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MECLIZINE HYDROCHLORIDE (H.J. Harkins Company, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET 20 TABLET in 1 BOTTLE (52959-033-20) Label Information
TABLET 30 TABLET in 1 BOTTLE (52959-033-30) Label Information
TABLET 21 TABLET in 1 BOTTLE (52959-033-21) Label Information
TABLET 10 TABLET in 1 BOTTLE (52959-033-10) Label Information
TABLET 25 TABLET in 1 BOTTLE (52959-033-25) Label Information
TABLET 100 TABLET in 1 BOTTLE (52959-033-00) Label Information
TABLET 4 TABLET in 1 BOTTLE (52959-033-04) Label Information
TABLET 15 TABLET in 1 BOTTLE (52959-033-15) Label Information
TABLET 60 TABLET in 1 BOTTLE (52959-033-60) Label Information
TABLET 90 TABLET in 1 BOTTLE (52959-033-90) Label Information

Complete MECLIZINE HYDROCHLORIDE Information

  • DESCRIPTION

    Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

    Structure of Meclizine HCl

                              C25H27ClN2. 2HCl. H2O                                                                                        M.W. 481.88

    Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).


  • CLINICAL PHARMACOLOGY

    Meclizine Hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.


  • INDICATIONS AND USAGE

    For the management of nausea and vomiting, and dizziness associated with motion sickness.


  • CONTRAINDICATIONS

    Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.


  • WARNINGS

    Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

    Patients should avoid alcoholic beverages while taking this drug.

    Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma or enlargement of the prostate gland.


  • PRECAUTIONS

    PREGNANCY, Teratogenic Effects
    Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that medicine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary. 

    Pediatric Use
    Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.


  • ADVERSE REACTIONS

    Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.


  • DOSAGE AND ADMINISTRATION

    Motion Sickness
    The initial dose of 25 to 50 mg of Meclizine HCI should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.


  • HOW SUPPLIED

    Meclizine HCI Tablets, USP are available in the following strengths and package sizes:

    12.5 mg (Blue, oval-shaped, scored, debossed with TL122)

    Bottles of 100           NDC 59746-122-06
    Bottles of 1000         NDC 59746-122-10

    25 mg (Yellow, oval-shaped, scored, debossed with TL121)

    Bottles of 100            NDC 59746-121-06
    Bottles of 1000          NDC 59746-121-10

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

    Manufactured By:

    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA.

    Revised 03/11

    Repacked by:
    H.J. Harkins Company, Inc.
    513 Sandydale Drive
    Nipomo, CA 93444


  • PRINCIPAL DISPLAY PANEL

    100 Counts of 25mg Tablets

    NDC 59746-121-010

    CADISTA

    Meclizine Hydrochloride Tablets, USP

    25 mg

    Rx only

    1000 Tablets

    Each tablet contains 25 mg of meclizine HCl.

    DOSAGE AND USE 
    See accompanying prescribing information

    MOTION SICKNESS:
    25 mg to 50 mg daily.

    Dispense in tight, light-resistant containers (USP).

    Store at 20-25°C (68-77°F)
    [See USP Controlled Room temperature].

    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA


    Repacked by:

    H.J. Harkins Company, Inc.

    Nipomo, CA 93444
    Rev.# 03/11

    Lot No.:

    Exp Date:


  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE  
    meclizine hydrocloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-033(NDC:59746-121)
    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
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    D&c Yellow No. 10 (UNII: 35SW5USQ3G)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape OVAL Size 13mm
    Flavor Imprint Code TL121
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52959-033-04 4 in 1 BOTTLE
    2 NDC:52959-033-10 10 in 1 BOTTLE
    3 NDC:52959-033-15 15 in 1 BOTTLE
    4 NDC:52959-033-20 20 in 1 BOTTLE
    5 NDC:52959-033-21 21 in 1 BOTTLE
    6 NDC:52959-033-25 25 in 1 BOTTLE
    7 NDC:52959-033-30 30 in 1 BOTTLE
    8 NDC:52959-033-60 60 in 1 BOTTLE
    9 NDC:52959-033-90 90 in 1 BOTTLE
    10 NDC:52959-033-00 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040659 06/04/2010
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Establishment
    Name Address ID/FEI Business Operations
    JUBILANT CADISTA PHARMACEUTICALS, INC. 022490515 MANUFACTURE