21 CFR 331.10
§ 331.10 Antacid active ingredients.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 331.10, § 331.10 Antacid active ingredients, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86495
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.