Why are new directions appearing on children's over-the-counter cough and cold products?

Some makers of children's over-the-counter cough and cold products have started voluntarily changing labels on some medicines. This transition will result in new directions for parents and caregivers these products, indicating they should not be used for children under specific ages.

This is a voluntary label change. These products remain approved for use in children ages two and older. The United States Food and Drug Administration (FDA) is in the process of reviewing this issue.

For more information on why some makers of these products, nonetheless, are making these voluntary label changes, go to the website for the Consumer Healthcare Products Association (CHPA), available on-line at http://www.OTCsafety.org

Please contact a pharmacist, physician, or other health care professional if you have any questions about using cough and cold medicines. To address the needs of children of ages for which directions are not included on the product label, please contact your pediatrician.

For more information on FDA recommendations on over-the-counter cough and cold products for children, go to: http://www.fda.gov/consumer/updates/coughcold011708.html