GAS-X TOTAL RELIEF MAXIMUM STRENGTH- calcium carbonate, 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 ingredients (per tablet)

Calcium carbonate 750 mg

Simethicone 250 mg

Purpose

Antacid

Antigas

Uses

for the relief of

pressure, bloating, and fullness commonly referred to as gas
gas associated with heartburn, sour stomach, or acid indigestion
acid indigestion
heartburn
sour stomach
upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

do not exceed 2 tablets in 24 hours except under the advice and supervision of a doctor
do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

adults and children 12 years and older: chew 1 or 2 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing.
do not take for symptoms that persist for more than 2 weeks, unless advised by a doctor

Other information

each tablet contains: elemental calcium 295 mg
store in a cool, dry place at no higher than 25°C (77°F)
contains FD&C Yellow 5 Lake (tartrazine) as a color additive

Inactive ingredients

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, corn syrup, dextrin, ethyl acetate, FD&C red 40, FD&C red 40 lake, FD&C yellow 5 lake (tartrazine), FD&C yellow 6, FD&C yellow 6 lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac,

sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut origin)

Questions or comments?

1-855-328-5204

Additional Information

TAMPER EVIDENT FEATURE: Do not use if printed inner safety seal under cap is broken or missing.

Dist. by: GSK CH, Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

1001392

Principal Display Panel

NEW #1 DOCTOR RECOMMENDED BRAND

NDC 0067-0118-03

Gas-X

TOTAL RELIEF*

Simethicone / Antigas

Calcium Carbonate / Antacid

*Provides gas and heartburn relief

Fast Relief

√ GAS √ HEARTBURN √ BLOATING √ DISCOMFORT

MAXIMUM

STRENGTH

250 mg Simethicone

Mixed Berries

30 Chewable Tablets

1001392 – Front Carton

1001392_Gas X Total Relief_30 chewable tabs
GAS-X  TOTAL RELIEF MAXIMUM STRENGTH
calcium carbonate, simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0118
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CORN SYRUP (UNII: 9G5L16BK6N)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
ETHYL ACETATE (UNII: 76845O8NMZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ACACIA (UNII: 5C5403N26O)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SHELLAC (UNII: 46N107B71O)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITOL (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SUCROSE (UNII: C151H8M554)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CORN OIL (UNII: 8470G57WFM)  
Product Characteristics
ColorPURPLE (Red) Scoreno score
ShapeROUNDSize19mm
FlavorBERRY (Mixed Berries, Strawberry) Imprint Code GT
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-0118-031 in 1 CARTON02/03/2022
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-0118-021 in 1 CARTON02/03/2022
265 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33102/03/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2022
Document Id: edb0f11a-bdb7-484d-9257-09ff47b0fca4
Set id: edb0f11a-bdb7-484d-9257-09ff47b0fca4
Version: 1
Effective Time: 20220114
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC