SIMETHICONE capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of pressure, bloating, and fullness, commonly referred to as gas.

Warnings

If pregnant or breast-feeding, ask a health Professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

Directions

• Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
• Do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information:

• Store at 15 to 30ºC (59 to 86ºF)
• Protect from light, heat, and moisture

Inactive Ingredients:

Peppermint oil, Gelatin 160 Bloom, Glycerol, Liquid Sorbitol 70%, Titanium dioxide, Allura Red, Brilliant Blue FCF, Quinoline Yellow FCF, Purified water.

Questions or Comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73581-302(NDC:72090-060)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
GELATIN (UNII: 2G86QN327L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73581-302-36	365 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	04/01/2026

Labeler - YYBA (006339772)

Registrant - YYBA (006339772)