MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]

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MECLIZINE HCL TABLET [BRYANT RANCH PREPACK]
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NDC 63629-4008-1, 63629-4008-2, 63629-4008-3, 63629-4008-4, 63629-4008-5, 63629-4008-6, 63629-4008-7, 63629-4008-8
Set ID 31791f62-2700-4ffb-bced-4a27159d0b8c
Category HUMAN OTC DRUG LABEL
Packager Bryant Ranch Prepack
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

  • PRINCIPAL DISPLAY PANEL

    Meclizine 25MG Chewable

    Label
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-4008(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:63629-4008-130 in 1 BOTTLE
    2NDC:63629-4008-220 in 1 BOTTLE
    3NDC:63629-4008-325 in 1 BOTTLE
    4NDC:63629-4008-440 in 1 BOTTLE
    5NDC:63629-4008-560 in 1 BOTTLE
    6NDC:63629-4008-690 in 1 BOTTLE
    7NDC:63629-4008-78 in 1 BOTTLE
    8NDC:63629-4008-814 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/22/2008
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-4008) , RELABEL(63629-4008)
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