FDA.reportPublic FDA data

extra strength Gas Relief cherry creme

Manufacturer
Amerisource Bergen | Guardian Drug Company
Effective date
2025-01-08
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:21

Label at a glance#

Productextra strength Gas Relief cherry creme
Active ingredientDIMETHICONE
Label structure10 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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

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 THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Centre 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

OTHER SAFETY INFORMATION

  • 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.

Questions or comments?

SPL UNCLASSIFIED SECTION

1-(609) 860-2600 Mon. - Fri. 8:00 am - 4:30 pm.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 46122-811-08 

GOOD NEIGHBOR PHARMACY ®

Compare To Gas-X®    

EX Chewable active ingredient*

extra strength

Gas Relief

Anti-gas

fast relief of:

pressure, bloating

& symptoms of gas 



cherry creme

18 chewable tablets


134chr-18-gnp.jpg
134chr-18-gnp.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
46122-811-08extra strength Gas Relief cherry creme9 in 1 BLISTER PACKTABLET, CHEWABLE92
46122-811-08extra strength Gas Relief cherry creme2 in 1 CARTONTABLET, CHEWABLE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-811EXTRA STRENGTH GAS RELIEF CHERRY CREME (SIMETHICONE) TABLET, CHEWABLE [AMERISOURCE BERGEN]2Current NDC, 2 package rows20250110_1e8e8d85-10e2-1273-e063-6394a90a1558.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-811-08EA - Each46122-8117d3d95b8-710e-450e-83f9-6240fc62b6de12025-08-11

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
46122-81146122-811-08

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 cherry cremeSIMETHICONEAmerisource Bergen1e8e8d85-10e2-1273-e063-6394a90a15582025-01-08WarningsExact identifier
ndc (package): 46122-811-08
ndc (product): 46122-811
ndc11 (package): 46122081108
spl id: cd35a0da-817a-42b1-8e3c-1c63d7ef3694
spl set id: 1e8e8d85-10e2-1273-e063-6394a90a1558

Reported adverse events (FAERS/openFDA)#

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