FDA Warns About Infant Acetaminophen Dosing

Infant acetaminophen concentration can vary

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) U.S. Food and Drug Administration officials are warning parents to carefully read dosing instructions for giving liquid acetaminophen for infants to avoid giving the wrong dose.

A less concentrated version of the over-the-counter pain reliever has arrived on shelves, and giving doses that are too small could be ineffective, while giving too much could result in serious side effects.

"Carefully read dosing instructions for infant acetaminophen."

Carol Holquist, director of FDA’s Division of Medical Error Prevention and Analysis, warned that consumers should be "very careful" in infant acetaminophen dosing.

Some manufacturers will now offer only the lower concentration to avoid confusion among strengths and prevent overdoses, but the stronger concentration is expected to remain on the market. Previously only the stronger concentration was available.

With both concentrations in circulation, parents should double check which concentration they have and carefully read the dosing instructions. They also should not depend on labels proclaiming the product is "new" to determine concentration since some medication with the old concentration may have that label.

Additionally, contact your pediatrician to ensure you are discussing the same concentration when establishing the appropriate dose, and use only the dosing device provided with the medication to avoid overdoses.

An April FDA report found that confusion among different concentrations of liquid acetaminophen for infants and children was leading to overdoses that made infants seriously ill, with some dying from liver failure.

Hoping to avoid those dosing errors, some manufacturers voluntarily changed the liquid acetaminophen marketed for infants from 80 mg per 0.8mL or 80 mg per 1 mL to be the same concentration as the liquid acetaminophen marketed for children—160 mg per 5mL.

However, the change is voluntary and both concentrations remain available at stores, and in the homes of some parents.

Parents are asked to remember that no specific dosing is provided for children under 2 years old, and a pediatrician should be consulted for dosing instructions.

Acetaminophen for infants is sold under brand names including Little Fevers Infant Fever/Pain Reliever, Pedia Care Fever Reducer Pain Reliever and Triaminic Infants’ Syrup Fever Reducer Pain Reliever. Store brands also are available.

Reviewed by: 
Review Date: 
December 23, 2011
Last Updated:
December 27, 2011