CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR332]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 332 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

Subpart B - Active Ingredients

Sec. 332.10 Antiflatulent active ingredients.

Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling.

Sec. 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.

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Source: 39 FR 19877, June 4, 1974, unless otherwise noted.