Gas-X

Manufacturer
Haleon US Holdings LLC
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:57:14

Label at a glance#

ProductGas-X Extra Strength Softgels
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure10 sections

Dosage and administration

• adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

• store at controlled room temperature 20-25ºC (68-77ºF) • protect from light, heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warning

WARNINGS 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: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20-25ºC (68-77ºF)
  • protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, hypromellose, mannitol, medium-chain triglycerides, peppermint oil, propylene glycol, purified water, sorbitol, soy lecithin, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-452-0051

Additional information

SPL UNCLASSIFIED SECTION

Gas-XExtra Strength Softgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

READ ALL PRODUCT INFORMATION BEFORE USING.

KEEP CARTON FOR IMPORTANT INFORMATION.

Gas-XExtra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste.

TAMPER EVIDENT FEATURE:

Do not use if blister is broken or damaged.

1-800-452-0051

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DOCTOR RECOMMENDED BRAND

Gas-X

SIMETHICONE 125 mg / ANTIGAS

RELIEVES GAS FAST

PRESSURE – BLOATING – DISCOMFORT

EXTRA STRENGTH

120 SoftGels

GasX ES Softgels 120ct
GasX ES Softgels 120ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
210299Gas-X Extra Strength 125 MG Oral CapsulePSN15
198852simethicone 125 MG Oral CapsulePSN15
210299simethicone 125 MG Oral Capsule [Gas-X]SBD15
198852simethicone 125 MG Oral CapsuleSCD15
198852dimethicone 125 MG Oral CapsuleSY15
210299Gas-X 125 MG Oral CapsuleSY15
210299Gas-X Extra Strength 125 MG Oral CapsuleSY15

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6275-01Gas-XExtra Strength Softgels120 in 1 CARTONCAPSULE, LIQUID FILLED12015
0067-6275-10Gas-XExtra Strength Softgels1 in 1 CARTONCAPSULE, LIQUID FILLED115
0067-6275-10Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-20Gas-XExtra Strength Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED215
0067-6275-20Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-30Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-30Gas-XExtra Strength Softgels3 in 1 CARTONCAPSULE, LIQUID FILLED315
0067-6275-50Gas-XExtra Strength Softgels5 in 1 CARTONCAPSULE, LIQUID FILLED515
0067-6275-50Gas-XExtra Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1015
0067-6275-72Gas-XExtra Strength Softgels6 in 1 CARTONCAPSULE, LIQUID FILLED615
0067-6275-72Gas-XExtra Strength Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1215
0067-6275-82Gas-XExtra Strength Softgels10 in 1 CARTONCAPSULE, LIQUID FILLED1015
0067-6275-82Gas-XExtra Strength Softgels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6275GAS-X EXTRA STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]15Current NDC, Legacy NDC, 13 package rows20250316_fa4a3b07-591b-4445-aa67-b17ba1e67d5c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6275-10EA - Each0067-6275ccc8f669-4f90-41c1-98e4-34f7aec94da312012-07-24
0067-6275-20EA - Each0067-6275220653e9-beb2-4d77-b763-d523a26130b612012-07-24
0067-6275-50EA - Each0067-627590721b79-fb28-4c10-a135-2e906776dc6c12012-07-24
0067-6275-72EA - Each0067-6275515a89ce-10b6-4704-ab16-de6cfefaca9212015-01-05
0067-6275-82EA - Each0067-6275154e27b1-14f2-470e-8039-fe814791321a12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O3
DIMETHICONEACTIVE MOIETY92RU3N3Y1O3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
GELATININACTIVE INGREDIENT2G86QN327L3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO3
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH3
SORBITANINACTIVE INGREDIENT6O92ICV9RU3
SORBITOLINACTIVE INGREDIENT506T60A25R3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0067-62750067-6275-30, 0067-6275-10, 0067-6275-20, 0067-6275-50, 0067-6275-72, 0067-6275-82, 0067-6275-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 416 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii+route
136 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii+route
80 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii+route
136 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RELIXIR / ORAL833.3 mgExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii+route
136 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route
144 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii+route
80 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route
136 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii+route
80 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii+route
136 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii+route
144 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii+route
80 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii+route
80 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii+route
136 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED PELLETS / ORAL3.32 mgExact identifier — unii+route
136 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii+route
80 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER, FOR SUSPENSION / ORAL12000 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii+route
136 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSYRUP / ORAL4370 mg/5mlExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE, FOR SUSPENSION / ORAL1.7 mgExact identifier — unii+route
136 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLIQUID / ORAL53460 mgExact identifier — unii+route
144 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii+route+dosage form
8 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii+route
144 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route
136 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii+route
80 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii+route
80 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCAPSULE / ORAL1111 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / ORAL6168 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii+route
144 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii+route
144 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii+route
80 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii+route
136 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, EXTENDED RELEASE / ORAL1472 mgExact identifier — unii+route
136 equally ranked IID candidates

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 Extra Strength SoftgelsSIMETHICONEHaleon US Holdings LLCfa4a3b07-591b-4445-aa67-b17ba1e67d5c2025-03-14WarningsExact identifier
ndc (package): 0067-6275-82
ndc (package): 0067-6275-72
ndc (package): 0067-6275-30
ndc (package): 0067-6275-50
ndc (package): 0067-6275-10
ndc (package): 0067-6275-01
ndc (package): 0067-6275-20
ndc (product): 0067-6275
ndc11 (package): 00067627550
ndc11 (package): 00067627520
ndc11 (package): 00067627582
ndc11 (package): 00067627530
ndc11 (package): 00067627572
ndc11 (package): 00067627510
ndc11 (package): 00067627501
spl id: 0f32f8eb-2579-4a26-99d5-a45c50bf5bdb
spl set id: fa4a3b07-591b-4445-aa67-b17ba1e67d5c

Reported adverse events (FAERS/openFDA)#

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