Food & Drug Administration. Called "Drug Facts," the new label is comparable to the nutrition label required on food packages. The drug's active ingredients are listed at the top, followed by uses, warnings, directions and inactive ingredients. Label information must appear in 6 pt or larger type size. The regulation includes options for modifying the format for various package sizes and shapes. The labeling requirement will affect more than 100ꯠ nonprescription drugs. The new label format is expected to appear on some drugs within the next two years, but all drugs must be in compliance within six years. FDA is developing a public education campaign to help consumers understand how to use the new label format to better understand the drugs they take. Vice President Al Gore presented the regulation's author, Dr. Deborah Bowen, with a Plain Language Award, given to federal employees who write or rewrite federal documents to make them easier for people to understand and use.
OTC drugs sport new labels
Over-the-counter drugs must contain a new standardized format label designed to make it easier for consumers to understand a drug's benefits, risks and proper use, according to a new regulation from the U.S.
Apr 30, 1999