Label: MECLIZINE HCL - meclizine hcl tablet

  • NDC Code(s): 0536-3985-01, 0536-3985-10
  • Packager: Rugby Laboratories Inc.
  • 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 December 9, 2012

If you are a consumer or patient please visit this version.

  • Active Ingredient

    (in each caplet)

    Meclizine HCl 12.5 mg USP

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  • Purpose

    Antiemetic

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  • Uses

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

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  • 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.

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  • Directions

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

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

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

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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3985
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score 2 pieces
    Shape CAPSULE Size 13mm
    Flavor Imprint Code AP;117
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-3985-10 1000 in 1 BOTTLE
    2 NDC:0536-3985-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 07/14/2006
    Labeler - Rugby Laboratories Inc. (191427277)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3985)
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