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New Infants' Liquid Acetaminophen Products Hit Store Shelves
Patients May Ask About Concentration, Dosing Changes, Says FDA
By News Staff
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.