Title 21 CFR reference

(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.

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.

As used in this part: Nighttime sleep-aid. A drug that is useful for the relief of occasional sleeplessness by individuals who have difficulty falling asleep.

Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as a “nighttime sleep-aid.” Indications.(b) The labeling of the product states, under the heading “Indications,” one or more of the phrases listed in this paragraph. 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) of this chapter, 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. (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.” Warnings.(c) The labeling of the product contains the following warnings under the heading “Warnings”: (1) “Do not give to children under 12 years of age.” (2) “If sleeplessness persists continuously for more than 2 weeks,…