part_subject: "STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
subpart_code: "C"
subpart_subject: "Labeling"
section_number: "340.50"
section_subject: "Labeling of stimulant drug products."
cfr_reference: "21 CFR 340.50"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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”:
(1)“The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.”
(2)“For occasional use only. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to recur, consult a” (select one of the following: “physician” or “doctor”).
(3)“Do not give to children under 12 years of age.”
(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.