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Clearer kids' dosing urged for acetaminophen-containing meds
May 18th, 2011
01:36 PM ET

Clearer kids' dosing urged for acetaminophen-containing meds

It's a stressful moment for parents: Your little baby is awake in the middle of the night, crying and screaming with a fever. You reach for the children's fever-reducer in your medicine cabinet but the side of the box says to "ask a doctor" about the appropriate dose for a child under two. But at that hour, you can't reach a doctor. How much medicine do you give your child?

To make that guessing game easier, two FDA advisory committees have voted to recommend that dosing information for children six months to two years old be added to all over-the-counter children's medicines containing acetaminophen. Members of the FDA's Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee held a joint meeting for two days to hear testimony from, among others, the American Academy of Pediatrics, the Consumer Healthcare Products Association, and McNeil Consumer Healthcare, the manufacturer of Children's Tylenol, one of the most common children's medicines that contains acetaminophen.

“Single-ingredient pediatric liquid acetaminophen medicines are safe and effective and parents and caregivers need information to dose appropriately to make them most helpful for children,” according to a presentation overview from the Consumer Healthcare Products Association.

The committees also voted in favor of using a child's weight, not just their age, to calculate an appropriate dosing regimen for all children ages two to twelve. In a prepared statement to the joint meeting, Dr. Daniel A.C. Frattarelli, chair of the American Academy of Pediatric's Committee on Drugs, said the AAP has supported the idea of using weight-based dosings for nearly 14 years because it is a better method of determining how much medicine a child should receive.

“Caregivers who understand that dosing should be based on weight rather than age are much less likely to give an incorrect dose,” explains Frattarelli.

The joint meeting also addressed some of the confusing label instructions and various concentrations of acetaminophen that parents often deal with when they purchase an over-the-counter children's medicine. A recent JAMA study found that parents give their kids the wrong dose of medicine half of the time because the dosing instructions can be confusing. While the committee members did not make any final recommendations, they did discuss ideas to improve the labels, including standardizing the measuring units for all medicines from teaspoons to millilitres, and presenting additional dosing instructions with illustrations.

“By means of regulation, we can restrict how many milligrams per tablet or millilitres per ounce are allowable across all products in the OTC system, says Dr. Sandra Kweder with the FDA.

"Through regulation, we could require that... the products be packaged with dosing devices that meet certain standards,“ she says.

The committees  also voted to make all over-the-counter solid acetaminophen-containing medicines available in a single concentration, to avoid possible overdoses of the drug. For parents, that means liquid children's medicines will not have more or less acetaminophen than medicines that come in a pill form.


soundoff (33 Responses)
  1. courtney

    That's great! About time.

    May 18, 2011 at 14:20 | Report abuse | Reply
  2. Trisha

    finally! great news.....

    May 18, 2011 at 16:14 | Report abuse | Reply
  3. Lynnette

    Thank goodness! Finally someone remembered kids under 2 get sick too!

    May 19, 2011 at 00:41 | Report abuse | Reply
  4. JustinFromNJ

    Excellent. Acetaminophen overdose, especially in infants, is extremely common, and extremely dangerous. Age-based dosages can be significantly off of what the proper dosage should be.

    Acetaminophen is one of the most dangerous over-the-counter medications out there. It is also one of the most effective for fever when properly used.

    May 19, 2011 at 02:17 | Report abuse | Reply
  5. Elizabeth

    Finally! Thank you!

    May 19, 2011 at 08:32 | Report abuse | Reply
  6. dom625

    Isn't this why we have infant Tylenol? For the under-two set? And isn't that based on weight anyway?

    May 19, 2011 at 09:15 | Report abuse | Reply
    • turtlesoup

      Infant tylenol and the equivalent generics currently come with over two dosing only. Even on the infant stuff. I wish I were kidding.

      May 19, 2011 at 11:45 | Report abuse |
  7. mamaAnna

    Yes, finally!

    @dom625 - they do not print the dosage for weight on the bottles of infant Tylenol. This would change that and make it easier for parents with little ones.

