Cough Relief Ingredients Are Effective and Safe

CHPA says study on pediatric cough/cold medicines did not follow label directions for use

Washington, D.C. (July 7, 2004)—The Consumer Healthcare Products Association issued the following statement in response to an article published in the July issue of Pediatrics, “Effect of Dextromethorphan, Diphenhydramine, and Placebo on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents”:

“Over-the-counter, or OTC, cough/cold products provide therapeutic relief to millions of consumers of all ages each year. The United States Food and Drug Administration (FDA) and other regulatory agencies world-wide support the use of over–thecounter cough/cold products containing dextromethorphan (DM) and diphenhydramine (DPH) for providing relief of coughs and other symptoms associated with the common cold, and studies support the efficacy of these ingredients.”

CHPA notes that clinical studies usually have not included children or pregnant women, adding, “We applaud the effort of researchers to study the efficacy of these ingredients on cough relief in children. However, the conclusions of this study would need to be tested with a larger study population that uses the products according to the label directions. The study authors acknowledge that the reporting of children’s symptoms by their parents is subjective and imprecise, and the medicines in the study were not dispensed in doses according to label directions.”

Indeed, the study states:

It is important to note that this study evaluated the effect of the medications versus placebo using 1 dose administered on a single evening. It is possible that an effect could have been demonstrated with DPH or DM if children were given either multiple doses throughout the day or repeated nocturnal doses for several consecutive evenings.

OTC cough/cold products are effective for relieving the symptoms of colds, and because of their wide margin of safety, have very few side effects when used according to the label.

"Many of my patients find relief from OTC cough suppressants," said Dr. Paul Ehrlich, a New York City-based pediatric allergist and immunologist. "Cough and cold products containing dextromethorphan are safe and effective treatment options for children."

Contacts: Elizabeth Assey and Virginia Cox, 202.429.9260

CHPA is the 123-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplement products.