Label: MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

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

Drug Label Information

Updated March 16, 2015

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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.

  • 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

  • DESCRIPTION

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

    Structure

    C 25H 27ClN 2. 2HCl . H 2O 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%).

  • Principal Display Panel

    Meclizine Hydrochloride Tablets, USP 25mg

    30 Tablets

    NDC 10544-081-30

    25mg 30ct

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrocloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10544-081(NDC:59746-121)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColoryellowScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code TL121
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10544-081-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04065908/01/2012
    Labeler - Blenheim Pharmacal, Inc. (171434587)
    Registrant - Blenheim Pharmacal, Inc. (171434587)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blenheim Pharmacal, Inc.171434587repack(10544-081)