FDA.reportPublic FDA data

Gas-X

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:42

Label at a glance#

ProductGas-X Total Relief Maximum Strength
Active ingredientCALCIUM CARBONATE, DIMETHICONE
Label structure10 sections

Indications and 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

Dosage and administration

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

Storage and handling

each tablet contains: elemental calcium 295 mg store in a cool, dry place at no higher than 25°C (77°F)

Label contents#

Full prescribing information#

Active ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Antigas

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • each tablet contains:elemental calcium 295 mg
  • store in a cool, dry place at no higher than 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, corn syrup, dextrin, ethyl acetate, FD&C yellow 6, FD&C yellow 6 lake, flavor, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut origin)

Questions or comments?

OTC - QUESTIONS SECTION

1-855-328-5204

Additional Information

SPL UNCLASSIFIED SECTION

DO NOT USE IF POUCH IS OPEN OR TORN.

Dist. by: GSK CH,Warren, NJ 07059

Trademarks owned or licensed by GSK.

©2021 GSK or licensor.

Provides gas and heartburn relief

1001388

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW#1 DOCTOR RECOMMENDED BRAND

NDC 0067-0119-01

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

2 Chewable Tablets

1001388 – Front Pouch

Gas X Total Relief_2 ct pouch
Gas X Total Relief_2 ct pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1741562calcium carbonate 750 MG / simethicone 250 MG Chewable TabletPSN2
2590817Gas-X Total Relief 750 MG / 250 MG Chewable TabletPSN2
2590817calcium carbonate 750 MG / simethicone 250 MG Chewable Tablet [Gas-X Total Relief]SBD2
1741562calcium carbonate 750 MG / simethicone 250 MG Chewable TabletSCD2
2590817Gas-X Total Relief (calcium carbonate 750 MG / simethicone 250 MG) Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0119-01Gas-XTotal Relief Maximum Strength2 in 1 POUCHTABLET, CHEWABLE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0119GAS-X TOTAL RELIEF MAXIMUM STRENGTH (CALCIUM CARBONATE, SIMETHICONE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 1 package rows20240406_62fc0a91-c44f-4546-a472-c183a2d95486.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-01190067-0119-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
AMMONIA5138Q19F1XIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CORN SYRUP9G5L16BK6NIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
ETHYL ACETATE76845O8NMZIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ALUMINUM OXIDELMI26O6933IACT
ACACIA5C5403N26OIACT
ISOPROPYL ALCOHOLND2M416302IACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PHOSPHORIC ACIDE4GA8884NNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CORN OIL8470G57WFMIACT
CALCIUM CARBONATEH0G9379FGKACTIB
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLC62fc0a91-c44f-4546-a472-c183a2d954862024-04-05WarningsExact identifier
ndc (package): 0067-0119-01
ndc (product): 0067-0119
ndc11 (package): 00067011901
spl id: 155b17da-8661-a6be-e063-6394a90abece
spl set id: 62fc0a91-c44f-4546-a472-c183a2d95486

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.