[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: 21CFR331.10]

[Page 212]
 
                        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. 331.10  Antacid active ingredients.


    (a) The active antacid ingredients of the product consist of one or 
more of the ingredients permitted in Sec. 331.11 within any maximum 
daily dosage limit established, each ingredient is included at a level 
that contributes at least 25 percent of the total acid neutralizing 
capacity of the product, and the finished product contains at least 5 
meq of acid neutralizing capacity as measured by the procedure provided 
in the United States Pharmacopeia 23/National Formulary 18. The method 
established in Sec. 331.20 shall be used to determine the percent 
contribution of each antacid active ingredient.
    (b) This section does not apply to an antacid ingredient 
specifically added as a corrective to prevent a laxative or constipating 
effect.

[39 FR 19874, June 4, 1974, as amended at 61 FR 4822, Feb. 8, 1996]