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Food and Drug Administration, HHS § 331.20

(4) Aluminum phosphate gel when (k) -containing active ingre- used as part of an combination dients: product and contributing at least 25 (1) (or carbonate percent of the total acid neutralizing when used as a component of an effer- capacity; maximum daily dosage limit vescent preparation); maximum daily is 8 grams. dosage limit 200 mEq. of sodium for (5) Dihydroxyaluminum sodium car- persons up to 60 years old and 100 mEq. bonate. of sodium for persons 60 years or older, (b) Bicarbonate-containing active in- and 200 mEq. of bicarbonate ion for per- gredients: Bicarbonate ion; maximum sons up to 60 years old and 100 mEq. of daily dosage limit 200 mEq. for persons bicarbonate ion for persons 60 years or up to 60 years old and 100 mEq. for per- older. That part of the warning re- sons 60 years or older. quired by § 330.1(g), which states, ‘‘Keep (c) Bismuth-containing active ingre- this and all drugs out of the reach of dients: children’’ is not required on a product (1) Bismuth aluminate. which contains only sodium bicarbon- (2) Bismuth carbonate. ate powder and which is intended pri- (3) Bismuth subcarbonate. marily for other than drug uses. (4) Bismuth subgallate. (2) Sodium potassium tartrate. (5) Bismuth subnitrate. (l) Silicates: (d) -containing active ingre- (1) aluminosilicates. dients: Calcium, as carbonate or phos- (2) Magnesium trisilicate. phate; maximum daily dosage limit 160 (m) Tartrate-containing active ingre- mEq. calcium (e.g., 8 grams calcium dients. Tartaric acid or its salts; max- carbonate). imum daily dosage limit 200 mEq. (15 (e) Citrate-containing active ingredi- grams) of tartrate. ents: Citrate ion, as citric acid or salt; [39 FR 19874, June 4, 1974, as amended at 51 maximum daily dosage limit 8 grams. FR 27763, Aug. 1, 1986; 55 FR 19859, May 11, (f) Glycine (aminoacetic acid). 1990] (g) Magnesium-containing active in- gredients: § 331.15 Combination with nonantacid (1) Hydrate magnesium aluminate ac- active ingredients. tivated sulfate. (a) An antacid may contain any gen- (2) Magaldrate. erally recognized as safe and effective (3) Magnesium aluminosilicates. nonantacid laxative ingredient to cor- (4) . rect for caused by the ant- (5) Magnesium glycinate. acid. No labeling claim of the laxative (6) . effect may be used for such a product. (7) . (b) An antacid may contain any gen- (8) Magnesium trisilicate. erally recognized as safe and effective (h) Milk solids, dried. analgesic ingredient(s), if it is indi- (i) Phosphate-containing active in- cated for use solely for the concurrent gredients: symptoms involved, e.g., headache and (1) Aluminum phosphate; maximum acid indigestion, and is marketed in a daily dosage limit 8 grams. form intended for ingestion as a solu- (2) Mono or dibasic calcium salt; tion. maximum daily dosage limit 2 grams. (c) An antacid may contain any gen- (3) Tricalcium phosphate; maximum erally recognized as safe and effective daily dosage limit 24 grams. antiflatulent ingredient if it is indi- (j) Potassium-containing active in- cated for use solely for the concurrent gredients: symptoms of gas associated with heart- (1) Potassium bicarbonate (or car- burn, sour stomach or acid indigestion. bonate when used as a component of an effervescent preparation); maximum Subpart C—Testing Procedures daily dosage limit 200 mEq. of bicar- bonate ion for persons up to 60 years § 331.20 Determination of percent con- old and 100 mEq. of bicarbonate ion for tribution of active ingredients. persons 60 years or older. To determine the percent contribu- (2) Sodium potassium tartrate. tion of an antacid active ingredient,

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