Label: MECLIZINE HCL 12.5 MG- meclizine hcl 12.5 mg 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 May 2, 2017

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

  • Drug Facts
  • Active indredient (in each caplet)

    Meclizine HCL 12.5 mg

    Close
  • Purpose

    Antiemetic

    Close
  • Uses

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

    Close
  • 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
    Close
  • ASK DOCTOR/PHARMACIST

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

    Close
  • 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
    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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.

    Close
  • Directions

    adults & children 12 years and over: 2-4 caplets once daily
    children under 12 years: ask a doctor
    Close
  • 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.
    Close
  • Inactive ingredients

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

    Close
  • Questions or comments?

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

    Close
  • SPL UNCLASSIFIED SECTION

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

    Close
  • SPL UNCLASSIFIED SECTION

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

    Repackaged By: Preferred Pharmaceuticals Inc.

    www.reliable1labs.com

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 68788-6956

    Meclizine HCL 12.5 mg

    ANTIEMETIC

    Meclizine HCL 12.5mg Caplets
    Close
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 12.5 MG 
    meclizine hcl 12.5 mg tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6956(NDC:69618-027)
    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
    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
    Color white Score 2 pieces
    Shape OVAL Size 13mm
    Flavor Imprint Code AP;117
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-6956-1 10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/02/2017
    2 NDC:68788-6956-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/02/2017
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 05/02/2017
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6956)
    Close