Foster and Thrive infants Gas relief

Manufacturer
Strategic Sourcing Services LLC | Guardian Drug Company
Effective date
2024-12-13
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:43:20

Label at a glance#

ProductFoster and Thrive infants Gas relief
Active ingredientDIMETHICONE
Label structure11 sections

Dosage and administration

shake well before using all dosages may be repeated as needed, after meals and at bedtime fill enclosed dropper to recommended dosage level dispense liquid slowly into baby's mouth, toward the inner cheek may mix with 1 oz. of cool water, infant formula or other suitable liquids. clean dropper after each use and close the bottle to maintain child resistance  age (yr) weight (lb) dose  infants under 2  under 24 0.3...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

WARNINGS

WARNINGS SECTION

.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not exceed 12 doses per day

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 right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids.
  • clean dropper after each use and close the bottle to maintain child resistance

 age (yr)weight (lb)dose
 infants under 2 under 240.3 mL
 children over 2  over 240.6 mL

OTHER INFORMATION

OTHER SAFETY INFORMATION

store at room temperature

INACTIVE INGRADIENTS

INACTIVE INGREDIENT SECTION

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70677-1078-1

COMPARE TO MYLICON® NON-STAINING INFANTS' DROPS 

ACTIVE INGREDIENT* 

Foster and Thrive TM

INFANTS'

Gas Relief  Drops

Simethicone 20 mg

ANTIGAS

Relief of gas symptoms:

  • Pressure
  • Bloating
  • Non-staining Formula
  • Alcohol Free
  • Saccharin Free

1 FL. OZ. (30 mL) 100 Doses

F and T Gas Relief drops 520F and T Gas Relief drops 520F and T Gas Relief Drops- Label -520F and T Gas Relief Drops- Label -520

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1078-1Foster and Thrive infants Gas relief1 in 1 CARTONSOLUTION/ DROPS12
70677-1078-1Foster and Thrive infants Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1078FOSTER AND THRIVE INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20241215_824c9dff-0a26-4710-a25b-39df631d6fa6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1078-1ML - Milliliter70677-10780bed8343-b869-40f7-846c-a52c8b5ff77212023-09-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70677-107870677-1078-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 infants Gas reliefSIMETHICONEStrategic Sourcing Services LLC824c9dff-0a26-4710-a25b-39df631d6fa62024-12-13WarningsExact identifier
ndc (package): 70677-1078-1
ndc (product): 70677-1078
ndc11 (package): 70677107801
spl id: 645d778a-a011-472d-9b82-14474191cddc
spl set id: 824c9dff-0a26-4710-a25b-39df631d6fa6

Reported adverse events (FAERS/openFDA)#

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