EZ2GO (DIMETHICONE ) TABLET, CHEWABLE [VALLEY MEDICAL PRODUCTS,LLC]

EZ2GO (DIMETHICONE ) TABLET, CHEWABLE [VALLEY MEDICAL PRODUCTS,LLC]
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NDC 76470-012-12
Set ID c70a7a3d-8209-4a22-b54e-20bbbc9de8e8
Category HUMAN OTC DRUG LABEL
Packager Valley Medical Products,LLC
Generic Name
Product Class
Product Number
Application Number PART332
  • INACTIVE INGREDIENT

    Inactive Ingredients  compressible sugar, dextrose, flavor,

    magnesium stearate, maltodextirn, microcrystalline

    cellulose, sorbitol.

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    Simethicone 80 mg

  • PURPOSE

    Purpose

    Antigas

  • INDICATIONS & USAGE

    Uses - relieves -pressure - bloating

    -symptoms referred to as gas

  • KEEP OUT OF REACH OF CHILDREN

    Warnings  Keep out of the reach of children.

  • WARNINGS

    Warnings  Keep out of the reach of children. In case of overdose,

    get medical help or contact a Poison Control Center

    immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    -chew 2 to 4 tablets thoroughly as needed

    after meals and at bedtime

    -do not exceed 6 tablets per day

    unless directed by a physician

  • STORAGE AND HANDLING

    Other Information

    -do not use if inner seal is broken

    -store at room temperature

    -avoid high humidity and excessive heat,

    above 40 C (104 F)

  • QUESTIONS

    Qiestions or Comments?

    800-403-9832 or www.ez2go.com

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    EZ2GO 
    dimethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76470-012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg  in 80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code GPI;LB
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76470-012-1280 mg in 1 POUCH; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/01/2015
    Labeler - Valley Medical Products,LLC (969389407)

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