Label: MECLIZINE HCL- meclizine hydrochloride tablets tablet

  • 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 September 15, 2013

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

  • Active Ingredients (in each caplet)

    Meclizine HCl 12.5 mg

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  • Purpose

    Antiemetic

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  • Uses:

    prevents and treats nausea, vomiting, or dizziness due to motion sickness.• For other uses, consult your doctor.

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  • WARNING: 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.

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  • KEEP OUT OF REACH OF CHILDREN
  • ASK DOCTOR/PHARMACIST

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

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  • When using product

    • You may get drowsy • Avoid alcoholic drinks • Alcohol, sedatives and tranquilizers may increase drowsiness • Be careful when driving a motor vehicle or operating machinery

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a Physician before use.

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  • 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 & 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

    Microcrystalline cellulose, magnesium stearate, sodium starch glycolate, crospovidone, talc, and lactose.

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  • SPL UNCLASSIFIED SECTION

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

    TRIGEN
    LABORATORIES

    Manufactured for:
    TRIGEN Laboratories, Inc., Sayreville, NJ 08872
    www.trigenlab.com
    Rev. 08/13

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  • PRINCIPAL DISPLAY PANEL - 12.5 mg Caplet Label

    NDC 13811-646-10

    Meclizine HCl
    12.5 mg

    100 CAPLETS

    TRIGEN
    LABORATORIES

    Manufactured for:
    TRIGEN Laboratories, Inc., Sayreville, NJ 08872
    www.trigenlab.com
    Rev. 08/13

    PRINCIPAL DISPLAY PANEL - 12.5 mg - 100 caplets
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  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride tablets tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:13811-646(NDC:57631-007)
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TALC (UNII: 7SEV7J4R1U)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code ET5
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:13811-646-10 100 in 1 BOTTLE
    2 NDC:13811-646-01 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 09/23/2013
    Labeler - Trigen Laboratories, Inc. (830479668)
    Registrant - Trigen Laboratories, Inc.. (830479668)
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