Explore the full hierarchy of this title across chapters, subchapters, and parts.
Select a part from the tree to begin
Browse chapters and parts on the left to load sections
United States • Title 21 CFR • Part 332
This part of the CFR outlines the regulations for over-the-counter (OTC) antiflatulent products, defining their scope, active ingredients, labeling requirements, and exemptions.
An over-the-counter antiflatulent 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 following conditions and each of the general conditions established in § 330.1 of this chapter.
Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling.
An antiflatulent may contain any generally recognized as safe and effective antacid ingredient(s) if it is indicated for use solely for the concurrent symptoms of gas associated with heartburn, sour stomach or acid indigestion.
As used in this part: Antigas. A term that may be used interchangeably with the term antiflatulent. Neither term should be considered as describing the mechanism of action of the active ingredient contained in the product. [61 FR 8838, Mar. 5, 1996]
Statement of identity.(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antiflatulent,” “antigas,” or “antiflatulent (antigas).” Indications.(b) The labeling of the product states, under the heading “Indications,” one or more of the phrases listed in this paragraph (b), as appropriate. 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 Federal Food, Drug, and Cosmetic Act (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) (Select one of the following: “Alleviates or Relieves”) “the symptoms referred to as gas.” (2) (Select one of the following: “Alleviates” or “Relieves”) (select one or more of the following: “bloating,” “pressure,” “fullness,” or “stuffed feeling”) “commonly referred to as gas.” Exemption from the general…
(a) The labeling of the product provided to health professionals (but not to the general public) may contain as additional indications postoperative gas pain or for use in endoscopic examination. (b) Professional labeling for an antiflatulent-antacid combination may contain information allowed for health professionals for antacids and antiflatulents.
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.