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NDC 00067-0118-02 Gas-X 750; 250 mg/1; mg/1 Details

Gas-X 750; 250 mg/1; mg/1

Gas-X is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is CALCIUM CARBONATE; DIMETHICONE.

MedlinePlus Drug Summary

Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. It is available with or without a prescription. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00067-0118-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Calcium Carbonate

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Related Packages: 00067-0118-02
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone

Product Information

NDC	00067-0118
Product ID	0067-0118_edb0f11a-bdb7-484d-9257-09ff47b0fca4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Gas-X
Proprietary Name Suffix	Total Relief Maximum Strength
Non-Proprietary Name	Calcium carbonate, Simethicone
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	750; 250
Active Ingredient Units	mg/1; mg/1
Substance Name	CALCIUM CARBONATE; DIMETHICONE
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part331
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00067-0118-02 (00067011802)

Pricing Information	N/A
NDC Package Code	0067-0118-02
Billing NDC	00067011802
Package	1 BOTTLE in 1 CARTON (0067-0118-02) / 65 TABLET, CHEWABLE in 1 BOTTLE
Marketing Start Date	2022-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL edb0f11a-bdb7-484d-9257-09ff47b0fca4 Details

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.

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part331	02/03/2022

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