MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]

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MECLIZINE HCL TABLET [PREFERRED PHARMACEUTICALS, INC.]
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NDC 68788-0118-2, 68788-0118-3, 68788-0118-5
Set ID dec9c5f6-929e-493d-ac4f-c24cf1f9e6ef
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active Ingredient

    (in each tablet)

    Meclizine HCl 25 mg 

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting, or dizziness due to motion sickness

  • WARNINGS

    Ask a doctor before use if you have

    •
    glaucoma
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    •
    you may get drowsy
    •
    avoid alcoholic drinks
    •
    alcohol, sedatives & tranquilizers may increase drowsiness
    •
    be careful when driving a motor vehicle or operating machinery
     
    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

    •
    take dose one hour before travel starts
    •
    tablets can be chewed or swallowed whole with water
    •
    adults & children 12 years and over: 1-2 tablets once daily
     
    children under 12 years: ask a doctor
  • Other Information

    •
    phenylketonurics: each tablet contains: phenylalanine 0.28mg
    •
    store at room temperature 15°-30°C (59°-86°F)
  • Inactive Ingredients

    aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

    How Supplied

    Bottle of 2 - 68788-0118-2

    Bottle of 25 - 68788-0118-5

    Bottle of 30 - 68788-0118-3

  • Questions or Comments

    Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Rugby® Duluth, Georgia 30097

    Repackaged by Preferred Pharmaceuticals, Inc.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Meclizine HCL

     

    COMPARE TO ACTIVE INGREDIENT IN BONINE

    Meclizine HCl 25 mg (ANTIEMETIC)

    Meclizine HCL 25mg Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-0118(NDC:0536-3990)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    Product Characteristics
    ColorREDScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-0118-22 in 1 BOTTLE; Type 0: Not a Combination Product12/13/2012
    2NDC:68788-0118-525 in 1 BOTTLE; Type 0: Not a Combination Product12/13/2012
    3NDC:68788-0118-330 in 1 BOTTLE; Type 0: Not a Combination Product12/13/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33612/13/2012
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022REPACK(68788-0118)
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