Liquid Acetaminophen for Infants and Children Soon to be Same Concentration

Published on July 1, 2011 (AAP News):

All infant's and children’s liquid acetaminophen products soon will be available on store shelves in a single, uniform concentration - 160 mg/5 mL - for all children under 12 years of age. The industry-wide move will phase out the concentrated liquid drops for infants that, at 80 mg/0.8 mL, contain three times more medicine than the new standard concentration. The new uniform formulation is the same one currently found in Children’s Tylenol Suspension and its generic equivalents. The change is expected to help reduce dosing errors that can lead to accidental overdoses, with potential complications such as liver damage. More than 600 over-the-counter (OTC) and prescription products include acetaminophen. For parents, especially those with young children of varying ages, the different concentrations and dosing devices for the two acetaminophen concentrations has been confusing. Some parents may not have known there was a difference. As a result of the change, the 80 mg/0.8 mL concentration will be discontinued. Products in both formulations (the 80 mg/0.8 mL and the 160 mg/5mL) still may be found on store shelves - and in home medicine cabinets - during the transition period.

During the transition, health care professionals should remind parents to read product labels, paying special attention to the concentration in the product, and only use the dispensing device that accompanies the product. Health care personnel should verify with parents and caregivers their product’s concentration before advising on dosing directions.

Some of the newly formulated OTC acetaminophen products will begin arriving in stores in July. The new infant products coming out will be packaged with oral syringes that limit the amount of medicine that can be administered in a single dose. The transition of all of the products will continue into 2012.

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