Label: GAS RELIEF- simethicone tablet, chewable

  • 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 September 28, 2018

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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

    Topcare
    NDC 36800-122-73
    COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*
    EXTRA STRENGTH
    Gas
    Relief
    ANTI-GAS/SIMETHICONE, 125 mg

    FAST RELIEF OF:

    • Bloating
    • Pressure
    • Discomfort of Gas

    CHERRY FLAVOR

    18 CHEWABLE TABLETS

    75

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-122
    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:36800-122-733 in 1 CARTON09/28/2018
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33209/28/2018
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(36800-122)
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