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
  • 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 July 28, 2022

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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 finalM00907/29/2022
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    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 finalM00907/29/2022
    Labeler - APNAR PHARMA LP (079568229)
    Establishment
    NameAddressID/FEIBusiness Operations
    APNAR PHARMA LLP118530917manufacture(24689-138, 24689-139) , analysis(24689-138, 24689-139) , pack(24689-138, 24689-139)
    Establishment
    NameAddressID/FEIBusiness Operations
    INVAHEALTH INC116840615label(24689-138, 24689-139) , pack(24689-138, 24689-139)
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