Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

GAS-X REGULAR STRENGTH CHEWABLE PEPPERMINT- simethicone tablet, chewable 
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 80 mg

Purpose

Antigas

Uses

for the relief of

pressure and bloating commonly referred to as gas

Warnings

Keep Out of Reach of Children

Directions

adults: chew 1 or 2 tablets as needed after meals and at bedtime

do not exceed 6 tablets in a 24 hours except under the advice and supervision of a

physician

Other information

each tablet contains: calcium 30 mg

store at controlled room temperature 20-25°C (68-77°F)

protect from moisture

Inactive Ingredients

calcium carbonate, dextrose, flavors, maltodextrin, starch

Questions?

call 1-800-452-0051 24 hours a day, 7 days a week

Package/Label Principal Display Panel

Gas-X RS Peppermint Carton
GAS-X  REGULAR STRENGTH CHEWABLE PEPPERMINT
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0067-0116
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize14mm
FlavorPEPPERMINT (Peppermint Creme) Imprint Code Gas;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0067-0116-363 in 1 CARTON01/01/201206/30/2019
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 0067-0116-605 in 1 CARTON01/01/201206/30/2019
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/201206/30/2019
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 2/2018
Document Id: cd63a094-b1af-4203-a9f5-1c6491d0e500
Set id: 86804088-9f48-4a3b-9be3-17bad6e26a81
Version: 2
Effective Time: 20180220
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC