FOSTER AND THRIVE INFANTS GAS RELIEF- simethicone solution/ drops

Foster and Thrive infants Gas relief by

Drug Labeling and Warnings

Foster and Thrive infants Gas relief by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

Simethicone 20 mg

PURPOSE

Antigas

USE(S)

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

WARNINGS

.

WHEN USING THIS PRODUCT

do not exceed 12 doses per day

KEEP OUT OF REACH OF CHILDREN.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

• 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 mL
children over 2	over 24	0.6 mL

OTHER INFORMATION

store at room temperature

INACTIVE INGRADIENTS

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

QUESTIONS OR COMMENTS?

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

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

 

INGREDIENTS AND APPEARANCE

FOSTER AND THRIVE INFANTS GAS RELIEF 
simethicone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1078
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
Magnesium Aluminum silicate (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1078-1	1 in 1 CARTON	06/12/2023
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	06/12/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70677-1078)