GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [SAFEWAY]

GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [SAFEWAY]
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NDC 21130-135-73
Set ID 14a9fb00-707a-4b55-a060-82ad53a806e3
Category HUMAN OTC DRUG LABEL
Packager Safeway
Generic Name
Product Class
Product Number
Application Number PART332
  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Anti-gas

  • Uses

    relieves:

    • pressure
    • bloating
    • symptoms referred to as gas
  • KEEP OUT OF REACH OF CHILDREN

  • 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, D&C yellow 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

  • PDP

    *Compare to GAS-X®E-X Chewable active ingredient

    Signature Care

    Extra strength Gas Relief

    Simethicone 125 mg

    Anti-Gas

    Peppermint Flavor

    Relieves symptoms of gas discomfort, pressure and bloating

    18 chewable tablets

    Box

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-135
    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)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize16mm
    FlavorPEPPERMINTImprint Code G134
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-135-732 in 1 CARTON11/11/2015
    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 finalpart33211/11/2015
    Labeler - Safeway (009137209)
    Registrant - Guardian Drug Company (119210276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276manufacture(21130-135)

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