MECLIZINE HCL 12.5 MG TABLET [PREFERRED PHARMACEUTICALS INC.]

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MECLIZINE HCL 12.5 MG TABLET [PREFERRED PHARMACEUTICALS INC.]
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NDC 68788-6956-1, 68788-6956-3
Set ID 61d5c154-1927-46b1-aba3-625831d17ac1
Category HUMAN OTC DRUG LABEL
Packager Preferred Pharmaceuticals Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Drug Facts

  • Active indredient (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
  • Warnings

    Ask a docotor 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 and tranquillizers 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.

  • ASK DOCTOR

    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 DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this prodcut

    •
    you may get drowsy
    •
    avoid alcoholic drinks
    •
    alcohol, sedatives and tranqulizers may increase drowsiness
    •
    be careful when driving a motor vehicle or operating machinery
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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
  • Other information

    •
    each caplet contains: calcium 51 mg
    •
    store at room temperature 15º-30ºC (59º-86ºF)
    •
    This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
  • Inactive ingredients

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

  • Questions or comments?

    call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580

    Repackaged By: Preferred Pharmaceuticals Inc.

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 68788-6956

    Meclizine HCL 12.5 mg

    ANTIEMETIC

    Meclizine HCL 12.5mg Caplets
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 12.5 MG 
    meclizine hcl 12.5 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6956(NDC:69618-027)
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code AP;117
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-6956-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/02/2017
    2NDC:68788-6956-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/02/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33605/02/2017
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-6956)
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