Code of Federal Regulations Title 21. Food and Drugs § 21.340.50 Labeling of stimulant drug products

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “altertness aid” or a “stimulant.”

(b) Indications. The labeling of the product states, under the heading “Indications,” the following:  “Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the Act relating to misbranding and the prohibition in section 301(d) of the Act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the Act.

(c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”:

(d) Directions. The labeling of the product contains the following information under the heading “Directions”:  Adults and children 12 years of age and over:  Oral dosage is 100 to 200 milligrams not more often than every 3 to 4 hours.