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Meclizine Hydrochloride (Sandoz Inc)

Available Formats

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TABLET 100 TABLET in 1 BOTTLE (0781-1345-01) Label Information

Complete Meclizine Hydrochloride Information

  • Active ingredient

    Meclizine hydrochloride, USP 12.5 mg

    Meclizine hydrochloride, USP 25 mg


  • Purpose

    Antiemetic


  • Uses

    For prevention and treatment of these symptoms associated with motion sickness

    • nausea
    • vomiting
    • dizziness

  • Warnings

    Ask a doctor before use if you have
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are
    • giving this product to children under 12 years of age
    • taking sedatives or tranquilizers

    When using this product
    • you may get drowsy
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • 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 first dose one hour before starting activity
    • adults and children (12 years and over) 25 to 50 mg (2 to 4 tablets) once daily or as directed by a doctor
    • not more than 4 tablets in 24 hours

  • Other Information

    • Safety sealed: do not use if the imprinted bottle seal is open or torn.
    • Keep tightly closed

    • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

  • Inactive ingredients

    Croscarmellose sodium, FD&C blue #1 aluminum lake, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose and polysorbate 80


  • Questions or comments?

    1-800-525-8747

    Sandoz Inc.

    Princeton, NJ 08540

    10-2008M


  • 12.5 mg Label

    NDC 0781-1345-01

    Meclizine HCl

    Tablets, USP

    12.5 mg

    Antiemetic

    Relief of:

    Nausea Vomiting Dizziness

    100 Tablets

    SANDOZ

    Meclizine Hydrochloride 12.5 mg Label

  • 25 mg Label

    NDC 0781-1375-01

    Meclizine HCl

    Tablets, USP

    25 mg

    Antiemetic

    Relief of:

    Nausea Vomiting Dizziness

    100 Tablets

    SANDOZ

    Meclizine Hydrochloride 25 mg Label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0781-1345
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color BLUE Score score with uneven pieces
    Shape OVAL Size 5mm
    Flavor Imprint Code GG;141
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-1345-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 05/22/1989
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0781-1375
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color YELLOW Score score with uneven pieces
    Shape OVAL Size 6mm
    Flavor Imprint Code GG;261
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0781-1375-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 05/22/1989
    Labeler - Sandoz Inc (110342024)