GroundRules
21 CFR 331.10: Antacid active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 331—ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
- Subpart B—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.
Collected 2026-08-27T02:24:47Z. Source file · JSON