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Meclizine HCl (Preferred Pharmaceuticals, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 30 TABLET in 1 BOTTLE (68788-0118-3) Label Information

Complete Meclizine HCl Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0118(NDC:0536-3990)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score 2 pieces
    Shape ROUND Size 8mm
    Flavor RASPBERRY Imprint Code AP;115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-0118-2 2 in 1 BOTTLE; Type 0: Not a Combination Product 12/13/2012
    2 NDC:68788-0118-5 25 in 1 BOTTLE; Type 0: Not a Combination Product 12/13/2012
    3 NDC:68788-0118-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/13/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 12/13/2012
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-0118)