    May 19, 2011 at 09:40 | Report abuse | Reply
    • dom625

      There is a chart printed clearly on the back of the box that the infant Tylenol comes in. And I'm talking about the dropper-type, not the children's type that comes with a small dosage cup. There is also a small chart on the label of the bottle. So this is already in effect.

      May 19, 2011 at 11:12 | Report abuse |
  8. Ana

    Breastfeed babies so they don't get sick and need medications. I did with both my kids and they never got sick until age of 3yr and 4yr.

    May 19, 2011 at 10:42 | Report abuse | Reply
    • momma

      the only problem with that statement is that not every single mother is able to breastfeed. i didnt produce enough to feed my kids. i had no choice but to use formula

      May 19, 2011 at 11:09 | Report abuse |
    • EdPaul

      They also know calculus and can fly by 5. ...Oh my! Somebody drank the LaLeche ladies' Koolaid.

      May 19, 2011 at 11:20 | Report abuse |
    • dx2718

      I breastfed my daughter until 18 months. No supplemental formula ever. No cow's milk until she was well over a year. She got sick once with a fever even before she went to daycare! After going to daycare, she was sick a *lot*. We also gave her tylenol when she was cranky and feverish after shots (2 months, 4 months, etc.). Breast feeding does not prevent kids from getting sick, sorry – though having them get sick earlier (like before the age of 3-4) helps their immune system develop so they get sick less when they're in school.

      May 19, 2011 at 12:15 | Report abuse |
    • Ray

      Unfortunately, breast feeding does not PREVENT sickness. There are plenty of children that get sick who are breastfed, there are many contributing factors. Pediatrician's need to educate parents on the proper dosage of common OTC medications whether or not dosages are available on the box. My childrens' office gives out a chart of dosages to help eliminate confusion and empower the parents to act rather than sit and wait for the doctor to call back in the middle of the night.

      May 19, 2011 at 12:17 | Report abuse |
    • Rocksor

      Kids don't get sick because they are not exposed to other sick people. I bet your kids weren't put into daycare before the age of 3.

      May 19, 2011 at 13:24 | Report abuse |
    • Cassie

      Even if a baby is breastfed, they still get sick by being exposed to other sick people. Even if they are breastfed, they still cut teeth, it can be painful – tylenol can help a lot.

      May 19, 2011 at 14:02 | Report abuse |
    • PennyNot

      I breast fed too but they still caught some colds. My youngest had a seizure induced by a spiked fever at 18 months. Breast feeding is better but not a cure all, especially if your children are in day care as mine were. And yes, I pumped and provided breast milk for the sitter too.

      May 19, 2011 at 17:44 | Report abuse |
    • Donna

      That is a sweeping statement! I breastfed and my son still got sick. Breast feeding is not a cure all. There are air borne pathogens as well and blood and water. You can fight particulates and microbes with the milk in your breast.

      May 19, 2011 at 19:58 | Report abuse |
    • bertha

      I'm 38 – mum breastfed me until iI was well over 2 yrs old (no kidding). Throughout my life, I don't ever remember getting sick but twice. Even then it was a cold, nothing major. I caught chickenpox @ 19 when it usually has fatal consequences. I got over it ion 24 hoiurs. Even mum, a doctor by profession (OB/GYN) was puzzled and insisted a medic check me out. They did and did a CBC, turned out my white blod cells – those guys that are in charge of immunity in our bodies – number far above that of the average person, I have hjad more CBC's done, and every time, the results are the same. My WBC count is always at least 35% higher than thew normal average. NO, I do not have leukemia, and the last time I got a cold was 21 years ago! I have no headaches. No allergies. No hearborn., None of the common average people afflictions related to health....was it because of mama's milk? I don't know, but I'm open to any suggestions

      May 25, 2011 at 15:35 | Report abuse |
  9. Gene

    It's about time to remove that "ask a doctor" sign. Parents don't run to their pediatricians whenever a child has fever, they come to the pharmacy first. As a pharmacist, I know how much tylenol would be appropriate for a child, but I can't really tell that to parents due to that sign. At least they should add "ask a doctor or a pharmacist."

