Antiemetic Products
The U.S. Food and Drug Administration (FDA) has a specific monograph, M009, outlining regulations for over-the-counter (OTC) antiemetic drugs used to treat nausea and vomiting. This monograph establishes which ingredients are safe and effective for OTC use, including cyclizine hydrochloride, dimenhydrinate, diphenhydramine hydrochloride, and meclizine hydrochloride. It also sets dosing limits for each ingredient to ensure safety. Essentially, OTC antiemetic products must adhere to this monograph to be legally sold over the counter.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Cyclizine hydrochloride | M009.10 (Part 336) |
| Dimenhydrinate | M009.10 (Part 336) |
| Diphenhydramine hydrochloride | M009.10 (Part 336) |
| Meclizine hydrochloride | M009.10 (Part 336) |
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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