Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ PART 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
/ Subpart B - Active Ingredients
Subpart B - Active Ingredients
§ 332.10 Antiflatulent active ingredients.
Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling.
§ 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.