MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]

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MECLIZINE HCL TABLET [AIDAREX PHARMACEUTICALS LLC]
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NDC 33261-413-30, 33261-413-60
Set ID cf1332f0-8662-45ed-a76f-3e620f60f05b
Category HUMAN OTC DRUG LABEL
Packager Aidarex Pharmaceuticals LLC
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active Ingredient

    (in each tablet)

    Meclizine HCl 25 mg 

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting, or dizziness due to motion sickness

  • WARNINGS

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland

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

    When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • alcohol, sedatives & tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

      If pregnant or breast-feeding, ask a health professional before use.

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

  • Directions

    • take dose one hour before travel starts
    • tablets can be chewed or swallowed whole with water
    • adults & children 12 years and over: 1-2 tablets once daily

      children under 12 years: ask a doctor

  • Other Information

    • phenylketonurics: each tablet contains: phenylalanine 0.28mg
    • store at room temperature 15°-30°C (59°-86°F)
  • Inactive Ingredients

    aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

  • Questions or Comments

    Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

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

    Rugby® Duluth, Georgia 30097

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Meclizine HCl

    COMPARE TO ACTIVE INGREDIENT IN BONINE

    Meclizine HCl 25 mg (ANTIEMETIC)

    NDC 33261-0413-30

    30 CHEWABLE TABLETS

    Contains Aspartame

    Rugby

    Duluth, Georgia 30097

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

    IMAGE LABEL
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-413(NDC:0536-3990)
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ASPARTAME (UNII: Z0H242BBR1)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    Product Characteristics
    ColorREDScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33261-413-3030 in 1 BOTTLE, PLASTIC
    2NDC:33261-413-6060 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33607/22/2008
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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