Label: MECLIZINE HCL 25 MG- meclizine hcl tablet

  • Category: HUMAN OTC DRUG LABEL

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 July 26, 2023

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  • Drug Facts

  • Active ingredient (in each tablet)

    Meclizine HCL 25 mg

  • Purpose

    Antiemetic

  • Uses

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

  • 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 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 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

    •
    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

  • 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.
  • Inactive ingredients

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

  • 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

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

    Repackaged By: Preferred Pharmaceuticals Inc.

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

    www.reliable1labs.com

  • PRINCIPAL DISPLAY PANEL

    NDC 68788-7982

    Meclizine HCL 25 mg

    ANTIEMETIC

    THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

    *Compare to Active Ingredient in BONINE®

    Meclizine HCL 25mg Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7982(NDC:69618-028)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorpink (Light Raspberry color) Score2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-7982-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/2021
    2NDC:68788-7982-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/28/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33607/28/2021
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022REPACK(68788-7982)
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