21 CFR 331.15
§ 331.15 Combination with nonantacid active ingredients.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 331.15, § 331.15 Combination with nonantacid active ingredients, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86497
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Full text
(a) An antacid may contain any generally recognized as safe and effective nonantacid laxative ingredient to correct for constipation caused by the antacid. No labeling claim of the laxative effect may be used for such a product.
(b) An antacid may contain any generally recognized as safe and effective analgesic ingredient(s), if it is indicated for use solely for the concurrent symptoms involved, e.g., headache and acid indigestion, and is marketed in a form intended for ingestion as a solution.
(c) An antacid may contain any generally recognized as safe and effective antiflatulent ingredient if it is indicated for use solely for the concurrent symptoms of gas associated with heartburn, sour stomach or acid indigestion.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.