GAS-X EXTRA STRENGTH SOFTGELS- simethicone capsule, liquid filled

Gas-X by

Drug Labeling and Warnings

Gas-X by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125mg

Purpose

Antigas

Use

for the relief of

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

Warning

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

Inactive ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, sorbitan, sorbitol, titanium dioxide

Questions or comments?

call 1-800-452-0051

Principal Display Panel

#1 DOCTOR RECOMMENDED BRAND

NDC: 0067-6275-10

Gas-X®

SIMETHICONE 125 MG / ANTIGAS

RELIEVES GAS FAST

PRESSURE – BLOATING – DISCOMFORT

EXTRA STRENGTH

10 SOFTGELS

Gas-X® Extra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT FEATURE:

Gas-X® Extra Strength Softgels are sealed in blister packets. Use only of the individual seal is unbroken.

Gas-X® Extra Strength Softgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

1-800-452-0051

www.Gas-X.com

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies or its licensor. All rights reserved.

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INGREDIENTS AND APPEARANCE

GAS-X  EXTRA STRENGTH SOFTGELS
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6275
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PEPPERMINT OIL (UNII: AV092KU4JH)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	G;X
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-6275-30	3 in 1 CARTON	09/12/2011
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0067-6275-10	1 in 1 CARTON	09/12/2011
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0067-6275-20	2 in 1 CARTON	09/12/2011
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 0067-6275-50	5 in 1 CARTON	09/12/2011
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 0067-6275-72	6 in 1 CARTON	09/12/2011
5		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
6	NDC: 0067-6275-82	10 in 1 CARTON	09/12/2011	11/23/2019
6		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 0067-6275-01	120 in 1 CARTON; Type 0: Not a Combination Product	08/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	09/12/2011

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)