Label: MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet

  • NDC Code(s): 0591-0802-01, 0591-0803-01, 0591-0803-10
  • Packager: Watson Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status:

Drug Label Information

Updated 03/06

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  • DESCRIPTION

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

    Image from Drug Label Content

    C25H27CIN2.2HCl.H2O  481.89

    The chemical name is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.

    Each tablet, for oral administration, contains 12.5 mg or 25 mg of Meclizine HCl. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, D&C yellow # 10 lake (25 mg only), FD&C blue # 1 lake (12.5 mg only), lactose monohydrate, microcrystalline cellulose, povidone (12.5 mg only), sodium starch glycolate, and stearic acid.

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  • ACTIONS

    Meclizine HCl 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. It has a slower onset and longer duration of action (24 hours) than most other antihistamines used for motion sickness.

    Antihistamines have been observed to have both stimulant and depressant effects on the CNS, but no clear explanation exists in regard to their diverse central actions. The site and mode of their central action is unknown.

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  • INDICATIONS:

    Prophylactic treatment and management of nausea and vomiting, and dizziness associated with motion sickness.

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  • CONTRAINDICATIONS

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

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  • WARNINGS

    Some drowsiness may, on occasion, occur with the 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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  • USAGE IN PEDIATRIC PATIENTS

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

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  • 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 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.

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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 of meclizine, should be taken 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 HCl Tablets USP are supplied as follows:

    12.5 mg: Blue/white, oval, bi-layer tablet debossed WATSON and 802 on one side and a partial bisect on the other side, in bottles of 100.

    25 mg: Yellow/white, oval, bi-layer tablet debossed WATSON and 803 on one side and a partial bisect on the other side, in bottles of 100 and 1000.

    Store at controlled room temperature 15°-30°C (59°- 86°F). Dispense in a well-closed container as defined in USP/NF.

    Manufactured For:
    Watson Laboratories, Inc.
    Corona, CA 92880 USA

    Manufactured by:
    Patheon Pharmaceuticals Inc.
    Cincinnati, OH 45215 USA

    Rev. 10/03
    70010599

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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0591-0803
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Meclizine Hydrochloride (Meclizine) 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    collidiol silicon dioxide  
    corn starch  
    D & C Yellow #10 lake  
    lactose monohydrate  
    microcrystalline cellulose  
    sodium starch glycolate  
    stearic acid  
    Product Characteristics
    Color WHITE (white) , YELLOW (yellow) Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code WATSON;803
    Contains     
    Coating false Symbol false
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0591-0803-01 100 in 1 BOTTLE
    2 NDC:0591-0803-10 1000 in 1 BOTTLE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0591-0802
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Meclizine Hydrochloride (Meclizine) 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    collidiol silicon dioxide  
    corn starch  
    FD & C Blue #1 lake  
    lactose monohydrate  
    microcrystalline cellulose  
    povidone  
    sodium starch glycolate  
    stearic acid  
    Product Characteristics
    Color BLUE (Blue) , WHITE (white) Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code WATSON;802
    Contains     
    Coating false Symbol false
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0591-0802-01 100 in 1 BOTTLE
    Labeler - Watson Laboratories, Inc.
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