    May 19, 2011 at 12:08 | Report abuse | Reply
    • kirstyloo

      Parents need the information when neither a doctor or a pharmacist is available. Our Ped gave us a weight based chart, and I wrote the info on the bottle...because who knows if I could find the chart when I needed it. Make it easy...and put it there in the first place!

      May 19, 2011 at 18:47 | Report abuse |
    • mark

      A pharmacist is a Doctor of Pharmacy, no? I am a medical doctor and my wife is a doctor (of education) too – I do not believe it says to ask a MD/DO – so I do not think that label has any legal standing for pharmacists to take a step back...

      May 23, 2011 at 02:42 | Report abuse |
  10. dx2718

    Thank you!! It's so annoying to call the pediatric on-call line just to ask about dosing, and I feel bad for parents that don't even have that option. The dosing chart that the doctors use is already available online, so why not just put in on the package for easier access!

    May 19, 2011 at 12:17 | Report abuse | Reply
  11. b

    An important thing to know about acetaminophen (Tylenol) is that the infant drops formulation is more concentrated than the children's liquid formulations. The infant drops contains 80mg/0.8mL, the childrens liquid contains 160mg/5mL. The rationale for that is that getting a concentrated formula into a fussy, ill infant is easier than trying to get a larger volume into an ill infant.

    May 19, 2011 at 12:43 | Report abuse | Reply
    • Al

      The last paragraph makes it sound like that will no longer be the case. Make the toddler take the higher concentration (worse tasting) or try to get an infant to ingest a larger total volume of liquid....brilliant!

      May 20, 2011 at 04:18 | Report abuse |
  12. Tori

    This is excellent, especially in the computer age. People look up doses on the internet, then give the wrong concentration and od their kids. Dosage should be included on every package.

    May 20, 2011 at 19:06 | Report abuse | Reply
  13. bertha

    I'm 38 – mum breastfed me until iI was well over 2 yrs old (no kidding). Throughout my life, I don't ever remember getting sick but twice. Even then it was a cold, nothing major. I caught chickenpox @ 19 when it usually has fatal consequences. I got over it ion 24 hoiurs. Even mum, a doctor by profession (OB/GYN) was puzzled and insisted a medic check me out. They did and did a CBC, turned out my white blod cells – those guys that are in charge of immunity in our bodies – number far above that of the average person, I have hjad more CBC's done, and every time, the results are the same. My WBC count is always at least 35% higher than thew normal average. NO, I do not have leukemia, and the last time I got a cold was 21 years ago! I have no headaches. No allergies. No hearborn., None of the common average people afflictions related to health....was it because of mama's milk? I don't know, but I'm open to any suggestions :)!

    May 25, 2011 at 15:32 | Report abuse | Reply
  14. L

    This is great for teething and low fevers/aches, but I guess I'm a little confused as to why it was perceived as such a problem. We've had 3 kids, each in a different state, and EACH pediatrician we saw for that first (and subsequent) vaccination appointment would first ask if I had Tylenol or Motrin on hand. Regardless of the answer, s/he would offer to prescribe a bottle of infant acetaminophen or ibuprofen, as well as write down the dose for my child. I guess I had assumed that parents had been told several times what dose to give their babies when necessary. I thought that "ask a doctor" thing was annoying, but mainly there to protect the little ones in case something more serious was going on and the doctor could instruct the patient to come in or head to the ER.

    May 27, 2011 at 17:45 | Report abuse | Reply
  15. ARW

    Your child's pediatrician should tell you at your well baby check ups what the appropriate dosing is for medicine.

    May 28, 2011 at 22:16 | Report abuse | Reply
  16. Johnette

    The voice of ratnoiality! Good to hear from you.

    December 25, 2011 at 06:43 | Report abuse | Reply
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  19. hizxcellenci

    wow. this is very imformtaive and educative

    October 14, 2019 at 20:22 | Report abuse | Reply

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