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
CaffeineM011.10 (Part 340)