Executive Summary

SmithKline Beecham tells FDA that OTC 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. In a Jan. 28 letter discussing FDA's draft guidance on the use of a column format for required "Drug Facts" information, SmithKline says its suggestion would replace the need for the "Drug Facts (continued)" statement at the top of subsequent columns, "but still indicate the flow of the text to the consumer." CHPA and CTFA also have commented on the FDA guidance (1"The Tan Sheet" Feb. 14, p. 8)