GAS-X TOTAL RELIEF MAXIMUM STRENGTH- calcium carbonate, simethicone tablet, chewable

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 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.

©2022 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

INGREDIENTS AND APPEARANCE

GAS-X  TOTAL RELIEF MAXIMUM STRENGTH
calcium carbonate, simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-0118
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	750 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE (Red)	Score	no score
Shape	ROUND	Size	19mm
Flavor	BERRY (Mixed Berries, Strawberry)	Imprint Code	GT
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-0118-03	1 in 1 CARTON	02/03/2022
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0067-0118-02	1 in 1 CARTON	02/03/2022
2		65 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0067-0118-01	10 in 1 POUCH; Type 0: Not a Combination Product	02/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M001	02/03/2022

Labeler - Haleon US Holdings LLC (079944263)