Label: MECLIZINE 25- meclizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 9, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients (in each immediate-release tablet)

    Meclizine 25 mg

  • Purpose

    Antiemetic

  • Indications and Usage

    • For prevention and treatment of these symptoms associated with motion sickness:
      • nausea
      • vomiting
      • dizziness
  • Warnings

    • Do not use for children under 12 years of age unless directed by a doctor.

    Ask a doctor before use if you have

    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    • ask health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek medical help or contact a Poison Control Center immediately. 1-800-222-1222

  • Directions

    Do not exceed recommended dosage.

    To prevent motion sickness; take the first dose one hour before starting activity.

    Adults and children 12 years of age and over:1 to 2 tablets once daily, or as directed by a doctor.
  • Inactive ingredients

    Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

  • Questions and comments?

    Call 1-205-313-8298

  • SPL UNCLASSIFIED SECTION

    Manufactured for
    The Generic Pharmaceutical Company, Inc.
    Leeds, AL 35094

  • PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

    NDC 57963-101-01
    100 Tablets

    Meclizine 25
    Antiemetic

    Each immediate-release tablet contains:
    Meclizine HCl
    25 mg

    Store at 59°-86°F (15°-30°C)
    [see USP Controlled Room Temperature].
    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    Manufactured for
    The Generic Pharmaceutical Company, Inc.
    Leeds, AL 35094

    PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    MECLIZINE 25 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57963-101
    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
    Magnesium Stearate (UNII: 70097M6I30)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code MC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57963-101-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33612/01/2016
    Labeler - The Generic Pharmaceutical Company (078787060)
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