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

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)
GELATIN (UNII: 2G86QN327L)
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)

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	10/28/2025
2	NDC: 35916-1938-2	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/28/2025
3	NDC: 35916-1938-3	2 in 1 BOX	01/16/2026
3		1500 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	10/28/2025

Labeler - Softgel Healthcare Pvt Ltd (676666501)