New Dosing Info for Infants’ Acetaminophen

The U.S. Food & Drug Administration is issuing an important warning for all parents and caregivers regarding the potential for dosing errors when giving liquid acetaminophen to infants.

An additional concentration of liquid acetaminophen marketed for infants, 160 mg/5 mL, is now available (it had already been sold, with dosing cups, for children ages 2 to 11). Most consumers are likely familiar with the 80 mg/0.8 mL or 80 mg/mL concentrations of liquid acetaminophen, which may lead to some confusion or dosing errors, especially as the older concentrations may still be on store shelves and in people’s medicine cabinets. The new concentration is less concentrated than earlier forms, which could lead to an infant receiving insufficient medication or making the drug ineffective. Giving too much acetaminophen could possibly lead to death, and in fact, overdoses of infant acetaminophen, some of which led to death from liver failure, are the reason behind this change.  

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Over-the-counter liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat and toothache. Popular brands include Tylenol, Little Fevers, Triaminic, Pedia Care, and generic or store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

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This change in the concentration will affect the amount of liquid given to an infant. Additionally, packaging may contain an oral syringe instead of a dropper.

Because there is no dosing amount specified for children less than 2 years of age, it is important to check with your healthcare provider for dosing and concentration instructions. Parents and caregivers should also be sure to read the information regarding active ingredients to confirm they are using the appropriate concentration.