"After consulting with the FDA, the leading manufacturers of these medicines are voluntarily transitioning the labeling on oral over-the-counter pediatric cough and cold medicines to state 'do not use' in children under four years of age," noted the statement, which also included the following points:
• These modified labels will continue to provide dosing information for children four and older. In addition, for products containing antihistamines, manufacturers are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy.
• Children's 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 FDA and pediatric experts to ensure that parents and caregivers have appropriate treatment choices for their children.
• 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. For more information, visit www.OTCsafety.org. [HCP]
--Jim Butschli
CHPA issues voluntary pediatric cough and cold label updates
"Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral pediatric cough and cold medicines with new labels and packaging. As with other OTC [over-the-counter] labeling changes in the past, FDA [U.S. Food and Drug Administration] 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." These remarks stem from an October statement issued by Linda Suydam, president of the Consumer Healthcare Products Assn.
Dec 15, 2008
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