§ 331.10 21 CFR Ch. I (4–1–18 Edition) Subpart B—Active Ingredients (4) Bismuth subgallate. (5) Bismuth subnitrate. § 331.10 Antacid active ingredients. (d) Calcium-containing active ingre- (a) The active antacid ingredients of dients: Calcium, as carbonate or phos- the product consist of one or more of phate; maximum daily dosage limit 160 the ingredients permitted in § 331.11 mEq. calcium (e.g., 8 grams calcium within any maximum daily dosage carbonate). limit established, each ingredient is in- (e) Citrate-containing active ingredi- cluded at a level that contributes at ents: Citrate ion, as citric acid or salt; least 25 percent of the total acid neu- maximum daily dosage limit 8 grams. tralizing capacity of the product, and (f) Glycine (aminoacetic acid). the finished product contains at least 5 (g) Magnesium-containing active in- meq of acid neutralizing capacity as gredients: measured by the procedure provided in (1) Hydrate magnesium aluminate ac- the United States Pharmacopeia 23/Na- tivated sulfate. tional Formulary 18. The method es- (2) Magaldrate. tablished in § 331.20 shall be used to de- (3) Magnesium aluminosilicates. termine the percent contribution of (4) Magnesium carbonate. each antacid active ingredient. (5) Magnesium glycinate. (b) This section does not apply to an (6) Magnesium hydroxide. antacid ingredient specifically added as (7) Magnesium oxide. a corrective to prevent a laxative or (8) Magnesium trisilicate. constipating effect. (h) Milk solids, dried. (i) Phosphate-containing active in- [39 FR 19874, June 4, 1974, as amended at 61 FR 4822, Feb. 8, 1996] gredients: (1) Aluminum phosphate; maximum § 331.11 Listing of specific active in- daily dosage limit 8 grams. gredients. (2) Mono or dibasic calcium salt; (a) Aluminum-containing active in- maximum daily dosage limit 2 grams. gredients: (3) Tricalcium phosphate; maximum (1) Basic aluminum carbonate gel. daily dosage limit 24 grams. (2) Aluminum hydroxide (or as alu- (j) Potassium-containing active in- minum hydroxide-hexitol stabilized gredients: polymer, aluminum hydroxide-magne- (1) Potassium bicarbonate (or car- sium carbonate codried gel, aluminum bonate when used as a component of an hydroxide-magnesium trisilicate effervescent preparation); maximum codried gel, aluminum-hydroxide su- daily dosage limit 200 mEq. of bicar- crose powder hydrated). bonate ion for persons up to 60 years (3) Dihydroxyaluminum amino- old and 100 mEq. of bicarbonate ion for acetate and dihydroxyaluminum ami- persons 60 years or older. noacetic acid. (2) Sodium potassium tartrate. (4) Aluminum phosphate gel when (k) Sodium-containing active ingre- used as part of an antacid combination dients: product and contributing at least 25 (1) Sodium bicarbonate (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. 244 VerDate Sep<11>2014 11:29 Jun 12, 2018 Jkt 244074 PO 00000 Frm 00254 Fmt 8010 Sfmt 8010 Y:\SGML\244074.XXX 244074 nshattuck on DSK9F9SC42PROD with CFR Food and Drug Administration, HHS § 331.30 (2) Sodium potassium tartrate. Percent contribution = (Total mEq. (l) Silicates: Antacid Active Ingredient × 100)/(Total (1) Magnesium aluminosilicates. mEq. Antacid Product). (2) Magnesium trisilicate. [61 FR 4823, Feb. 8, 1996] (m) Tartrate-containing active ingre- dients. Tartaric acid or its salts; max- § 331.21 Test modifications. imum daily dosage limit 200 mEq. (15 grams) of tartrate. The formulation or mode of adminis- tration of certain products may require [39 FR 19874, June 4, 1974, as amended at 51 a modification of the United States FR 27763, Aug. 1, 1986; 55 FR 19859, May 11, Pharmacopeia 23/National Formulary 1990] 18 acid neutralizing capacity test. Any § 331.15 Combination with nonantacid proposed modification and the data to active ingredients. support it shall be submitted as a peti- tion under the rules established in (a) An antacid may contain any gen- § 10.30 of this chapter. All information erally recognized as safe and effective submitted will be subject to the disclo- nonantacid laxative ingredient to cor- sure rules in part 20 of this chapter. rect for constipation caused by the ant- acid. No labeling claim of the laxative [61 FR 4823, Feb. 8, 1996] effect may be used for such a product. (b) An antacid may contain any gen- Subpart D—Labeling erally recognized as safe and effective analgesic ingredient(s), if it is indi- § 331.30 Labeling of antacid products. cated for use solely for the concurrent symptoms involved, e.g., headache and (a) Statement of identity. The labeling acid indigestion, and is marketed in a of the product contains the established form intended for ingestion as a solu- name of the drug, if any, and identifies tion. the product as an ‘‘antacid.’’ (c) An antacid may contain any gen- (b) Indications. The labeling of the erally recognized as safe and effective product states, under the heading ‘‘In- antiflatulent ingredient if it is indi- dications,’’ the following: ‘‘For the re- cated for use solely for the concurrent lief of’’ (optional, any or all of the fol- symptoms of gas associated with heart- lowing:) ‘‘heartburn,’’ ‘‘sour stomach,’’ burn, sour stomach or acid indigestion. and/or ‘‘acid indigestion’’ (which may be followed by the optional statement:) Subpart C—Testing Procedures ‘‘and upset stomach associated with’’ (optional, as appropriate) ‘‘this symp- § 331.20 Determination of percent con- tom’’ or ‘‘these symptoms.’’ Other tribution of active ingredients. truthful and nonmisleading state- To determine the percent contribu- ments, describing only the indications tion of an antacid active ingredient, for use that have been established and place an accurately weighed amount of listed in this paragraph (b), may also the antacid active ingredient equal to be used, as provided in § 330.1(c)(2) of the amount present in a unit dose of this chapter, subject to the provisions the product into a 250-milliliter (mL) of section 502 of the act relating to beaker. If wetting is desired, add not misbranding and the prohibition in sec- more than 5 mL of alcohol (neutralized tion 301(d) of the act against the intro- to an apparent pH of 3.5), and mix to duction or delivery for introduction wet the sample thoroughly. Add 70 mL into interstate commerce of unap- of water, and mix on a magnetic stirrer proved new drugs in violation of sec- at 300 ±30 r.p.m. for 1 minute. Analyze tion 505(a) of the act. the acid neutralizing capacity of the (c) Warnings. The labeling of the sample according to the procedure pro- product contains the following warn- vided in the United States Pharma- ings, under the heading ‘‘Warnings’’, copeia 23/National Formulary 18 and which may be combined but not rear- calculate the percent contribution of ranged to eliminate duplicative words the antacid active ingredient in the or phrases if the resulting warning is total product as follows: clear and understandable: 245 VerDate Sep<11>2014 11:29 Jun 12, 2018 Jkt 244074 PO 00000 Frm 00255 Fmt 8010 Sfmt 8010 Y:\SGML\244074.XXX 244074 nshattuck on DSK9F9SC42PROD with CFR.