Infant acetaminophen dosage change may cause confusion

Double check the label on liquid acetaminophen before giving it to a child or infant to avoid giving your child the wrong dose.

The FDA is urging parents and caregivers to carefully read the label on liquid acetaminophen marketed to infants and children as a new, less concentrated form of the popular pain reliever arrives on store shelves.

Acetaminophen products include several over-the-counter brands, including Little Fevers, PediaCare, Triaminic, Tylenol, and store brands or generic versions of the drug.

While the new 160 mg per 5 mL concentration is now arriving in drugstores, much of the older, more concentrated 80 mg per 1 mL or 80 mg per 0.8 mL versions may still be in people's medicine cabinets.

"There is still some on store shelves; there is still some in homes; and there is still some in distribution," Carol Holquist, director of the FDA's Division of Medical Error Prevention and Analysis, says in a news release. "Be very careful when you're giving your infant acetaminophen."

Giving too little liquid acetaminophen could cause the drug to be ineffective. Giving too much could possibly lead to death.

The drug is used to temporarily reduce fever and relieve minor aches and pains from the common cold, flu, headache, minor sore throat, and toothache.

Why the New Version?

Until recently, liquid acetaminophen marketed for infants was available only in the stronger 80 mg per 1 mL or 80 mg per 0.8 mL concentrations that don't require giving infants as much liquid with each dose. Meanwhile, the less concentrated 160 mg per 5 mL version was marketed for children.

Earlier this year, a report from the FDA showed that confusion caused by the different concentrations of liquid acetaminophen for infants and children was leading to overdoses that made infants seriously ill, and some died from liver failure.

To avoid these dosing errors, some manufacturers voluntarily changed the concentration of liquid acetaminophen for infants to the same concentration as the liquid acetaminophen marketed to children.

The new, less concentrated 160 mg per 5 mL liquid acetaminophen for infants has new dosing instructions and may have a new dosing device in the box, such as an oral syringe rather than a dropper.

What You Should Do

The FDA advises parents and caregivers to read the "Active ingredient" section of the Drug Facts label on liquid acetaminophen marketed to infants or children to tell the difference between the two products.

Other tips for ensuring safe and accurate dosing of liquid acetaminophen include:

• Do not depend on a banner proclaiming that the product is "new" to determine the drug's concentration. Some medicines with the old concentration also have this word on their packaging.
• Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
• Consult your pediatrician before giving this medication and make sure you're talking about the same concentration.
• If the dosing instructions provided by your health care provider differ from what is on the label, check with a health care professional before administering the medication. Do not rely on dosing information provided from other sources, such as the Internet, old dosing charts, or family members.

FDA officials say it is important to note that there is no dosing amount specified for children younger than 2 years of age. If you have an infant or child younger than 2 years old, always check with your health care provider for dosing instructions.