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

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  • Active Ingredients (in each caplet)

    Meclizine HCl 12.5 mg

  • Purpose

    Antiemetic

  • Uses:

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

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

  • ASK DOCTOR/PHARMACIST

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

  • 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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a Physician 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 & children 12 years and over: 2-4 caplets once daily

    • Children under 12 years: ask a doctor

  • HOW SUPPLIED

  • Other Information

    • each caplet contains: calcium 51 mg

    • Store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

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

  • 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

  • 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
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride tablets tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13811-646(NDC:57631-007)
    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
    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
    ColorWHITEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code ET5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13811-646-10100 in 1 BOTTLE
    2NDC:13811-646-011000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/23/2013
    Labeler - Trigen Laboratories, Inc. (830479668)
    Registrant - Trigen Laboratories, Inc.. (830479668)
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