Label: MECLIZINE HYDROCHLORIDE- meclizine tablet

  • NDC Code(s): 0378-5485-10, 0378-5485-77, 0378-5486-10, 0378-5486-77
  • Packager: Mylan Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2018

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  • DESCRIPTION

    Chemically, meclizine hydrochloride, USP is 1-(p-Chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate. The molecular weight is 481.88 g/mole.

    Meclizine Structural Formula

    Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg.

    Inert ingredients for the tablets are: anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose.

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  • CLINICAL PHARMACOLOGY

    Meclizine hydrochloride is an antihistamine that 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.

    Pharmacokinetics

    The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.

    Absorption

    Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at a median Tmax value of 3 hours post-dose (range: 1.5 to 6 hours) for the tablet dosage form.

    Distribution

    Drug distribution characteristics for meclizine in humans are unknown.

    Metabolism

    The metabolic fate of meclizine in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP2D6 was found to be the dominant enzyme for metabolism of meclizine.

    The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.

    Elimination

    Meclizine has a plasma elimination half-life of about 5-6 hours in humans.

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  • INDICATIONS AND USAGE

    Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.

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  • CONTRAINDICATIONS

    Meclizine hydrochloride tablets are contraindicated in individuals who have shown a previous hypersensitivity to it.

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  • 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.

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  • PRECAUTIONS

    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.

    Pregnancy Use

    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 meclizine 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.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when meclizine is administered to a nursing woman.

    Hepatic Impairment

    The effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. As meclizine undergoes metabolism, hepatic impairment may result in increased systemic exposure of the drug. Treatment with meclizine should be administered with caution in patients with hepatic impairment.

    Renal Impairment

    The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. Due to a potential for drug/metabolite accumulation, meclizine should be administered with caution in patients with renal impairment and in the elderly as renal function generally declines with age.

    Drug Interactions

    There may be increased CNS depression when meclizine is administered concurrently with other CNS depressants, including alcohol, tranquilizers, and sedatives (see WARNINGS).

    Based on in vitro evaluation, meclizine is metabolized by CYP2D6. Therefore there is a possibility for a drug interaction between meclizine and CYP2D6 inhibitors.

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  • ADVERSE REACTIONS

    Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

    To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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  • DOSAGE AND ADMINISTRATION

    For the treatment of vertigo associated with diseases affecting the vestibular system, the recommended dose is 25 to 100 mg daily, in divided dosage, depending upon clinical response.

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  • HOW SUPPLIED

    Meclizine Hydrochloride Tablets, USP are available containing 12.5 mg or 25 mg of meclizine hydrochloride, USP.

    The 12.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 12 on the other side. They are available as follows:

    NDC 0378-5485-77
    bottles of 90 tablets

    NDC 0378-5485-10
    bottles of 1000 tablets

    The 25 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and MCZ over 25 on the other side. They are available as follows:

    NDC 0378-5486-77
    bottles of 90 tablets

    NDC 0378-5486-10
    bottles of 1000 tablets

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

    Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Revised: 4/2018
    MECL:R4

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 12.5 mg

    NDC 0378-5485-77

    Meclizine
    Hydrochloride
    Tablets, USP
    12.5 mg

    Rx only      90 Tablets

    Each tablet contains:
    Meclizine
    hydrochloride, USP           12.5 mg

    Dispense in a tight, light-resistant
    container as defined in the USP
    using a child-resistant closure.

    Keep container tightly closed.

    Keep this and all medication
    out of the reach of children.

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

    Usual Dosage: See accompanying
    prescribing information.

    MOTION SICKNESS: 25 mg to 50 mg
    daily.

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Mylan.com

    RM5485MM1

    Meclizine Hydrochloride Tablets, USP 12.5 mg Bottle Label
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 25 mg

    NDC 0378-5486-77

    Meclizine
    Hydrochloride
    Tablets, USP
    25 mg

    Rx only      90 Tablets

    Each tablet contains:
    Meclizine
    hydrochloride, USP         25 mg

    Dispense in a tight, light-resistant
    container as defined in the USP
    using a child-resistant closure.

    Keep container tightly closed.

    Keep this and all medication
    out of the reach of children.

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

    Usual Dosage: See accompanying
    prescribing information.

    MOTION SICKNESS: 25 mg to 50 mg
    daily.

    Mylan Pharmaceuticals Inc.
    Morgantown, WV 26505 U.S.A.

    Mylan.com

    RM5486MM1

    Meclizine Hydrochloride Tablets, USP 25 mg Bottle Label
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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5485
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code M;MCZ;12
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-5485-77 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/19/2012 01/31/2020
    2 NDC:0378-5485-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/19/2012 01/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202640 09/19/2012 01/31/2020
    MECLIZINE HYDROCHLORIDE 
    meclizine tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-5486
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Color WHITE (white to off-white) Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code M;MCZ;25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0378-5486-77 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/19/2012 01/31/2020
    2 NDC:0378-5486-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/19/2012 01/31/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA202640 09/19/2012 01/31/2020
    Labeler - Mylan Pharmaceuticals Inc. (059295980)
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