Changes to Pediatric Chewable Acetaminophen Products

By Margaret M. Burke, Pharm.D., BCPPS

Acetaminophen is a medicine used to relieve pain and decrease fever. It may be purchased “over-the-counter” which means you do not need a doctor’s prescription to get it. Some brand names for acetaminophen made for children include Tylenol®, Pain & Fever®, or Mapap® but there are many more available.

Many makers of chewable acetaminophen products have recently switched from making two different tablet strengths, 80 mg and 160 mg, to making just one chewable strength, 160 mg per tablet. Manufacturers did this in response to a FDA Advisory Committee recommendation. However, the FDA did not require manufacturers to make this change so both strengths may still be available in stores or in your medicine cabinet.

What should you do?

Check your medicine cabinets to see what products you have. Read package labels carefully when you buy more. Over-the-counter packaging contains a panel labeled “Drug Facts” that lists the active ingredient(s) and amount of each ingredient in the product. Read the package and ask a pharmacist any questions before leaving the store.

Is it OK to still use the 80 mg product?

Yes, as long as the packaging shows it is still within its expiration date and you give the correct dose according to the instructions for use.

Communicating with your children’s healthcare providers:

When asking for directions about giving any medicine to your child, tell the provider what product strength you have and always ask the provider what DOSE you should give. The dose will usually be in milligrams or grams depending on the medicine. If the medicine will be a liquid ask what DOSE and how much VOLUME you must give. You could make a mistake and give the wrong amount if you or the provider only talk about how many tablets or teaspoons to give.

Don’t rely on terms like “Children’s” or “Junior” strength to describe doses. These terms may change meaning over time. This recent acetaminophen change is a good example. The 80 mg tablets were “Children’s” and the 160 mg tablets were “Junior.” Now the 160 mg tablets are called “Children’s.”

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