Label: MECLIZINE HCL- meclizine hydrochloride 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 June 28, 2021

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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,
    221 River Street, Suite 9051,
    Hoboken, NJ 07030

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

    ORG 05/21

  • PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

    NDC 70985-009-01

    Meclizine HCl
    12.5 mg

    100 Tablets

    Distributed by:
    Drug Ocean LLC,
    221 River Street, Suite 9051,
    Hoboken, NJ 07030

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

    ORG 05/21

    PRINCIPAL DISPLAY PANEL - 12.5 mg - 100 caplets

    PRINCIPAL DISPLAY PANEL - 12.5 mg - 100 caplets

  • 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 finalpart33606/25/2021
    Labeler - Drug Ocean LLC (080381835)
    Registrant - Drug Ocean LLC (080381835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(70985-009)
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