Label: QUALITY CHOICE EXTRA STRENGTH GAS RELIEF CHERRY- simethicone tablet, chewable

  • NDC Code(s): 63868-162-18
  • Packager: Chain Drug Marketing Association Inc.
  • 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 August 15, 2022

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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

    NDC 63868-162-18

    QC

    Quality Choice

    *Compare to the Active Ingredient in Extra Strength Gas-X®

    Extra Strength

     Gas Relief

    Antigas

    Simethicone 125 mg


    Relieves:

    Pressure

    Bloating

    Gas Distress


    Cherry Flavor 

    18 chewable tablets


    134chr-qc


  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE EXTRA STRENGTH GAS RELIEF CHERRY 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-162
    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:63868-162-182 in 1 CARTON08/15/2022
    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 FINALpart33208/15/2022
    Labeler - Chain Drug Marketing Association Inc. (011920774)