Stimulant
There is a specific FDA monograph for OTC stimulant drugs. This regulation outlines the ingredients and labeling requirements for these products. The only approved stimulant for OTC use is caffeine, which can help restore mental alertness or wakefulness during fatigue or drowsiness. The labeling must clearly state this purpose and include warnings about potential risks. Interestingly, the monograph prohibits combining caffeine with other stimulants like ephedrine due to safety concerns.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Caffeine | M011.10 (Part 340) |
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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