FOSTER AND THRIVE INFANTS GAS RELIEF - simethicone solution/ drops 
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Foster and Thrive infants Gas relief 520

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


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

1 FL. OZ. (30 mL) 100 Doses

F and T Gas Relief  drops 520

 

F and T Gas Relief Drops- Label -520

FOSTER AND THRIVE INFANTS GAS RELIEF 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1078
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Magnesium Aluminum silicate (UNII: 6M3P64V0NC)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1078-11 in 1 CARTON06/12/2023
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33206/12/2023
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70677-1078)

Revised: 6/2023
Document Id: 824c9dff-0a26-4710-a25b-39df631d6fa6
Set id: 824c9dff-0a26-4710-a25b-39df631d6fa6
Version: 1
Effective Time: 20230612
 
Strategic Sourcing Services LLC