[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR332.30]

[Page 216]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 332--ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 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), 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 Sec. 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.''
    (c) Exemption from the general accidental overdose warning. The 
labeling for antiflatulent drug products containing simethicone 
identified in Sec. 332.10 and antacid/antiflatulent combination drug 
products provided for in Sec. 332.15, containing the active ingredients 
identified in Sec. 331.11(a), (b), and (d) through (m) of this chapter 
are exempt from the requirement in Sec. 330.1(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 Sec. 330.1(g) of this chapter, which states, 
``Keep this and all drugs out of the reach of children.''

[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]