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In Brief: OTC label study

This article was originally published in The Tan Sheet

Executive Summary

OTC label study: Results from FDA's "Evaluation of Proposed OTC Label Format Comprehension," referred to as "Study A," are posted on the agency's Web site ( The 1,200 subject, mall-intercept study tested consumers' understanding and impression of mock OTC cough/cold and pain reliever labels. Participants viewed labels representative of both the current style and the "new" format outlined in FDA's Feb. 27 proposed rule on OTC label reform. FDA published an availability notice for its OTC Label Format Preference (Study B) in the Dec. 30 Federal Register ("The Tan Sheet" Jan. 12, pp. 3-5). The agency described plans for the studies in May ("The Tan Sheet" May 26, 1997, p. 1). FDA will use the results of the studies in preparing its final rule on OTC labeling...

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