Label: MECLIZINE HCL- meclizine hydrochloride tablet

  • NDC Code(s): 57237-333-01
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • Drug Facts Active ingredient (in each tablet)

    Meclizine HCl, USP 12.5 mg

  • Purpose

    Antiemetic

  • Uses

    prevents and treats nausea, vomiting or dizziness associated with motion sickness.

  • Warnings

    Do not use in children under 12 years of age unless directed by a doctor.

  • 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
  • WARNINGS

    Do not take this product if you are

    taking sedatives or tranquilizers, without first consulting your doctor.

  • When using this 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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    dosage should be taken one hour before travel starts

    adults and children 12 years and overtake 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 or comments?

    Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

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

    Mfg. Lic. No.: G/1430

    Distributed by:
    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    Issued: 02/2024

    138528

  • PRINCIPAL DISPLAY PANEL - 12.5 mg tablets container label

    NDC 57237-333-01

    Meclizine Hydrochloride Tablets, USP

    12.5 mg

    100 Tablets

    meclizine-12.5mg-100ct

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-333
    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:57237-333-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM009.5007/22/2024
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(57237-333)
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