Label: MECLIZINE HCL- meclizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

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  • Active Ingredients (in each tablet)

    Meclizine HCl, USP 12.5 mg

  • Purpose

    Antiemetic

  • Uses:

    prevents and treats nausea, vomiting, or dizziness due to motion sickness.

  • Warnings:

    Do not take this product, unless directed by a doctor, if you have

    • Glaucoma
    • A breathing problem such as emphysema or chronic bronchitis
    • Trouble urinating due to an enlarged prostate gland.
  • Do not use in children under 12 years of age unless directed by a doctor.

  • ASK DOCTOR/PHARMACIST

    Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor

  • When using product

    • do not exceed recommended dosage
    • may cause drowsiness
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • use caution 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.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • Directions

    • dosage should be taken one hour before travel starts
     adults and children 12 years and over   take 2 or 4 tablets once daily or as directed by a doctor

  • Other Information

    • store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • Inactive ingredients

    colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

  • QUESTIONS

    Call 1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

    Distributed by:
    Drug Ocean LLC,
    1 Bridge Plaza, North Central Road,

    6th Floor, Suite 675,

    Fort Lee, NJ 07024

    Manufactured by:
    Unique Pharmaceutical Laboratories
    (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
    Mumbai 400 030, India

    ORG 12/23

  • PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

    NDC 70985-009-01

    Meclizine HCl

    12.5 mg

    100 Tablets

    Distributed by:

    Drug Ocean LLC,

    1 Bridge Plaza, North Central Road,

    6th Floor, Suite 675
    Fort Lee, NJ 07024

    Manufactured by:
    Unique Pharmaceutical Laboratories
    (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
    Mumbai 400 030, India

    ORG 12/23

    12.5

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-009
    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)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (White to Off White) Scoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code AB;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70985-009-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00906/25/2021
    Labeler - Drug Ocean LLC (080381835)
    Registrant - Drug Ocean LLC (080381835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(70985-009)
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