21 C.F.R. § 332.10 Antiflatulent active ingredients.
Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling.
CFR Subpart B
CFR Subpart B
in effect21 C.F.R. § 332.15 Combination with non-antiflatulent active ingredients.
An antiflatulent may contain any generally recognized as safe and effective antacid ingredient(s) if it is indicated for use solely for the concurrent symptoms of gas associated with heartburn, sour stomach or acid indigestion.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026