FDA.reportPublic FDA data

Extra Strength Gas Relief Tablets

Manufacturer
SAFEWAY
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
6
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

Dosage and administration

adults and Childrens 12 years and older: chew 1 to 2 tablets thoroughly as needed after meals and at bedtime do not exceed 4 tablets in a 24 hour period except under the advice and supervision of  a physician

Storage and handling

each tablet contains: calcium 45 mg store at room temperature protect from moisture

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-gas

USE(S)

INDICATIONS & USAGE SECTION

relieves:

  • Pressure, bloating and fullness commonly referred to as gas

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and Childrens 12 years and older:chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 4 tablets in a 24 hour period except under the advice and supervision of  a physician

Other Information

STORAGE AND HANDLING SECTION

  • each tablet contains:calcium 45 mg
  • store at room temperature
  • protect from moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Gas-X Extra Strength
NDC 21130-441-48
Extra strength
Gas Relief
Simethicone 125 mg/Anti-Gas
Fast Relief of Pressure, Bloating & Discomfort


Peppermint Flavor

Naturally and Artificially Flavored

18 Chewable Tablets

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

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


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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN6
314221simethicone 125 MG Chewable TabletSCD6

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
BarcodeEAN-130321130789536GTIN-13: 0321130789536
EAN-13: 0321130789536
GTIN-12: 321130789536
UPC-A: 321130789536
GTIN storage (14 digits): 00321130789536		134ppt.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-441-18Extra Strength Gas Relief2 in 1 CARTONTABLET, CHEWABLE26
21130-441-18Extra Strength Gas Relief9 in 1 BLISTER PACKTABLET, CHEWABLE96

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
21130-44121130-441-18

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 YELLOW NO. 1035SW5USQ3GIACT
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
52024-11-04full-release2026-06-01 00:33:59

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 ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
ndc (package): 21130-441-18
ndc (product): 21130-441
ndc11 (package): 21130044118
spl id: 424a2f1e-e3ba-4508-e063-6294a90a0e38
spl set id: cbbd43eb-1155-4e0d-bed4-32343f34b503

Reported adverse events (FAERS/openFDA)#

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