[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR331.15]

[Page 220]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE--Table of Contents
 
                      Subpart B--Active Ingredients
 
Sec. 331.15  Combination with nonantacid active ingredients.

    (a) An antacid may contain any generally recognized as safe and 
effective nonantacid laxative ingredient to correct for constipation 
caused by the antacid. No labeling claim of the laxative effect may be 
used for such a product.
    (b) An antacid may contain any generally recognized as safe and 
effective analgesic ingredient(s), if it is indicated for use solely for 
the concurrent symptoms involved, e.g., headache and acid indigestion, 
and is marketed in a form intended for ingestion as a solution.
    (c) An antacid may contain any generally recognized as safe and 
effective antiflatulent ingredient if it is indicated for use solely for 
the concurrent symptoms of gas associated with heartburn, sour stomach 
or acid indigestion.