Antidiarrheal Products
The U.S. Food and Drug Administration (FDA) has an over-the-counter (OTC) monograph that establishes safety and effectiveness standards for certain antidiarrheal ingredients. This monograph applies to products containing bismuth subsalicylate or kaolin, which help relieve diarrhea symptoms like frequent loose stools. The FDA considers these ingredients safe and effective for OTC use when used according to the monograph's dosing instructions.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Bismuth subsalicylate | M008.10 (Part 335) |
| Kaolin | M008.10 (Part 335) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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