Label: 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 July 16, 2020

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

  • 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)