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

Washington, D.C. (August 19, 2013)—The Consumer Healthcare Products Association (CHPA) 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 citizen petition 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 May 2011, a joint FDA Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee unanimously recommended 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:

  • providing age-appropriate dosing devices in all packages (oral syringe for infants’ medicines and dosing cup for children’s medicines)
  • standardizing accompanying dosing devices with  milliliter (mL) dosing and consistent, easily visible measurements
  • converting infants’ and children’s acetaminophen to a single concentration across all brands (160mg/5mL) to standardize dosing and prevent dosing errors
  • adding flow restrictors to help make it more difficult for children to ingest large amounts of liquid in the event of an accidental unsupervised ingestion (curious young children getting in to medicine that was  left within reach)

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:

  • Always read and follow the label.
  • Only use the medicine that treats your child’s specific symptoms.
  • Never give an adult medicine to a child. Always follow the age and dosing instructions as specified on the medicine label.
  • Put medicines up and away and out of sight - EVERY time you use them.
  • Always lock the child safety cap completely every time you use a medicine.
  • Remind guests not to put medicines in purses, coats or places children can get into.
  • Keep the poison control helpline number handy: 800.222.1222.

Contact: Jenni Terry 202.429.9260

CHPA is the 130-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.