EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Extra Strength Gas Relief by

Drug Labeling and Warnings

Extra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (per each softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

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

Warnings

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 room temperature
• protect from light, heat, and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions or comments

1-866-467-2748

Principal Display Panel

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

Assured

Extra Strength

Gas Relief

SIMETHICONE, 125mg

ANTI-GAS

Relieves:

• Bloating
• Pressure
• Fullness
• Gas

  15 SOFTGELS
  

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.

Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

IMPORTANT: Keep this carton for future reference on full labeling.

DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-3113
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN (Opaque)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	PC2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-3113-5	1 in 1 CARTON	01/19/2018
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	01/19/2018

Labeler - Greenbrier International, Inc. (610322518)