[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: 21CFR331.11]

[Page 212-213]
 
                        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. 331.11  Listing of specific active ingredients.

    (a) Aluminum-containing active ingredients:
    (1) Basic aluminum carbonate gel.
    (2) Aluminum hydroxide (or as aluminum hydroxide-hexitol stabilized 
polymer, aluminum hydroxide-magnesium carbonate codried gel, aluminum 
hydroxide-magnesium trisilicate codried gel, aluminum-hydroxide sucrose 
powder hydrated).
    (3) Dihydroxyaluminum aminoacetate and dihydroxyaluminum aminoacetic 
acid.
    (4) Aluminum phosphate gel when used as part of an antacid 
combination product and contributing at least 25 percent of the total 
acid neutralizing capacity; maximum daily dosage limit is 8 grams.
    (5) Dihydroxyaluminum sodium carbonate.
    (b) Bicarbonate-containing active ingredients: Bicarbonate ion; 
maximum daily dosage limit 200 mEq. for persons up to 60 years old and 
100 mEq. for persons 60 years or older.
    (c) Bismuth-containing active ingredients:
    (1) Bismuth aluminate.
    (2) Bismuth carbonate.
    (3) Bismuth subcarbonate.
    (4) Bismuth subgallate.
    (5) Bismuth subnitrate.
    (d) Calcium-containing active ingredients: Calcium, as carbonate or 
phosphate; maximum daily dosage limit 160 mEq. calcium (e.g., 8 grams 
calcium carbonate).
    (e) Citrate-containing active ingredients: Citrate ion, as citric 
acid or salt; maximum daily dosage limit 8 grams.
    (f) Glycine (aminoacetic acid).
    (g) Magnesium-containing active ingredients:
    (1) Hydrate magnesium aluminate activated sulfate.
    (2) Magaldrate.
    (3) Magnesium aluminosilicates.
    (4) Magnesium carbonate.
    (5) Magnesium glycinate.
    (6) Magnesium hydroxide.
    (7) Magnesium oxide.
    (8) Magnesium trisilicate.
    (h) Milk solids, dried.
    (i) Phosphate-containing active ingredients:
    (1) Aluminum phosphate; maximum daily dosage limit 8 grams.
    (2) Mono or dibasic calcium salt; maximum daily dosage limit 2 
grams.
    (3) Tricalcium phosphate; maximum daily dosage limit 24 grams.
    (j) Potassium-containing active ingredients:
    (1) Potassium bicarbonate (or carbonate when used as a component of 
an effervescent preparation); maximum daily dosage limit 200 mEq. of 
bicarbonate ion for persons up to 60 years old and 100 mEq. of 
bicarbonate ion for persons 60 years or older.
    (2) Sodium potassium tartrate.

[[Page 213]]

    (k) Sodium-containing active ingredients:
    (1) Sodium bicarbonate (or carbonate when used as a component of an 
effervescent preparation); maximum daily dosage limit 200 mEq. of sodium 
for persons up to 60 years old and 100 mEq. of sodium for persons 60 
years or older, and 200 mEq. of bicarbonate ion for persons up to 60 
years old and 100 mEq. of bicarbonate ion for persons 60 years or older. 
That part of the warning required by Sec. 330.1(g), which states, ``Keep 
this and all drugs out of the reach of children'' is not required on a 
product which contains only sodium bicarbonate powder and which is 
intended primarily for other than drug uses.
    (2) Sodium potassium tartrate.
    (l) Silicates:
    (1) Magnesium aluminosilicates.
    (2) Magnesium trisilicate.
    (m) Tartrate-containing active ingredients. Tartaric acid or its 
salts; maximum daily dosage limit 200 mEq. (15 grams) of tartrate.

[39 FR 19874, June 4, 1974, as amended at 51 FR 27763, Aug. 1, 1986; 55 
FR 19859, May 11, 1990]