EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

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

Warnings

Keep out of reach of children.

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 information

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

Inactive ingredients

FD & C blue #01, FD&C red #40,D&C yellow #10, gelatin, glycerin, peppermint oil, sorbitol solution, titanium dioxide

Questions or comments?

1-800-373-6981

Principal Display Panel

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Compare to the active ingredient in Extra Strength Gas-X®

Extra Strength Gas Relief
Simethicone 125 mg

Label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83059-0096
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	EG
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83059-0096-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	05/13/2028

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	05/13/2026

Labeler - Shield Pharmaceuticals Corp (118724924)