OTC Industry Advocates for Expanding Children’s Dosing Instructions for Single-Ingredient Acetaminophen

Consumer Healthcare Products Association (CHPA)Jenni Terry, 202-429-9260

The Consumer Healthcare Products Association (CHPA) today asked the U.S. Food and Drug Administration (FDA) to take action to ensure that the millions of caretakers who use acetaminophen products in young children have access to convenient and accurate dosing information. Representing makers of over-the-counter (OTC) single-ingredient liquid acetaminophen medicines for children, CHPA submitted a requesting that the FDA publish a “statement of enforcement policy” permitting manufacturers of OTC single-ingredient liquid pediatric acetaminophen products to include dosing information for children ages 6 months to 2 years on the Drug Facts label of these medicines. While acetaminophen is approved for use in young children, the currently allowed labeling under tentative final monograph includes only “ask a doctor” in the dosing directions for children ages 6 months to 2 years.

“The peak of acetaminophen usage in children is for those ages 6 months to 23 months, yet the labeling of these products lacks instructions for this population,” said CHPA Vice President of Regulatory & Scientific Affairs Barbara A. Kochanowski, Ph.D.

“Young children can spike a fever at any time of the day or night, and to get dosing information for children under 2, caretakers must proactively seek out information from a healthcare provider rather than having the convenience of instructions printed on the Drug Facts label. Dosing instructions – whether they be gleaned from calls to healthcare providers, from photocopied materials distributed by pediatrician offices, or from charts found online -- may not be consistent in substance or format, leading to potential confusion regarding the proper dosage,” said Kochanowski. “Providing clear, consistent instructions directly on the label will help ensure that caretakers appropriately dose children under 2 years of age, potentially reducing the likelihood of dosing errors and dosing ‘guesses’ in the middle of the night.”

In , a joint FDA Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee that OTC single-ingredient liquid pediatric acetaminophen products include dosing information for children ages 6 months to 2 years.

In its citizen petition, CHPA requested permission for manufacturers to include pediatric dosing for children ages 6 months to 2 years on product labels moving forward, while rulemaking around the monograph is finalized. CHPA recommended a single, standardized age and weight-based chart – based on the researched and established dosing recommendations of multiple pediatric and primary care medical association treatment guidelines – which all manufacturers could adopt. This request follows a series of voluntary industry initiatives to facilitate appropriate use of OTC single-ingredient liquid acetaminophen use in children, including:

CHPA and its members are committed to providing parents with information and tools to help ensure that OTC medicines are used safely and appropriately in children. CHPA provides the following tips: