FDA.reportPublic FDA data

Extra Strength Gas Relief

Manufacturer
Hyvee Inc | Guardian Drug Company
Effective date
2026-03-27
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:51:49

Label at a glance#

ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

adults and children 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

do not use if any individual blister unit is broken or open store at room temperature avoid high humidity and excessive heat, above 40ºC (104ºF)

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
  • symptoms referred to as gas

WARNINGS

WARNINGS SECTION

.

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 children 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

  • do not use if any individual blister unit is broken or open
  • store at room temperature
  • avoid high humidity and excessive heat, above 40ºC (104ºF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HyVee®

Compare to the Active Ingredient in GAS-X®  EX Chewable

 

Extra Strength

 Gas Relief

Simethicone / Anti-Gas


Fast Relief of: 

  • Pressure
  • Bloating
  • Gas Distress

 

Cherry Flavor

18 CHEWABLE TABLETS

 134chr-18-hv.jpg134chr-18-hv.jpg

HyVee®

Compare to the Active Ingredient in GAS-X®  EX Chewable

Extra Strength

Gas Relief

Simethicone / Anti-Gas



Fast Relief of: 

  • Pressure
  • Bloating
  • Gas Distress

Cherry Flavor

18 CHEWABLE TABLETS

134chr-48-hv.jpg134chr-48-hv.jpg   


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN2
314221simethicone 125 MG Chewable TabletSCD2

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 Codehyvee.info/16h4uv134chr-18-hv.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-701-34Extra Strength Gas Relief4 in 1 CARTONTABLET, CHEWABLE42
42507-701-34Extra Strength Gas Relief9 in 1 BLISTER PACKTABLET, CHEWABLE92
42507-701-73Extra Strength Gas Relief2 in 1 CARTONTABLET, CHEWABLE22
42507-701-73Extra Strength Gas Relief9 in 1 BLISTER PACKTABLET, CHEWABLE92

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42507-70142507-701-73, 42507-701-34

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
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SORBITOL506T60A25RIACT
SUCROSEC151H8M554IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT

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
Extra Strength Gas ReliefSIMETHICONEHyvee Inc44ea37b1-8cd2-936d-e063-6394a90a2be72026-03-27WarningsExact identifier
ndc (package): 42507-701-73
ndc (package): 42507-701-34
ndc (product): 42507-701
ndc11 (package): 42507070134
ndc11 (package): 42507070173
spl id: 6ec0c564-958c-4fa2-aeb8-2e4e5a6fe7eb
spl set id: 44ea37b1-8cd2-936d-e063-6394a90a2be7

Reported adverse events (FAERS/openFDA)#

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