21 CFR Part 338 — Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use

PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 54 FR 6826, Feb. 14, 1989, unless otherwise noted. Subpart A—General Provisions § 338.1 Scope. (a) An over-the-counter nighttime sleep-aid drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. § 338.3 Definition. As used in this part: Nighttime sleep-aid. Subpart B—Active Ingredients § 338.10 Nighttime sleep-aid active ingredients. The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in § 338.50(d): (a) Diphenhydramine hydrochloride. (b) Diphenhydramine citrate. Subpart C—Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. (b) Indications. (1) (“Helps you” or “Reduces time to”) “fall asleep if you have difficulty falling asleep.” (2) “For relief of occasional sleeplessness.” (3) “Helps to reduce difficulty falling asleep.” (c) Warnings. (1) “Do not give to children under 12 years of age.” (2) “If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.” (3) “Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland.” (4) “Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.” (5) “Do not use [bullet] 1 1 (d) Directions. (1) For products containing diphenhydramine hydrochloride identified in § 338.10(a). (2) For products containing diphenhydramine citrate identified in § 338.10(b). (e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section. [54 FR 6826, Feb. 14, 1989, as amended at 59 FR 16983, Apr. 11, 1994; 67 FR 72559, Dec. 6, 2002]

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