Label: MECLIZINE HYDROCHLORIDE  - meclizine hydrochloride tablet 

  • Label RSS
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/11

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  • DESCRIPTION

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

    Structure of Meclizine HCl

                              C H ClN 2HCl H O                                                                                        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%). 25272..2...

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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 management of nausea and vomiting, and 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 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

    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.  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, Teratogenic Effects

    Pediatric Use

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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

    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. Motion Sickness

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  • HOW SUPPLIED

    NDC:50436-3986-1 in a BOTTLE of 30 TABLETS

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  • MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCHLORIDE) TABLET MECLIZINE HYDROCHLORIDE (MECLIZINE HYDROCLORIDE) TABLET
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE  
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50436-3986(NDC:59746-122)
    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
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    FD&C BLUE NO. 1  
    ALUMINUM OXIDE  
    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:50436-3986-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040659 06/04/2010
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-3986)
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