GAS-X EXTRA STRENGTH- simethicone gel
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Simethicone 125mg

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: 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 20-25o C (68-77o F)
•: 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, purified water, sorbitan, sorbitol, titanium dioxide

Questions or comments?

call 1-800-452-0051

Principal Display Panel

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GAS-X EXTRA STRENGTH
simethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0067-0134
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0067-0134-82	12 in 1 CARTON	05/18/2017	08/31/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0067-0134-72	6 in 1 CARTON	05/18/2017	03/31/2019
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	05/18/2017	03/31/2019

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

Revised: 5/2018

Document Id: fa35362f-432a-4bec-856f-34151402d1ff

Set id: 980362cf-1d15-4286-8ab8-bfeac7d34f4a

Version: 4

Effective Time: 20180508

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC.