21 CFR Part 332 — Antiflatulent Products for Over-the-Counter Human Use

PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371. Source: 39 FR 19877, June 4, 1974, unless otherwise noted. Subpart A—General Provisions § 332.1 Scope. 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. § 332.3 Definitions. As used in this part: Antigas. [61 FR 8838, Mar. 5, 1996] Subpart B—Active Ingredients § 332.10 Antiflatulent active ingredients. Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling. § 332.15 Combination with non-antiflatulent active ingredients. 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. Subpart C—Labeling § 332.30 Labeling of antiflatulent drug products. (a) Statement of identity. (b) Indications. (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.” (c) Exemption from the general accidental overdose warning. [39 FR 19877, June 4, 1974, as amended at 40 FR 11719, Mar. 13, 1975; 51 FR 16266, May 1, 1986; 51 FR 27763, Aug. 1, 1986; 52 FR 7830, Mar. 13, 1987; 61 FR 8838, Mar. 5, 1996] § 332.31 Professional labeling. (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.

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