FDA.reportPublic FDA data

Extra Strength Gas Relief

Manufacturer
SAFEWAY
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:41:33

Label at a glance#

ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE, UNSPECIFIED
Label structure8 sections

Indications and uses

pressure, bloating and fullness commonly referred to as gas.

Dosage and administration

adults: chew 1 to 2 tablets as needed after meals and at bedtime do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician.

Storage and handling

each tablet contains: calcium 45 store at room temperature protect from excessive heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses for relief of

INDICATIONS & USAGE SECTION

  • 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:chew 1 to 2 tablets as needed after meals and at bedtime
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 45
  • store at room temperature
  • protect from excessive heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • *Compare to the active ingredient in Gas-X ®Extra Strength

Extra Strength

Gas Relief

Simethicone /Antigas

For Fast Relief of Pressure, Bloating & Discomfort

Cherry Creme Flavor

Natural and Artificially Flavored

18 CHEWABLE TABLETS

DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

*This product is not manufactured or distributed by GSK Consumer Healthcare Inc., the distributor of GAS-X ®Extra Strength.

Distributed by:

IMPORTANT:Keep this carton for future reference on full labeling.

Package Label for 18 Chewable Tablets

Extra Strength Gas Relief Simethicone 18 Chewable Tablets
Extra Strength Gas Relief Simethicone 18 Chewable Tablets

Package Label for 48 Chewable Tablets

SPL UNCLASSIFIED SECTION

Extra Strength Gas Relief Simethicone 48 Count
Extra Strength Gas Relief Simethicone 48 Count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN7
314221simethicone 125 MG Chewable TabletSCD7

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codealbtsn.com/ugtfkfjWC134CHR.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-110-18Extra Strength Gas Relief3 in 1 CARTONTABLET, CHEWABLE37
21130-110-18Extra Strength Gas Relief6 in 1 BLISTER PACKTABLET, CHEWABLE67
21130-110-48Extra Strength Gas Relief4 in 1 CARTONTABLET, CHEWABLE47
21130-110-48Extra Strength Gas Relief12 in 1 CARTONTABLET, CHEWABLE127

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-11021130-110-18, 21130-110-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 302S42T2808BIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUCRALOSE96K6UQ3ZD4IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-11-01full-release2026-06-01 00:32:53

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
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
ndc (package): 21130-110-18
ndc (package): 21130-110-48
ndc (product): 21130-110
ndc11 (package): 21130011018
ndc11 (package): 21130011048
spl id: 424a14de-b71e-3bfe-e063-6294a90a9422
spl set id: c8946bd2-6351-40e4-a139-d8214889bb4e

Reported adverse events (FAERS/openFDA)#

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