic remedies are all we’ve needed and they work great at both rapidly relieving any pain, but also at healing whatever disease or injury that has occurred. I AM a homeopath, now, but I started out as just a mom that needed to care for her children, Anyone can (and should!) learn how to treat common, everyday ailments with homeopathy. Even your kids will soon pick up on when to use basic remedies. Once you’ve seen it work like magic before your eyes, you’ll never look back!

    Here are two resources I recommend, though there are many others:

    Homeopathic Self-Care: The Quick and Easy Guide for the Whole Family
    by Robert Ullman and Judyth Reichenberg-Ullman
    This is still my all-time favorite book to use for almost any problem you’ll have in childhood. It’s very simple to understand and navigate and helps you choose between different remedies for common ailments.

    Washington Homeopathic Products
    I highly recommend purchasing their Top 100 Remedy kit if possible. It’ll be the best investment and insurance in your family’s health, as you’ll have most commonly needed remedies at your fingertips. Refills are only $4 or $5, depending on the potency.

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    • kathryn

      Homeopathic mixes can cause potential harm in children as well. What ever you use it is the dose and risk you take as a parent. For eg. Deadly Night shade, or belladonna that is often found in teething relief also can cause bad side effects if given too much. There for I try to give all meds as a last option, but if my baby is showing me nothing i do is working, then i give her what i have found that does let herrelax and get some relief so she can sleep and get what she needs to get better.

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      • Steve C

        No, homeopathic mixes can’t cause any harm, ever. You know why? They’re nothing but water, there is nothing in any homeopathic solution but water or sugar. Go take an entire bottle of homeopathic sleeping pills, you’ll wake up just fine the next day.

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    • #realmedicine

      I can use the water tap in my kitchen. That’s all the homeopathy training I need.

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  35. cipp

    No medication for a fever?????? That’s how fever temperatures spike and children have febrile seizures. How else can we control that?

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    • HEather

      Essential oils!

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      • Bridget Willis

        I went to an essential oil seminar, I started getting a headache and a stuffy nose when I walked in! They had their newest plug in plugged in, I felt horrible by the time I left!

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    • sue

      He didnt state no meds for a fever. Low grade fevers are a sign the body is doing the right thing and fighting the infection. The risk of febrile seizures comes with the rate at which a fever rises. The quicker the more likely. He did state that tylenol is appropriate for fevers in certain cases (like poor fluid intake and sleep) just not for pain.

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    • Bob

      “Fevers may also be useful because they increase the amount of antiviral and anticancer interferon in the blood, making it difficult for bacteria and viruses to replicate.” http://www.medicalnewstoday.com/articles/9895.php

      People are over medicating, causing medication-resistant bacteria and viruses. I would consult your doctor.

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      • Jay

        Tylenol and other OTC medications have nothing to do with resistant bacteria. Also, there is no such thing as resistant viruses. Viruses in them self can rarely be treated…only the symptoms can be managed.

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    • Molly

      Febrile seizures aren’t a horrible thing, though. They aren’t the same as a “seizure”.

      My son’s very first fever involved a febrile seizure. Sure, it was scary, but I called his doctor and she said it was nothing to worry about. She had us get into a bath of tepid water, to slowly and gently bring his temperature down if he seemed uncomfortable (he did so we did), and it worked beautifully. We have NEVER *given* him anything for a fever; sometimes we use the tepid bath if he’s not happy with the fever. Never had another febrile seizure, not even when he was working on his primary canines and his temperature hit 104 2 nights in a row, under the arm, with an ancient mercury thermometer (we were traveling and didn’t have our ear thermometer).

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      • Melanie

        Um, febrile seizure are *not* something to be taken lightly. My husbands uncle was irreversibly brain damaged because of a febrile seizure when he was a child. I’m pretty sure his parents wished they had just given him medication to bring it down quickly.

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        • Amelia

          I’m guessing that your uncle-in-law was diagnosed long before febrile seizure were well-studied. NIH has concluded that 98% of febrile seizures are completely harmless, and the other 2% are only harmful because the children injured were already brain-damaged in some way or because the seizure caused a fall that resulted in external injury.

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          • lilmomma

            Agreed. I have also heard old stories of fever causing deafness, blindness & blamed for a multitude of other problems that were in fact caused perhaps by an illness, but not by the fever itself. You can hardly blame anyone for believing it is true though when that is what we were told was medical fact way back, because it was thought to be true. We just need some sort of public re-education on general health.

