[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR331.15]

[Page 219-220]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
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

[[Page 220]]

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.