Label: SUNMARK GAS RELIEF- dimethicone 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 April 10, 2014

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Anti-gas

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    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 6 tablets per day unless directed by 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 40°C (104°F)
  • Inactive ingredients

    compressible sugar, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

  • Principal Display Panel

    Sunmark

    COMPARE TO GAS-X® ACTIVE INGREDIENT

    gas relief

    Regular Strength

    Fast relief of pressure, bloating & discomfort of gas

    SIMETHICONE 80 mg

    Peppermint creme

    36 Chewable TabletsPDP

    TEXT

  • INGREDIENTS AND APPEARANCE
    SUNMARK GAS RELIEF 
    dimethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-509
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    RAW SUGAR (UNII: 8M707QY5GH)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize14mm
    FlavorPEPPERMINTImprint Code GDC156
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-509-073 in 1 CARTON
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/10/2004
    Labeler - McKesson (177667227)
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