Drugmakers to Standardize Pediatric Liquid Acetaminophen Product Concentration

Although cold and flu season is still months away, physicians and parents should be aware that the manufacturers of single-ingredient OTC pediatric liquid acetaminophen products plan to convert all such products to a single concentration.

That means infant products -- such as Infants' Concentrated Tylenol Drops and its generic equivalents -- no longer will be available in an 80 mg/0.8 mL formulation. Instead, all pediatric liquid acetaminophen products will have the 160 mg/5 mL formulation used in Children's Tylenol Suspension and generic versions of that product.

"The purpose of this transition is to help minimize the potential for medication errors due to confusion between infants' and children's acetaminophen products having different concentrations," said McNeil Consumer Healthcare, the maker of Tylenol, in a May 4 letter to health care professionals.

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.

Infant products will be packaged with new dosing directions and oral syringes that limit the amount of product that can be administered in a single dose, according to a May 4 news release from the Consumer Healthcare Products Association, or CHPA.

CHPA said some markers of OTC pediatric acetaminophen products will begin shipping the reformulated infant products by summer.

That won't be the case with McNeil and Infants' Concentrated Tylenol Drops. McNeil recalled all lots of more than 40 formulations of its children's and infants' allergy and pain relief products -- including Tylenol products -- in April 2010 because of manufacturing deficiencies that could affect the products' quality, purity or potency. The company said in its recent letter to health care professionals that Tylenol infant drops are not expected to return to the market before fall.

CHPA said in its news release that consumers should be aware that during the transition, infant products with both the 80 mg/0.8 mL and 160 mg/5 mL formulations could be in stores and medicine cabinets at the same time.

"Consumers should always read and follow the label and pay particular attention to the concentration, especially when a healthcare provider gives dosing instructions," the association said.

McNeil emphasized that health care professionals also should be aware that both the old and new infant acetaminophen products will be on the market at the same time. The transition to the new formulation is expected to continue into next year.

"We ask your support in proactively discussing this change with parents and caregivers and ask that you and your staff always verify what product concentration parents and caregivers are using before providing dosing directions," McNeil said in its letter.

McNeil and CHPA both said consumers could continue to use pediatric acetaminophen products currently on the market as labeled.

Physicians with questions related to pediatric formulations of Tylenol may contact McNeil's health care professional line at (866) 948-6883.