GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [SELECT BRAND]

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GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [SELECT BRAND]
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NDC 15127-157-08
Set ID f615124b-3696-4cd8-8b40-f2a7483aa3e2
Category HUMAN OTC DRUG LABEL
Packager Select Brand
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each tablet)

    simethicone 125 mg

  • Purpose

    Anti-gas

  • Uses

    relieves:

    • pressure
    • bloating
    • symptoms referred to as gas


  • Warnings

    Keep out of the 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

    Compare to the active ingredient of Gas-X Extra strength

    Extra strength

    Gas relief

    Simethicone 125 mg

    Relieves Gas

    Pressure

    Bloating

    Discomfort

    Cherry Creme

    18 chewable tablets

    box

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-157
    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)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code G134
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-157-082 in 1 CARTON
    19 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/02/2009
    Labeler - Select Brand (043562370)
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