Label: FOSTER AND THRIVE EXTRA STRENGTH GAS RELIEF CHERRY- simethicone tablet, chewable

  • NDC Code(s): 70677-1077-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 25, 2023

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  • ACTIVE INGREDIENT(in each tablet)

    Simethicone 125 mg

  • PURPOSE

    Anti-gas

  • USE(S)

    relieves:

    • pressure
    • bloating
    • symptoms referred to as gas
  • WARNINGS

    .

  • KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a poison control center immediately (1-800-222-1222).

  • DIRECTIONS

    • 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

    • 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

    D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose.

  • QUESTIONS OR COMMENTS?

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

  • 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 T

  • INGREDIENTS AND APPEARANCE
    FOSTER AND THRIVE EXTRA STRENGTH GAS RELIEF CHERRY 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1077
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize14mm
    FlavorCHERRYImprint Code G134
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1077-12 in 1 CARTON05/25/2023
    19 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33205/25/2023
    Labeler - Strategic Sourcing Services LLC (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(70677-1077)
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