Antidiarrheal rule

Executive Summary

Relief of travelers' diarrhea is included as an indication for bismuth subsalicylate products in the final monograph for OTC antidiarrheal drug products, effective June 11, FDA reports in the May 12 Federal Register. The condition is described as "a subset of diarrhea occurring in travelers that is most commonly caused by an infectious agent." The approval responds to requests made in response to the 1986 TFM on antidiarrheals (1"The Tan Sheet" April 21, 2003, p. 4). Web materials for Procter & Gamble's Pepto-Bismol already provide information on the condition...