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MECLIZINE HYDROCHLORIDE (JUBILANT CADISTA PHARMACEUTICALS, INC.)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BOTTLE (59746-121-06) Label Information
TABLET 1000 TABLET in 1 BOTTLE (59746-121-10) 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


  • PRINCIPAL DISPLAY PANEL

    100 Counts of 12.5mg Tablets

    NDC 59746-122-06

    Meclizine Hydrochloride Tablets, USP

    12.5 mg

    CADISTAâ„¢

    100 Tablets

    Rx Only

    Each tablet Contains 12.5 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].

    Manufactured by:
    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Rev.# 02/17

    TL 122

    100 Counts of 25mg Tablets

    NDC 59746-121-06

    Meclizine Hydrochloride Tablets, USP

    25 mg

    CADISTAâ„¢

    100 Tablets

    Rx Only

    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].

    Manufactured by:
    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Rev.# 02/17

    TL 121


  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE  
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-122
    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
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Fd&c Blue No. 1 (UNII: H3R47K3TBD)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code TL122
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59746-122-06 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    2 NDC:59746-122-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040659 06/04/2010
    MECLIZINE HYDROCHLORIDE  
    meclizine hydrocloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:59746-121-06 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    2 NDC:59746-121-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040659 06/04/2010
    Labeler - JUBILANT CADISTA PHARMACEUTICALS INC. (022490515)
    Establishment
    Name Address ID/FEI Business Operations
    JUBILANT CADISTA PHARMACEUTICALS INC. 022490515 manufacture(59746-121, 59746-122)