Label: MECLIZINE HCL- meclizine hydrochloride tablet

  • NDC Code(s): 68001-528-00
  • Packager: BluePoint Laboratories
  • 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 March 9, 2022

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

  • 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.

    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

  • PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

    NDC 68001-528-00

    Meclizine Hydrochloride Tablets, USP

    12.5 mg

    100 Tablets

    label

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-528
    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:68001-528-00100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33603/14/2022
    Labeler - BluePoint Laboratories (985523874)
    Registrant - Unique Pharmaceutical Laboratories (917165052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unique Pharmaceutical Laboratories650434645manufacture(68001-528)