Label: MECLIZINE - meclizine hcl tablet

  • NDC Code(s): 10267-3206-1, 10267-3206-4
  • Packager: Contract Pharmacal Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 26, 2011

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Drug Facts

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  • Active ingredient

    (in each tablet)

    Meclizine HCl 25 mgi

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  • Purpose

    Antiemetic

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  • Uses

    for the prevention and treatment of the nausea, vomiting, dizziness associated with motion sickness

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  • Warnings

    Do not use

    • In children under 12 years of age unless directed by a doctor
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  • Ask a doctor before use if you have

    • breathing problems such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlarged prostate gland
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  • Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

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  • When using this product

    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
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  • If pregnant or breast-feeding,

    ask a health care professional before use.

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  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    • To prevent motion sickness, the first dose should be taken one hour before starting activity.
    • Adults and children 12 years of age and over: chew 1 to 2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor.

    DO NOT EXCEED RECOMMENDED DOSE

    Other information

    • Store at room temperature, USP
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  • Inactive ingredient

    Corn Starch, Croscarmellose Sodium, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.

    R02/11

    Manufactured by:
    Contract Pharmacal Corp.
    135 Adams Avenue
    Hauppauge, NY 11788 USA
    www.cpc.com

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    MECLIZINE 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10267-3206
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    RASPBERRY (UNII: 4N14V5R27W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    VANILLA (UNII: Q74T35078H)  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 9mm
    Flavor Imprint Code 258
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10267-3206-1 100 in 1 BOTTLE
    2 NDC:10267-3206-4 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part336 07/24/2001
    Labeler - Contract Pharmacal Corp (968334974)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corp 968334974 MANUFACTURE
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