Label: MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet

  • NDC Code(s): 51079-089-01, 51079-089-20, 51079-090-01, 51079-090-20
  • Packager: UDL Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/10

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  • DESCRIPTION

    Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:

    chemical structure

    C25H27CIN2•2HCI•H2O M.W. 481.89

    The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate.

    Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration.

    *Contains FD&C Yellow #5 (see PRECAUTIONS).

    Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, and stearic acid. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5.

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  • 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.

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  • INDICATIONS AND USAGE

    For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

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  • CONTRAINDICATIONS

    Meclizine hydrochloride is 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 the 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. Do not give to children under 12 years of age unless directed by a doctor.

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  • PRECAUTIONS

    The Meclizine Hydrochloride Tablets, 25 mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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

    Usage in Pregnancy: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 hydrochloride 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 hydrochloride, or any other medication should be used during pregnancy only if clearly necessary.

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  • ADVERSE REACTIONS

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

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  • DOSAGE AND ADMINISTRATION

    Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, 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.

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  • HOW SUPPLIED:

    Meclizine Hydrochloride Tablets, USP 12.5 mg - blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots. They are available as follows:

    NDC 51079-089-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

    Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are available as follows:

    NDC 51079-090-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each).

    Store at controlled room temperature 15° to 30°C (59° to 86°F).

    Manufactured by:
    Par Pharmaceutical Companies, Inc.
    Spring Valley, NY 10977

    Distributed by:
    UDL Laboratories, Inc.
    Rockford, IL 61103

    S-5278 R13
    3/10

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 12.5 mg

    NDC 51079-089-20

    MECLIZINE HYDROCHLORIDE
    TABLETS, USP
    12.5 mg

    100 Tablets (10 x 10)

    Each tablet contains:
    Meclizine HCl, USP . . . . . . 12.5 mg

    USUAL DOSAGE: Read Accompanying Literature.

    Store at controlled room temperature 15° to 30°C (59° to 86°F).

    Manufactured by:
    Par Pharmaceutical Companies, Inc.
    Spring Valley, NY 10977

    Rx only

    S-5276 R7

    Packaged and Distributed by:

    UDL LABORATORIES, INC.

    ROCKFORD, IL 61103

    This unit dose package is not child resistant.

    For institutional use only.

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

    This container provides light-resistance.

    See window for lot number and expiration date.

    Meclizine Hydrochloride 12.5 mg Tablets
    Unit Carton
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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL - 25 mg

    NDC 51079-090-20

    MECLIZINE HYDROCHLORIDE
    TABLETS, USP
    25 mg

    100 Tablets (10 x 10)

    Each tablet contains:
    Meclizine HCl, USP . . . . . . 25 mg

    USUAL DOSAGE: Read Accompanying Literature.

    CAUTION: This product contains FD&C Yellow
    No. 5 (tartrazine) which may cause allergic type
    reactions in certain susceptible individuals.

    Store at controlled room temperature 15° to 30°C (59° to 86°F).

    Manufactured by:
    Par Pharmaceutical Companies, Inc.
    Spring Valley, NY 10977

    Rx only

    S-5277 R7

    Packaged and Distributed by:

    UDL LABORATORIES, INC.

    ROCKFORD, IL 61103

    This unit dose package is not child resistant.

    For institutional use only.

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

    This container provides light-resistance.

    See window for lot number and expiration date.

    Meclizine Hydrochloride 25 mg Tablets
    Unit Carton
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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51079-090
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STARCH, CORN  
    STEARIC ACID  
    WATER  
    ISOPROPYL ALCOHOL  
    D&C YELLOW NO. 10  
    MAGNESIUM STEARATE  
    COLLOIDAL SILICON DIOXIDE  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 6mm
    Flavor Imprint Code Par;035
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51079-090-20 100 in 1 BOX, UNIT-DOSE
    1 NDC:51079-090-01 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087128 05/13/2011
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51079-089
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    FD&C BLUE NO. 1  
    WATER  
    ISOPROPYL ALCOHOL  
    STARCH, CORN  
    STEARIC ACID  
    MAGNESIUM STEARATE  
    COLLOIDAL SILICON DIOXIDE  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 5mm
    Flavor Imprint Code Par;034
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51079-089-20 100 in 1 BOX, UNIT-DOSE
    1 NDC:51079-089-01 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087127 05/13/2011
    Labeler - UDL Laboratories, Inc. (039615992)
    Registrant - UDL Laboratories, Inc. (039615992)
    Establishment
    Name Address ID/FEI Business Operations
    Par Pharmaceutical, Inc. 092733690 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    UDL Laboratories, Inc. 039615992 REPACK, RELABEL
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