# Antidiarrheal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph
> **Food and Drug Administration** · Final rule. · Published 2004-05-12 · Effective 2004-06-11 · 69 FR 26301
## Document
- **Document number:** 04-10750
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 26301
- **CFR reference:** 21 CFR 335
- **Publication date:** 2004-05-12
- **Effective date:** 2004-06-11
- **HHS docket:** Docket No. 1978N-036T
## Abstract

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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/05/12/04-10750/antidiarrheal-drug-products-for-over-the-counter-human-use-amendment-of-final-monograph)
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