Label: MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet

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

Drug Label Information

Updated January 12, 2014

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  • DESCRIPTION

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

    Structure of Meclizine HCl

                              C25H27ClN2. 2HCl. H2O                                                                                        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%).

  • 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:


    25 mg (Yellow, oval-shaped, scored, debossed with TL121)

    Bottles of 8            NDC 33261--0718-08
    Bottles of 10          NDC 33261--0718-10
    Bottles of 20          NDC 33261--0718-20
    Bottles of 30          NDC 33261--0718-30
    Bottles of 60          NDC 33261--0718-60


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

    Manufactured By:

    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA.

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

    Revised 03/11

  • PRINCIPAL DISPLAY PANEL

    IMAGE LABEL

    NDC 33261-0718-30


    Meclizine Hydrochloride Tablets, USP

    25 mg

    Rx only

    30 Tablets

    Each tablet contains 25 mg of meclizine HCl.

    DOSAGE AND USE 
    See accompanying prescribing information

    MOTION SICKNESS:
    25 mg to 50 mg daily.

    Dispense in tight, light-resistant containers (USP).

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

    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

    Rev.# 03/11

    Lot No.:

    Exp Date:

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrocloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:33261-718(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:33261-718-088 in 1 BOTTLE, PLASTIC
    2NDC:33261-718-1010 in 1 BOTTLE, PLASTIC
    3NDC:33261-718-2020 in 1 BOTTLE, PLASTIC
    4NDC:33261-718-3030 in 1 BOTTLE, PLASTIC
    5NDC:33261-718-6060 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04065906/04/2010
    Labeler - Aidarex Pharmaceuticals LLC (801503249)