---
kind: "section"
citation: "21 C.F.R. § 332.30"
title: "21"
number: "332.30"
heading: "Labeling of antiflatulent drug products."
url: "https://uscodex.org/cfr/21/332.30"
---

# §332.30. Labeling of antiflatulent drug products.

- (a) **Statement of identity.** 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).”
- (b) **Indications.** The labeling of the product states, under the heading “Indications,” one or more of the phrases listed in this [paragraph (b)](#b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this [paragraph (b)](#b), may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=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.”
- (c) **Exemption from the general accidental overdose warning.** The labeling for antiflatulent drug products containing simethicone identified in [§ 332.10](/cfr/21/332.10.md) and antacid/antiflatulent combination drug products provided for in [§ 332.15](/cfr/21/332.15.md), containing the active ingredients identified in § [331.11(a)](/cfr/21/331.11.md?p=a), [(b)](/cfr/21/331.11.md?p=b), and [(d) through (m)](/cfr/21/331.11.md?p=d..m) of this chapter are exempt from the requirement in [§ 330.1(g)](/cfr/21/330.1.md?p=g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in [§ 330.1(g)](/cfr/21/330.1.md?p=g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”

## Notes

### Amendments

[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]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 39 FR 19877, June 4, 1974, unless otherwise noted.

### Amendments

[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]