Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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

46177349

46177349_Gas-X Extra Strength Softgels_10 ct.JPG
GAS-X  EXTRA STRENGTH SOFTGELS
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0067-6275
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code G;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0067-6275-303 in 1 CARTON09/12/2011
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 0067-6275-101 in 1 CARTON09/12/2011
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 0067-6275-202 in 1 CARTON09/12/2011
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC: 0067-6275-505 in 1 CARTON09/12/2011
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC: 0067-6275-726 in 1 CARTON09/12/2011
512 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC: 0067-6275-8210 in 1 CARTON09/12/2011
612 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC: 0067-6275-01120 in 1 CARTON; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33209/12/2011
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 2/2019
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC


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