Envisioning new OTC labels

Potential changes to over-the-counter drug labeling came into clearer focus on Sept. 29 when the Food & Drug Administration held a public hearing soliciting ideas for a redesigned label.

The back panel of Pepcid AC 9;with its use of white space, horizontal rules, icons, bulleted copy and easy-to-see headings 9;is
The back panel of Pepcid AC 9;with its use of white space, horizontal rules, icons, bulleted copy and easy-to-see headings 9;is

A consistent label format with information such as directions, ingredients and warnings printed in the same order on all OTC products was suggested by the Nonprescription Drug Manufacturers Assn. (NDMA). The group-consisting of OTC medication producers and distributors-also suggested standardized, easy-to-follow introductory headings for warnings. It also seeks "plain English" language in place of the complicated and repetitive language currently required by FDA. With an eye towards making OTC labels more readable (and understandable), FDA is considering other graphic changes such as more white space; bulleting; horizontal or vertical rules; and icons or pictograms. A good example of a package incorporating these elements is Pepcid AC® Acid Controller(TM), produced by a joint venture of Johnson & Johnson and Merck, and introduced this summer. In fact, FDA considers the Pepcid AC label one example of what might be coming down the pike, FDA's Dr. Michael Weintraub tells PW. Weintraub, who's spearheading the redesign issue, says that the agency is moving quickly on a new regulation, which could come as early as year's end.

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