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Leading children's cough and cold medicine makers to label "do not use" if under 4 years of age

Washington, D.C. (October 7, 2008) — The following statement was issued by Linda Suydam, president of Consumer Healthcare Products Association:

Children’s over-the-counter (OTC) cough and cold medicines are safe and effective when used as directed, and the leading makers of these medicines are committed to working with the U.S. Food and Drug Administration (FDA) and pediatric experts to ensure that parents and caregivers have appropriate treatment choices for their children. 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 manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.

After consulting with FDA, the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral OTC pediatric cough and cold medicines to state “do not use” in children under four years of age; these modified labels will continue to provide dosing information for children four and older. In addition, for products containing certain antihistamines, manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy. Adult cough and cold medicines are not impacted by the label update.

Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral OTC pediatric cough and cold medicines with the new labels and packaging. As with other OTC labeling changes in the past, FDA has indicated it does not believe this labeling change warrants the removal of products with the existing labeling from store shelves during this time of transition.

Additionally, leading manufacturers already provide child-resistant packaging on all liquid pediatric cough and cold medicines to help reduce accidental ingestion and will provide dosing devices with each liquid medicine to help reduce dosing errors. These label updates and packaging enhancements reflect industry’s overall commitment to the continued safe and appropriate use of children’s oral OTC cough and cold medicines.

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:

  • Follow the dosing recommendations exactly and use the measuring device that comes with the medicine,
  • Do not give a medicine only intended for adults to a child,
  • 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.

Additionally, in consultation with FDA and outside experts, manufacturers are conducting studies to reaffirm the effectiveness of oral OTC pediatric cough and cold medicines through pharmacokinetic studies to confirm appropriate dosing schedules for children and to validate the efficacy of these medicines with current and appropriate clinical trial designs.

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

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