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        • Richard Feuille

          Your husband’s uncle must have had encephalitis or meningitis. Typical febrile seizures don’t cause brain damage. There are genetic conditions that cause brain abnormalities and seizures with fever, as well. This is quite different from a typical febrile seizure.

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      • Louise Svingen RN

        I find the ear thermometer gives a different reading each time you use it even just seconds apart.

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    • anonymous

      A fever is considered anything above baby’s normal. There’s a big difference between 99 and 102. If your baby is around 101 then by all means give him some Tylenol. But the low grade temps around 99 and 100 are more beneficial than the meds.

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      • lilmomma

        A fever is anything above 101 (young infants have a different scale). And elevated temp is anything above normal, below 101. At 101 it is a low grade temp at best & requires no intervention at all. They aren’t even considered moderate until past 102. If you actually took your child’s temp daily at various times you might be surprised to see they also vary in temp quite often in absence of illness. My own kids commonly could be found near 100 at end of day, ever.single.day. I started checking them after reading an article & low & behold..99 to 100 is totally normal for my kids at some point in every evening. LOL So if I were treating them based on 100, I would be treating nothing at all. In fact if they have been running hard I can catch 101 to 102 on occasion (quickly coming down when they rest). I assume this may be at least in part why exercise helps reduce illness in people.

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        • Bridget Willis

          99* is actually a fever for myself, my average temperature is between 95-96* so, by the time my temp reaches 101* it is quite high!

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    • misty

      That’s quite rare. I personally bathe my children in a Luke warm bath and keep them hydrated. What is the actual temp of danger? It’s really high, 105* maybe? People are dosing with Tylenol at 100* often! Your talking of an extreme and frankly those cases are just not the norm.

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    • Treva

      My son a febrile seizure 1.5 hours after I gave him a full dosage of tylenol. ER doc told me meds don’t prevent them. We use essential oils now for fever reduction, but only if it is causing my boys too much pain.

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    • Selena

      There are other ways to reduce a fever. A tepid bath being one. But, it doesn’t say never give it to reduce the fever, it says to let a fever run it’s course if it is not interfering with the child’s ability to sleep and retain liquids. I don’t medicate a fever unless is it above 101. I have always known that a low grade fever is good. BTW, my nephew suffered from febrile seizures. It is the spiking that causes the problem. Both times he had one in my care, it was because he got too hot too fast.

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    • Gabby's Mom

      Just a side note, fever is the body’s natural immune reaction to an infectious process, which is how the body kills said infectious process. There are other ways to help a fever. Please don’t hear me wrongly, I am a “tylenol mom,” but tepid-to-cool baths and pushing fluids do work, also. Hospitals won’t even gove tylenol until a fever has reached 101.5 anyway.

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    • Kyla RN

      Unless a fever rises above 104.0 there is no reason to give any OTC medications unless it is impeding your child’s ability to drink or sleep. Allow the fever to do its job and activate the immune system and fight off whatever infection is brewing.

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      • Richard Feuille

        Nor is there a reason for Temp>104. It takes temps over 107 to cause harm. And, fever control does not prevent febrile seizures.

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  36. Sara

    About 6-7 years ago I came across a small article in the American Speech and Hearing Association paper re a study that warned pregnant women about using Tyelonal due to increased risk of autism for baby down the road.

    I have always wondered about an autism and Tylenol connection. Years and years ago parents used children’s aspirin (I remember the orange flavored pills). After the Rye syndrome scares, we all switched to Tyelonal.

    There has always been talk about vaccinations and autism. I know there is no connection. After the 18 month MMR vaccine, parents allegedly saw signs of autism appear – the vaccine was blamed. Has anyone looked at the Tyelonal though instead. Many recommend giving it before the shot and after.

    Also, I know that a Florida State University study looked at first birthday videos of children later diagnosed with autism/PDC and there were signs before ther vaccine at 18 months.

    A very interesting discussion. I’ve just always wondered about a autism/Tyelonal connection.

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    • Youcantbeserious

      Hahahahaha oh my goodness you think Tylenol causes autism but not vaccines hahahahahahaha

      Have you ever read a vaccine package insert? Heavy metals, animal cells, live and mutated viruses, aborted fetal cells. .. or maybe the portion of the insert stating the possible adverse reactions? Hmmm doesn’t seem like you have.

