21 C.F.R. Subpart B—Active Ingredients
Title 21 - Food and Drugs
Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling. 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.
Title 21: Food and Drugs
PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 332.10 Antiflatulent active ingredients.
§ 332.15 Combination with non-antiflatulent active ingredients.
