Antidiarrheal drug products for over-the-counter human use; amendment of final monograph. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) antidiarrheal drug products to include relief of travelers' diarrhea as an indication for products containing bismuth subsalicylate. Travelers' diarrhea occurs in travelers and is most commonly caused by an infectious agent. This final rule is part of FDA's ongoing review of OTC drug products.
D000930:Antidiarrheals / Q000145:classification* / Q000627:therapeutic use; D003967:Diarrhea / Q000188:drug therapy*; D004348:Drug Labeling / Q000145:classification / Q000331:legislation & jurisprudence; D006801:Humans; D007880:Legislation, Drug; D004366:Nonprescription Drugs / Q000145:classification* / Q000627:therapeutic use; D012459:Salicylates / Q000145:classification* / Q000627:therapeutic use; D014195:Travel; D014481:United States; D014486:United States Food and Drug Administration
D000930:Antidiarrheals; D004366:Nonprescription Drugs; D012459:Salicylates