Label: MECLIZINE HCL- meclizine hydrochloride tablet

  • NDC Code(s): 16571-751-01, 16571-752-01
  • Packager: Rising Pharma Holdings, Inc.
  • 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 October 7, 2022

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  • Drug Facts Active ingredient (in each tablet)

    12.5 mg Tablet: Meclizine HCl    12.5 mg

    25 mg Tablet: Meclizine HCl     25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • Uses

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

  • Directions

    • dosage should be taken one hour before travel starts

    for 25 mg: adults and children 12 years and over, take 1 or 2 tablets once daily or directed by a doctor

    for 12.5 mg: adults and children 12 years and over, take 2 or 4 tablets once daily or directed by a doctor

  • Inactive Ingredients 

    magnesium sterate, microcrystalline cellulose, silicon dioxide, lactose monohydrate

  • Other Information

    Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

  • Questions or Comments?

    Call 1-844-474-7464

  • Warnings

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

    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

    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.

    In case of overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

    Manufactured by:

    Aurex laboratories LLC
    East Windsor, NJ 08520

    Distributed by:

    Rising Pharma Holdings, Inc.
    East Brunswick, NJ 08816

    Revised:08/2021

  • PRINCIPAL DISPLAY PANEL

    Meclizine HCl Tablets

    25 mg

    100

    meclizine-25mg-front

    meclizine-25mg-back

  • PRINCIPAL DISPLAY PANEL

    Meclizine HCl Tablets

    12.5 mg

    100

    meclizine-12.5mg

    meclizine-12.5mg-back

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-751
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (White to off white) Score2 pieces
    ShapeROUNDSize8mm
    FlavorImprint Code A;C4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-751-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/17/2021
    MECLIZINE HCL 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-752
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code AM7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-752-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33608/17/2021
    Labeler - Rising Pharma Holdings, Inc. (835513529)
    Registrant - Aurex Laboratories Limited Liability Company (067585317)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurex Laboratories Limited Liability Company067585317manufacture(16571-751, 16571-752) , pack(16571-751, 16571-752) , analysis(16571-751, 16571-752) , label(16571-751, 16571-752)
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