GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON (SUNMARK)]

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GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [MCKESSON (SUNMARK)]
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NDC 49348-147-07
Set ID 3bed0156-9a65-42b8-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager STRATEGIC SOURCING SERVICES LLC
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Anti-Gas

  • Uses

    For the relief of pressure and bloating commonly referred to as gas

  • Warnings

    When using this product

    • do not take more than directed, except under the advice of a doctor

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children over 12 years, chew 1-2 tablets as needed after meals and at bedtime

      • chew thoroughly

      • do not exceed 6 tablets in 24 hours

    • children under 12 years, consult a doctor

  • Other information

    • store at room temperature, 15°C - 30°C (59˚F - 86˚F)
    • package not child resistant
  • Inactive ingredients

    dextrose, peppermint flavor, silica, sorbitol, stearic acid, talc, calcium phosphate.

  • package label

    SUN791sunmark

    compare to gas-x regular strength chewable tablets active ingredient*

    NDC 49348-147-07

    gas relief

    Regular Stength

    Soothing relief for pressure, bloating and gas symptoms

    SIMETHICONE 80 mg
    peppermint flavor

    36 CHEWABLE TABLETS

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-147
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code 44;137
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-147-071 in 1 CARTON04/01/2016
    136 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33204/01/2016
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
    Registrant - Geri-Care Pharmaceuticals, Corp (611196254)
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