Label: MECLIZINE HCL 25 MG- meclizine hcl 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 November 30, 2018

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

  • Drug Facts
  • Active ingredient (in each tablet)

    Meclizine HCL 25 mg

    Close
  • Purpose

    Antiemetic

    Close
  • Uses

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

    you may get drowsy
    avoid alcoholic drinks
    alcohol, sedatives and tranquilizers 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 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
    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

    take dose one hour before travel starts
    tablets can be chewed or swallowed whole with water

    adults & children 12 years and over: 1-2 tablets once daily

    children unser 12 years: ask a doctor

    Close
  • Other information

    Phenylketonurics: each tablet contrains: phenylalanine 0.28 mg
    store at room temperature 15°-30°C (59°-86°F)
    This is a bulf package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
    Close
  • Inactive ingredients

    aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40 (Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

    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

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark BONINE®.

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

    Repackaged By: Preferred Pharmaceuticals Inc.

    www.reliable1labs.com

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 68788-6451-3

    Meclizine HCL 25 mg

    ANTIEMETIC

    THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

    *Compare to Active Ingredient in BONINE®

    Meclizine HCL 25mg Chewable Tablets
    Close
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-6451(NDC:69618-028)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    RASPBERRY (UNII: 4N14V5R27W)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SUCROSE (UNII: C151H8M554)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Color pink (Light Raspberry color) Score 2 pieces
    Shape ROUND Size 8mm
    Flavor RASPBERRY Imprint Code AP;115
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68788-6451-3 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/05/2016
    2 NDC:68788-6451-5 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/22/2017
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 08/05/2016
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    Name Address ID/FEI Business Operations
    Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-6451)
    Close