MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]

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MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]
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NDC 0536-3985-01, 0536-3985-10
Set ID d226fd69-fb4a-49e0-9933-85284cb01cb6
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active Ingredient

    (in each caplet)

    Meclizine HCl 12.5 mg USP

  • 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 a 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

    • adults and children 12 years and over: 2-4 caplets once daily
    • children under 12 years: ask a doctor
  • Other Information

    • each caplet contains: calcium 51 mg
    • store at room temperature 15°-30°C (59°-86°F)
  • Inactive Ingredients

    croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

  • Questions or Comments

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

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

    Rugby® Duluth, Georgia 30097

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    C:\Users\advance\Desktop\word docs - rugby\Meclizine 12.5 mg 100-1000 ct\Figure-4.png

    NDC 0536-3985-10

    Rugby

    Meclizine HCl 12.5 mg Caplets USP
    Antiemetic

    1000 caplets

    C:\Users\advance\Desktop\word docs - rugby\Meclizine 12.5 mg 100-1000 ct\Figure-2.png

    C:\Users\advance\Desktop\word docs - rugby\Meclizine 12.5 mg 100-1000 ct\Figure-3.png

    NDC 0536-3985-01

    Rugby

    Meclizine HCl 12.5 mg Caplets USP
    Antiemetic

    100 caplets

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3985
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeCAPSULESize13mm
    FlavorImprint Code AP;117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-3985-101000 in 1 BOTTLE
    2NDC:0536-3985-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/14/2006
    Labeler - Rugby Laboratories Inc. (191427277)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3985)
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