EXTRA STRENGTH SIMETHICONE- simethicone capsule, liquid filled

Extra Strength Simethicone by

Drug Labeling and Warnings

Extra Strength Simethicone by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, Elysium Pharmaceuticals Ltd.. Drug facts, warnings, and ingredients follow.

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 20° to 25°C (68° to 776°F)
• protect from light, heat, and moisture

Inactive Ingredients

D&C Yellow 10, edible ink, FD&C blue 1, gelatin, glycerin, peppermint oil, polysorb,  purified water, titanium dioxide.

Questions?

Call toll-free 1-844-912-4012

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH SIMETHICONE 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-231
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
PEPPERMINT OIL (UNII: AV092KU4JH)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	911
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-231-72	72 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	04/01/2025

Labeler - Bi-Mart (027630078)

Registrant - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd.		915664486	manufacture(37835-231)