PART 340—STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 53 FR 6105, Feb. 29, 1988, unless otherwise noted. Subpart A—General Provisions § 340.1 Scope. (a) An over-the-counter stimulant drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part and each of the general conditions established in § 330.1. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 340.3 Definition. As used in this part: Stimulant. Subpart B—Active Ingredient § 340.10 Stimulant active ingredient. The active ingredient of the product consists of caffeine when used within the dosage limits established in § 340.50(d). Subpart C—Labeling § 340.50 Labeling of stimulant drug products. (a) Statement of identity. (b) Indications. (c) 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.