FDA: Additional concentration of infant liquid acetaminophen available

January 13, 2012

In a safety announcement, FDA notified the public that that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores.

In a safety announcement, FDA notified the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores. Until now, only more concentrated versions of liquid acetaminophen have been available for infants. The higher concentrations of these older versions are 80 mg/0.8 mL and 80 mg/mL and continue to be available on store shelves, and in homes.

The availability of this new concentration follows the recommendation from a 2009 joint meeting of the FDA Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee that only 1 concentration of pediatric liquid acetaminophen be made available over the counter. Products with different concentrations can cause dosing confusion among parents and caregivers that may lead to unintentional overdoses in pediatric patients. 

In order to prevent possible dosing confusion between products with different concentrations of acetaminophen, many manufacturers voluntarily changed the higher concentrated liquid acetaminophen marketed for infants to make it the same lower concentration (160 mg/5 mL) as the product recently marketed for older children. The transition to the new concentration started earlier this year, however, products with varying strengths of liquid acetaminophen are still in stores and consumers' medicine cabinets.

“It will be up to manufacturers to determine whether they will stop making the 80-mg/0.8-mL and 80-mg/mL concentrations of liquid acetaminophen,” FDA noted. “Therefore, it is important for consumers to carefully read the Drug Facts label on the package to identify the strength, dosage, and directions for use for this product. Consumers should always check with a healthcare professional if they have any questions about medications they are using.”

FDA advises that healthcare professionals provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to any child under aged 12 years. In addition, the agency says the concentration of liquid acetaminophen should be included on a prescription because of the multiple products and concentrations that are available.

“Healthcare professionals should use their clinical judgment to recommend the most appropriate liquid acetaminophen product for children under the age of 12, and they should counsel caregivers on product differences,” the agency advised.

Healthcare professionals should report adverse events or medication errors involving over-the-counter infant acetaminophen products to the FDA MedWatch program here