OTC drugs will have better labels

May 1, 1999

Pharmaceutical Representative

Labels for over-the-counter medicines will soon be easier to read as a result of a new FDA regulation.

Labels for over-the-counter medicines will soon be easier to read as a result of a new Food and Drug Administration regulation, announced Vice President Al Gore and the secretary of the Department of Health and Human Services Donna Shalala.

The new labels, which pharmaceutical manufacturers will have to adopt within six years, must follow a standardized format that clearly shows dosage, ingredients and warnings (see example at left).

"All medicines have benefits and side effects," said Jane Henney, M.D., the commissioner of the Food and Drug Administration. "The improved label will make it easier for patients and consumers to select the appropriate over-the-counter product, and it will help them use that product more effectively."

The new labeling standards, titled "Drug Facts," will require active ingredients to be listed at the top, followed by uses, warnings, directions and inactive ingredients. The Food and Drug Administration has also recommended that manufacturers list their phone numbers on the labels so that consumers can call if they have questions.

Reflecting an awareness of an aging population, the new labeling will also require larger type sizes and other graphic features to improve readability.

Americans can expect to see the first new labels on products within two years, according to the agency. PR

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