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OTC "Drug Facts" labeling now in force

Thursday, May 16 marked the date that most over-the-counter (OTC) drug manufacturers were required to display the U.S. Food and Drug Administration's new, easier-to-read "Drug Facts" label on their products.

The OTC regulation, which the FDA finalized in March 1999, requires a standardized format for the labeling of the drugs Americans use most often.

Many manufacturers have voluntarily adapted the new OTC label well before the May 16 implementation date. In recent surveys, randomly selected categories of OTC drugs at a retail chain showed that nearly 75 percent of labels examined already displayed the "Drug Facts" label.

The new label format has been appearing -- voluntarily -- over the last two years. But now, most of the 100,000-plus OTC products marketed will be required to display the new labeling.

This major change in drug labeling will help consumers to select the most appropriate OTC medicines and to understand each drug's risks and benefits more easily.

Because the new "Drug Facts" label will transform how Americans take OTC drugs, more than 125 members of the National Council on Patient Information and Education (NCPIE) have mobilized to conduct a national "teach in" about the new label. This comprehensive campaign includes a newly expanded web site where consumers, health professionals, educators and the media can conduct individualized searches on any OTC drug by brand name and active ingredient.

Why is this change so important? The new "Drug Facts" label takes the guesswork out of label reading by making available user-friendly information about each drug's active ingredients uses, warnings and dosage directions. Patterned after the "Nutrition Facts" food label, the "Drug Facts" format was developed by the FDA after extensive research into how consumers use OTC drug labels.

Ultimately applying to over 100,000 OTC drugs, the new, simplified label has the potential to transform how Americans take nonprescription medicines, just as the simplified nutrition label has helped consumers choose healthier foods.

You can find out more about the new "Drug Facts" labeling at this special NCPIE website:

Launched in January 2002, Be MedWise is a public education initiative by the National Council on Patient Information and Education (NCPIE) a nonprofit coalition of over 125 consumer, government, patient advocacy and public health organizations. NCPIE serves as a trusted source of reliable information about the proper use of medicines, and Be MedWise seeks to promote a better understanding that over-the-counter (OTC) drug products are serious medicines and must be taken with care. Formed in 1982, NCPIE is a non-profit coalition working to improve health professional -- patient communication about the safe, appropriate use of medicines. More about NCPIE at:

Posted: May 2002