part_subject: "ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE"
subpart_code: "B"
subpart_subject: "Active Ingredients"
section_number: "331.10"
section_subject: "Antacid active ingredients."
cfr_reference: "21 CFR 331.10"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.