New Infants' Liquid Acetaminophen Products Hit Store Shelves

As cold and flu season ramps up, the FDA is again asking physicians to instruct parents to "read the label" as newly converted single-concentration OTC pediatric liquid acetaminophen products hit retailers' shelves.

In a Dec. 22 news release, the FDA said that the change in concentration for infant liquid acetaminophen products -- from the previous 80 mg /0.8 mL to a 160 mg/5 mL formulation -- could lead some parents to give infants less medication than intended and should "be especially noted if someone is accustomed to using the 80 mg /0.8 mL, or 80 mg/mL, concentration of liquid acetaminophen."

As previously reported, infant products -- such as Infants' Concentrated Tylenol Drops and its generic equivalents -- will eventually not be available in the 80 mg/0.8 mL formulation, instead switching to the 160 mg/5 mL formulation now used in Children's Tylenol Suspension and generic versions of that product. There will be a transition period, however, during which both formulations will be on store shelves.

The transition is consistent with a recommendation made in 2009 during a joint meeting of the FDA's Drug Safety and Risk Management, Nonprescription Drugs, and Anesthetic and Life Support Drugs advisory committees.

The new single-concentration infant products are packaged with specific dosing directions, oral syringes and flow restrictors to regulate dosage amounts, according to a news release from the Consumer Healthcare Products Association.

The AAFP supports a standardized approach for the use of milliliters as the preferred unit of measurement for liquid medications to prevent unintended medication overdoses in children.