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

As the cough and cold season is upon us, the Consumer Healthcare Products Association issued a news release regarding a voluntary change in labeling by manufacturers of over the counter pediatric cough and cold medicines to state do not use in children under 4 years of age.

“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.”

The full statement can be found here:

http://www.chpa-info.org/10_07_08_PedCC.aspx.