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OTC labeling

This article was originally published in The Rose Sheet

Executive Summary

Manufacturers should be allowed to start a heading or subheading on one column of a "Drug Facts" box and continue onto the next column by repeating the heading or subheading and adding "continued" in parentheses, SmithKline Beecham suggests to FDA. In a Jan. 28 letter commenting on the agency's draft guidance on the use of a column format for required "Drug Facts" information, SmithKline says its recommendation would replace the need for the "Drug Facts (continued)" statement at the top of subsequent boxes "but still indicate the flow of the text to the consumer." The Cosmetic Toiletry and Fragrance Association and Consumer Healthcare Products Association also have commented on the guidance (1"The Rose Sheet" Feb. 14, p. 8). Warner-Lambert echoes its support for a two-column format and points to discrepancies in sore throat warning labels in Jan. 31 comments

Manufacturers should be allowed to start a heading or subheading on one column of a "Drug Facts" box and continue onto the next column by repeating the heading or subheading and adding "continued" in parentheses, SmithKline Beecham suggests to FDA. In a Jan. 28 letter commenting on the agency's draft guidance on the use of a column format for required "Drug Facts" information, SmithKline says its recommendation would replace the need for the "Drug Facts (continued)" statement at the top of subsequent boxes "but still indicate the flow of the text to the consumer." The Cosmetic Toiletry and Fragrance Association and Consumer Healthcare Products Association also have commented on the guidance (1 (Also see "AHA Labeling Proposal Tops CFSAN's Cosmetics Priorities "A" List" - HBW Insight, 14 Feb, 2000.)). Warner-Lambert echoes its support for a two-column format and points to discrepancies in sore throat warning labels in Jan. 31 comments.

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