Statement from the Consumer Healthcare Products Association (CHPA) on FDA’s Final Rule Regarding Over-the-Counter (OTC) Internal Analgesics Labeling

Labels are changing for OTC medications containing acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium

Washington, D.C. (April 28, 2009)—The following is a statement from Barbara Kochanowski, Ph.D., vice president, regulatory affairs, CHPA, regarding the U.S. Food and Drug Administration’s (FDA’s) final rule concerning updates to Drug Facts labels for pain relievers and fever reducers:

“CHPA member companies are committed to ensuring that their medicines’ labeling is the most comprehensive and comprehensible possible. Providing clear and useful information on labels is the best way to communicate directly to consumers about how to safely and effectively use medicines, and therefore is of utmost importance to medicine makers.

“CHPA member companies voluntarily have begun implementing many of the label changes included in the final rule that will publish April 29, 2009, well ahead of the April 28, 2010, implementation deadline. These label changes are designed to provide consumers with a greater understanding of some of the risks that could be associated with the misuse of these medications.

“Our top priority is the safe and effective use of our products and we will continue to work with the U.S. Food and Drug Administration to ensure that consumers have the information they need on Drug Facts labels and elsewhere to get the most benefit from OTC medicines. In addition, guidelines, tips, and resources on safe OTC medicine use are available in English and Spanish at the nonprofit CHPA Educational Foundation, found online at”

Contacts: Virginia Cox and Mimi Pappas, 202.429.9260

CHPA is the 128-year-old-trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.