MECLIZINE 25 (MECLIZINE HYDROCHLORIDE) TABLET [THE GENERIC PHARMACEUTICAL COMPANY]

  • Home
  • MECLIZINE 25 (MECLIZINE HYDROCHLORIDE) TABLET [THE GENERIC PHARMACEUTICAL COMPANY]

MECLIZINE 25 (MECLIZINE HYDROCHLORIDE) TABLET [THE GENERIC PHARMACEUTICAL COMPANY]
PDF | XML
NDC 57963-101-01
Set ID b13cb390-20ed-43ce-aa74-5a754539f6e2
Category HUMAN OTC DRUG LABEL
Packager The Generic Pharmaceutical Company
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs