Statement from CHPA on Health Canada’s Label Updates to OTC Children’s Oral Cough and Cold Medicines

Washington, D.C. (December 18, 2008)—The following statement was issued by Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association, in response to Health Canada’s decision to update labels on children’s over-the-counter (OTC) oral cough and cold medicines:

Children’s over-the-counter cough and cold medicines continue to be safe and effective when used as directed. Today’s decision by Health Canada has no impact on medicines in the United States. While countries throughout the world have their own drug regulatory bodies charged with making decisions regarding medicine labeling within their own borders, the U.S. Food and Drug Administration (FDA) is in charge of this process here in the United States.

FDA has always taken a conservative approach when examining the risk-to-benefit ratio of medicines available in the United States. In October 2008, FDA indicated that its suggestion to U.S. manufacturers to re-label OTC children’s oral cough and cold medicines to read “do not use in children under age four” stems from a close look at all available data. In addition, the agency expressed its support of drug makers’ efforts to voluntarily modify directions advising parents not to use pediatric OTC oral cough and cold medicines in children under age four.

Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children. As a result, the leading U.S. manufacturers of OTC pediatric oral cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines. Additionally, and in cooperation with FDA and outside experts, U.S. manufacturers have committed to advance the current research, revalidate the efficacy of OTC pediatric oral cough and cold medicines, and confirm appropriate dosing schedules for children.

We also have expanded our national education program aimed at parents, caregivers, and healthcare professionals. The program focuses on educating parents and caregivers as follows:

  • Always read and follow the label,
  • Do not give OTC oral cough and cold medicines to children under 4 years of age,
  • Do not give more than the recommended dose and always use the dosing device that comes with the medicine,
  • Do not use two medicines at the same time that contain the same ingredients,
  • Prevent unsupervised ingestions by keeping all medicines out of the reach and sight of children,
  • Do not use antihistamine products to make a child sleepy, and
  • Consult a physician or healthcare professional with questions.

For more information about CHPA’s education campaign and more tips on safe dosing, visit

CHPA contact: Elizabeth Funderburk, 202.429.9260

CHPA is the 127-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.