FDA.reportPublic FDA data

Extra Strength Gas Relief Cherry

Manufacturer
Harris Teeter, LLC | Guardian Drug Company
Effective date
2025-02-04
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:22

Label at a glance#

ProductExtra Strength Gas Relief Cherry
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

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

  • 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

Harris Teeter™

NDC 69256-134-73


EXTRA STRENGTH

 GAS RELIEF


Anti-Gas . Simethicone 125 mg 


Relieves: 

Pressure

Bloating

Gas Distress

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


Cherry Flavor

18 CHEWABLE TABLETS

 

134chr-18-ht.jpg134chr-18-ht.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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-134-73Extra Strength Gas Relief Cherry2 in 1 CARTONTABLET, CHEWABLE22
69256-134-73Extra Strength Gas Relief Cherry9 in 1 BLISTER PACKTABLET, CHEWABLE92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-134EXTRA STRENGTH GAS RELIEF CHERRY (SIMETHICONE) TABLET, CHEWABLE [HARRIS TEETER, LLC]2Current NDC, 2 package rows20250206_2bd9ebda-520c-691a-e063-6294a90af7d3.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-13469256-134-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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

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 Relief CherrySIMETHICONEHarris Teeter, LLC2bd9ebda-520c-691a-e063-6294a90af7d32025-02-04WarningsExact identifier
ndc (package): 69256-134-73
ndc (product): 69256-134
ndc11 (package): 69256013473
spl id: d21c0054-57f5-4a73-8bfc-c403d447e2fe
spl set id: 2bd9ebda-520c-691a-e063-6294a90af7d3

Reported adverse events (FAERS/openFDA)#

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