Label: GAS RELIEF MINT FLAVOR- simethicone tablet, chewable

  • NDC Code(s): 68163-111-36
  • Packager: Raritan Pharmaceuticals 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 September 1, 2023

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Antigas

  • Uses

    Relieves:

    •
    bloating
    •
    pressure
    •
    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 at 1-800-222-1222.

  • Directions

    •
    thoroughly chew 1 to 2 tablets as needed after meals and at bedtime
    •
    do not exceed 4 tablets in 24 hours period except under the advice and supervision of a physician.
  • Other information

    •
    store at room temperature 20-25ºC (68-77ºF)
    •
    each tablets contains: calcium 60mg
  • Inactive ingredients

    dextrose, peppermint flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, tribasic calcium phosphate

  • Principal Display Panel

    NDC 68163-111-36

    DRx CHOICE

    Gas Relief

    Anti Gas/Simethicone 80 mg

    For fast relief of Bloating, Pressure & Gas Distress

    Mint Flavor

    Naturally and Artificially Flavored

    36 CHEWABLE TABLETS

    Manufactured by: Raritan Pharmaceuticals

    8 Joanna Court, East Brunswick, NJ 08816

    DRx Choice Simethicone 36 Chewable Tablets

    Simethicone 36 Chewable Tablets

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  MINT FLAVOR
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code RP111
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-111-3636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/17/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)
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