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New Labels for Over-the-Counter Medicines; Author Receives Plain Language Award

Consumers will soon find it easier to use the drugstore medications they use and give their families. HHS Secretary Donna E. Shalala announced on March 11 a final Food and Drug Administration regulation to provide new, easy-to -understand labeling on nonprescription drugs. Secretary Shalala made the announcement with Vice President Al Gore at the White House.

The regulation calls for a standardized format that will improve the labeling on drugs Americans use most,  nonprescription, or over-the-counter (OTC) drugs. By clearly showing a drug's ingredients, dose and warnings, the new labeling will make it easier for consumers to understand information about a drug's benefits and risks as well as its proper use.

Titled "Drug Facts," the new labeling makes it easier for consumers to identify active ingredients, which will be listed at the top, followed by uses, warnings, directions and inactive ingredients. The rule also sets minimum type sizes and other graphic features for the standardized format, including options for modifying the format for various package sizes and shapes.

Dr. Deborah Bowen, the author of the regulation, received a Plain Language Award from Vice President Al Gore for her use of plain language to communicate the substance of the regulation. The Vice President gives the awards to federal employees who fulfill the mandate of the Presidential Memorandum on Plain Language by writing or rewriting federal documents to make them easy for the public to understand and use.

In many cases, OTC drugs with the new labeling will begin appearing on the shelves within the next two years. All of the more than 100,000 OTC drugs will be required to adopt the new labeling within the next six years. FDA is developing a public education campaign to help consumers understand how the new labels can be used to learn more about OTC medications. This educational campaign will include print and other materials; these will be posted to this page as they are produced.

OTC Labeling: Questions and Answers

OTC Home Page

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Date updated: January 3, 2001

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