Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ PART 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
/ Subpart B - Active Ingredients / § 331.10 Antacid active ingredients.
§ 331.10 Antacid active ingredients.
(a) The active antacid ingredients of the product consist of one or more of the ingredients permitted in § 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 § 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.