      But Tylenol tho……

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      • Nicholas

        And you apparently haven’t read any real autism research. Autism starts in utero, due to the changes in the brain seen. These parts develop early in pregnancy. Their brains overwhelming show a highly disorganized frontal cortex. This couldn’t be caused by autism because its already there. Could Tylenol or some other medication taken during pregnancy cause it? Maybe, no one knows. Probably something hereditary.
        As far as tylenol and pain, I know it works for me and I know its worked for my kids. They are past that point so I’m not too worried about it. Hard to believe that it works in young kids but not babies and I agree there is no good way to tell.

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        • Sara

          “Autism starts in utero, due to the changes in the brain seen” – hence the article I saw in the ASHA journal. It may not happen for all but may be a trigger.

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      • Sara

        Never said that “Tylenol causes autism”…I wondered about a connection between the two.

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  37. Ailsa

    Interesting. But does reducing the fever actually interfere with the immune response? Also let’s not discount the misery for child (and parents) which can be relieved with the odd (correct) dose of acetaminophen, nor the role played in minimizing the likelihood of frightening febrile seizures. Are you aware of recent studies linking acetaminophen with worsening symptoms in infants and children with reactive airways? Those would suggest other good reasons not to give acetaminophen.

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  38. Heather

    What about Motrin infant drops? It does not contain acetaminophen. The active ingredient is Ibuprofen. I very rarely give my daughter any sort of medication. But if she is in pain and the physician has recommended giving her something, I would like to ensure what I am giving her is actually going to help and not cause needless harm to her little body or liver.

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    • Teri Williamson

      Motrin (ibuprofen) is metabolized by the kidneys, & not the liver & is generally safe, but don’t give it if the child is dehydrated. The child needs to be able to drink plenty of fluids to prevent kidney complications.

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  39. Megan Fincham

    If we shouldn’t give Tylenol for pain, would you mind sharing your suggestion on what should be given? Thanks!

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    • Tania Hilton

      Essential oils works wonders in our home! I’m treating an ear infection now with EO.

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      • Youcantbeserious

        Oh do say how are you using these oils?

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  40. Patrick McGean

    Tylenol kills liver cells in adults imagine what it does in children who can not vocalize the pain.
    Organic sulfur a crystal food works better than morphine and medical marijuana for pain, any
    pain. In biology pain is the absence of intracellular oxygen transported by sulfur, selenium, and tellurium, and nothing else.
    Consider the biology you created in a heat of passion, consider your own.

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  41. Marianne

    Thank you for validating what I have been practicing for my daughter for the past three years. Whenever my daughter gets a fever (and not even very high), my husband freaks out and want to give her acetaminophen to bring down her fever. I keep telling him that that does the opposite of helping her to overcome whatever sickness she has–like turning of the water when your house is burning down. Two weeks ago I took my daughter to the children’s hospital on the advice of her pediatrician to get a second opinion on the type of virus she had (it was causing her to have a bunch of ulcers in her mouth that made it painful to eat.) The attending doctor said that there was nothing they could give her since it was a virus, but that I should give her acetaminophen for the pain. I told the doctor that I didn’t want to hurt her kidneys and liver just to ease of of a little pain. I think she thought that I was a little nuts, but I’m glad that I stuck to my guns and listened to my mommy intuition. (She was still able to drink water and eat some yogurt, so I wasn’t worried about her dehydrating.)

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  42. christine

    Is this true I use infant tempra ages 0-23 mo????? This is safe right?

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    • Sara

      I would check to see if infant Tempra is a brand name for acetaminophen (otherwise known as Tyelonal).

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  43. Jan

    Just wondering how this affects infants who would be experiencing legitimate pain as opposed to fever? Both my son and nephew had surgery while under 1 month of age and the infant Tylenol formula was the only approved pain relief. Thoughts?

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    • Youcantbeserious

      If surgery was involved just go with whatever the doctor says.. especially at that young of an age

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  44. spacey

    If you look at the package and the bottle of baby Advil, Motrin and Tylenol it is dosed by age AND WEIGHT. I don’t give my kids Tylenol and I don’t even like taking it myself. I’d prefer Advil or Motrin.

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  45. Bobby Clarke

    “Correction: March 10, 2000, Friday The Personal Health column in Science Times on Jan. 25, about the risks of overdosing on acetaminophen, commercially known as Tylenol, referred imprecisely to the amount that becomes toxic. Treating a child five times a day or more for several days, at the recommended dosage, could result in a build-up to half or more of the toxic quantity. A single dose given once is about 11 percent of the toxic quantity. The drug’s maker reported the error in a letter on Feb. 14, but the writer was away from the office and did not see her mail.”

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