New Infants' Liquid Acetaminophen Products Hit Store Shelves

Patients May Ask About Concentration, Dosing Changes, Says FDA

December 23, 2011 12:45 am News Staff

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.

[Stock image of kids' Tylenol products]

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.