Label: FOSTER AND THRIVE INFANTS GAS RELIEF- simethicone solution/ drops

  • NDC Code(s): 70677-1078-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

If you are a consumer or patient please visit this version.

  • 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 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:

    • 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- Label -520

  • INGREDIENTS AND APPEARANCE
    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 DrugM06/12/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70677-1078)