SIMETHICONE capsule, liquid filled

Simethicone by

Drug Labeling and Warnings

Simethicone by is a Otc medication manufactured, distributed, or labeled by Softgel Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each softgel)

Simethicone USP 125 mg

PURPOSE

Purpose

Antigas

INDICATIONS & USAGE

Use

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

WARNINGS

Warning

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• adults and children 12 years and older: 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 SAFETY INFORMATION

Other information

• store at controlled room temperature 20-25ºC (68-77ºF)
• protect from light, heat, and moisture

INACTIVE INGREDIENT

Inactive ingredients

D&C yellow no.10, FD&C blue no. 1, FD&C red no.40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

Principal Display Panel

Compare to Gas-X ® Extra Strength Active Ingredient*

NDC: 35916-1938-2

Simethicone Capsules USP, 125 mg

Simethicone 125 mg / Antigas (Relieves Gas Fast)

Pressure, Bloating, Discomfort

30 Softgels

Bulk Package Label

INGREDIENTS AND APPEARANCE

SIMETHICONE 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35916-1938
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEPPERMINT OIL (UNII: AV092KU4JH)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35916-1938-1	1000 in 1 BAG; Type 0: Not a Combination Product	04/05/2025
2	NDC: 35916-1938-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	04/05/2025

Labeler - Softgel Healthcare Pvt Ltd (675584180)