FDA.reportPublic FDA data

Foster and Thrive Extra Strength Gas Relief Cherry

Manufacturer
Strategic Sourcing Services LLC | Guardian Drug Company
Effective date
2024-12-13
Label type
Human OTC Drug Label
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:38

Label at a glance#

ProductFoster and Thrive Extra Strength Gas Relief Cherry
Active ingredientDIMETHICONE
Label structure10 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 (1-800-222-1222).

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.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70677-1077-1

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

Foster & Thrive TM

EXTRA STRENGTH

Gas Relief

Simethicone 125 mg

ANTIGAS

Relieves these gas symptoms:

  • Discomfort
  • Pressure
  • Bloating

CHERRY FLAVOR

18 CHEWABLE TABLETS

134CHR-F and T134CHR-F and T

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN3
314221simethicone 125 MG Chewable TabletSCD3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1077-1Foster and Thrive Extra Strength Gas Relief Cherry9 in 1 BLISTER PACKTABLET, CHEWABLE93
70677-1077-1Foster and Thrive Extra Strength Gas Relief Cherry2 in 1 CARTONTABLET, CHEWABLE23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1077FOSTER AND THRIVE EXTRA STRENGTH GAS RELIEF CHERRY (SIMETHICONE) TABLET, CHEWABLE [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20241215_e47374c8-05c1-4874-871b-e83d9b305bd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1077-1EA - Each70677-10778fc9569c-77e4-47fb-8588-5f30fd9b8a3f12023-09-05

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
70677-107770677-1077-1

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. 302S42T2808BIACT
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
Foster and Thrive Extra Strength Gas Relief CherrySIMETHICONEStrategic Sourcing Services LLCe47374c8-05c1-4874-871b-e83d9b305bd32024-12-13WarningsExact identifier
ndc (package): 70677-1077-1
ndc (product): 70677-1077
ndc11 (package): 70677107701
spl id: 5f6eca52-09d3-46a4-848e-4001ee910d99
spl set id: e47374c8-05c1-4874-871b-e83d9b305bd3

Reported adverse events (FAERS/openFDA)#

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