Traveler's diarrhea clarification
This article was originally published in The Tan Sheet
Executive Summary
FDA rejected Procter & Gamble's request for a traveler's diarrhea prevention claim for Pepto Bismol in April 1992 but is expected to include bismuth subsalicylate in the antidiarrheal final monograph as a Category I (safe and effective) ingredient for treatment of traveler's diarrhea ("The Tan Sheet" June 28, p. 21). McNeil's loperamide product Imodium A-D received NDA approval for a traveler's diarrhea treatment claim in November.