Label: MECLIZINE HYDROCHLORIDE tablet

  • NDC Code(s): 24689-138-01, 24689-139-01
  • Packager: APNAR PHARMA LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2025

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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)

    12.5mg tablet: Meclizine HCL.... 12.5 mg

    25mg tablet : Meclizine HCL .....25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

    Uses

    Prevents and treats nausea, vomiting or dizziness associated with motion sickness

  • DOSAGE & ADMINISTRATION

    Directions

    Meclizine HCL 12.5mg tablet :

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

    Meclizine HCL 25mg tablet:

    Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

  • STORAGE AND HANDLING

    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]

  • 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 urination due to an enlarged prostate gland

    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

    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)

  • QUESTIONS

    Questions or Comments?

    Call 1-855-642-2594

  • SPL UNCLASSIFIED SECTION

    Rev.: 05/2022

    Made in USA

    Manufactured by:

    APNAR PHARMA LLP

    East Windsor, NJ 08520

  • BOXED WARNING (What is this?)

    TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

  • PRINCIPAL DISPLAY PANEL

    NDC : 24689-138-01

    Meclizine Hydrochloride Tablets 12.5 mg

    Antiemetic

    100 Tablets

    Meclizine HCl 12.5 mg tablets -100s

    NDC : 24689-139-01

    Meclizine Hydrochloride Tablets 25 mg

    Antiemetic

    100 Tablets

    Meclizine HCl 25 mg _label-100s

  • INGREDIENTS AND APPEARANCE
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-138
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code A;C4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-138-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00907/29/2022
    MECLIZINE HYDROCHLORIDE 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-139
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code AM7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24689-139-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00907/29/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC116840615label(24689-138, 24689-139) , pack(24689-138, 24689-139)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917manufacture(24689-138, 24689-139) , analysis(24689-138, 24689-139) , pack(24689-138, 24689-139)
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