Label: FAMILY WELLNESS EXTRA STRENGTH GAS RELIEF CHERRY- simethicone tablet, chewable

  • NDC Code(s): 55319-134-34
  • Packager: Family Dollar Services, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 23, 2024

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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.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    Family WellnessTM

     

    COMPARE TO THE ACTIVE INGREDIENT IN GAS-X®  E-X CHEWABLE*


    EXTRA STRENGTH

     GAS RELIEF

    Simethicone 125 mg - Anti-Gas


    RELIEVES GAS FAST

    Pressure

    Bloating

    Gas Distress


    48 CHEWABLE TABLETS


    CHERRY FLAVOR 

    NDC 55319-134-34


    134chr-fw-48ct


  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS EXTRA STRENGTH GAS RELIEF CHERRY 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-134
    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:55319-134-344 in 1 CARTON02/23/2024
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart33202/23/2024
    Labeler - Family Dollar Services, Inc. (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(55319-134)