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U.S. Department of Health and Human Services

About FDA

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March 11, 1999

Photo of a prescription drug label
FDA publishes a regulation mandating that labels of all over-the-counter drugs contain information in a standardized, consumer-friendly format. These "Drug Facts" labels, similar in format to the Nutrition Facts label for foods, are designed to provide easy-to-find information to help patients use the product safely and effectively.


FDA in 2006


The need for information about OTC medicines is growing: more than 700 medicine products available over-the-counter today use ingredients and dosages that were available only by prescription less than 30 years ago. There are more than 100,000 OTC products using about 1,000 active ingredients on the U.S market. The FDA offers a variety of resources to help consumers make good decisions about the OTC medicines they're using.



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