FDA.reportPublic FDA data

Gas-X

Manufacturer
Haleon US Holdings LLC
Effective date
2025-07-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:07:28

Label at a glance#

ProductGas-X Total Relief Maximum Strength
Active ingredientCALCIUM CARBONATE, DIMETHICONE, UNSPECIFIED
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 300 mg do not store above 25°C (77°F) contains FD&C Yellow No. 5 (tartrazine) as a color additive

Label contents#

Full prescribing information#

Active ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 750 mg

Simethicone 250 mg

Purposes

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 300 mg
  • do not store above 25°C (77°F)
  • contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, beeswax, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, FD&C blue no.2 aluminum, FD&C red no. 40, FD&C red no. 40 aluminum lake, FD&C yellow no. 5 aluminum lake (tartrazine), maltodextrin, medium chain triglycerides, methylparaben, natural and artificial flavors, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac,
sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil

Questions or comments?

OTC - QUESTIONS SECTION

1-800-452-0051

Additional Information

SPL UNCLASSIFIED SECTION

Do not use if printed inner safety seal under cap is broken or missing.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DOCTOR RECOMMENDED BRAND

HALEON

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

218342 – Front Label

GAS-X\Gas-X Total Relief Chewy Bite 30ct - 0067-0118\Gas-X Max Strength Mixed Berries Chew Tabs 30 ct.jpg
GAS-X\Gas-X Total Relief Chewy Bite 30ct - 0067-0118\Gas-X Max Strength Mixed Berries Chew Tabs 30 ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1741562calcium carbonate 750 MG / simethicone 250 MG Chewable TabletPSN6
2590817Gas-X Total Relief 750 MG / 250 MG Chewable TabletPSN6
2590817calcium carbonate 750 MG / simethicone 250 MG Chewable Tablet [Gas-X Total Relief]SBD6
1741562calcium carbonate 750 MG / simethicone 250 MG Chewable TabletSCD6
2590817Gas-X Total Relief (calcium carbonate 750 MG / simethicone 250 MG) Chewable TabletSY6

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
0067-0118-01Gas-XTotal Relief Maximum Strength10 in 1 POUCHTABLET, CHEWABLE106
0067-0118-02Gas-XTotal Relief Maximum Strength1 in 1 CARTONTABLET, CHEWABLE16
0067-0118-02Gas-XTotal Relief Maximum Strength65 in 1 BOTTLETABLET, CHEWABLE656
0067-0118-03Gas-XTotal Relief Maximum Strength1 in 1 CARTONTABLET, CHEWABLE16
0067-0118-03Gas-XTotal Relief Maximum Strength30 in 1 BOTTLETABLET, CHEWABLE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-0118-01EA - Each0067-0118340e9250-5231-49d5-ba52-461f1b6b87fe12025-06-13
0067-0118-03EA - Each0067-011832d99d9f-bf51-47bc-9383-e4531389d4e212025-06-13

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-01180067-0118-03, 0067-0118-02, 0067-0118-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
YELLOW WAX2ZA36H0S2VIACT
CARNAUBA WAXR12CBM0EIZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
STARCH, CORNO8232NY3SJIACT
CORN SYRUP9G5L16BK6NIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
MALTODEXTRIN7CVR7L4A2DIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYLPARABENA2I8C7HI9TIACT
BUTYL ALCOHOL8PJ61P6TS3IACT
PHOSPHORIC ACIDE4GA8884NNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SUCROSEC151H8M554IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CORN OIL8470G57WFMIACT
CALCIUM CARBONATEH0G9379FGKACTIB
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

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 LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
ndc (package): 0067-0118-03
ndc (package): 0067-0118-02
ndc (package): 0067-0118-01
ndc (product): 0067-0118
ndc11 (package): 00067011801
ndc11 (package): 00067011803
ndc11 (package): 00067011802
spl id: 39fef47c-14de-b3b3-e063-6294a90afc1d
spl set id: edb0f11a-bdb7-484d-9257-09ff47b0fca4

Reported adverse events (FAERS/openFDA)#

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