MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [RPK PHARMACEUTICALS, INC.]

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  • MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [RPK PHARMACEUTICALS, INC.]

MECLIZINE HCL 25 MG (MECLIZINE HYDROCHLORIDE) TABLET, CHEWABLE [RPK PHARMACEUTICALS, INC.]
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NDC 53002-7650-1, 53002-7650-2, 53002-7650-3
Set ID 66431c8c-28e3-4b1e-82aa-5951428fd65f
Category HUMAN OTC DRUG LABEL
Packager RPK Pharmaceuticals, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each chewable tablet)

    Meclizine HCl, USP 25 mg

  • PURPOSE

    Purpose

    Antiemetic

  • INDICATIONS & USAGE

    Uses

    prevents and treats nausea, vomiting or dizziness due to motion sickness

  • WARNINGS

    Warnings

  • DO NOT USE

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

  • ASK DOCTOR

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • trouble urinating due to an enlarged prostate gland
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

  • WHEN USING

    When using this product

    • 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 the poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • dosage should be taken one hour before travel starts.
    • adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
    • children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor
  • STORAGE AND HANDLING

    Other information

    • phenylketonurics: contains phenylalanine 0.28 mg per tablet
    • store at room temperature in a dry place
  • INACTIVE INGREDIENT

    Inactive ingredients Aspartame, croscarmellose sodium, dextrose, FD&C red #40 lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

  • QUESTIONS

    Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

  • SPL UNCLASSIFIED SECTION

    Distributed by: Plus Pharma, Commack, NY 11725

    *Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

  • HOW SUPPLIED

    Product: 53002-7650

    NDC: 53002-7650-1 10 TABLET, CHEWABLE in a BOTTLE

    NDC: 53002-7650-2 20 TABLET, CHEWABLE in a BOTTLE

    NDC: 53002-7650-3 30 TABLET, CHEWABLE in a BOTTLE

  • Meclizine 25mg Chewtabs

    Label Image
  • INGREDIENTS AND APPEARANCE
    MECLIZINE HCL 25 MG 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53002-7650(NDC:51645-994)
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    SUCROSE (UNII: C151H8M554)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    Product Characteristics
    Colorpink (Uncoated) Score2 pieces
    ShapeROUND (Biconvex) Size8mm
    FlavorRASPBERRYImprint Code 21G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53002-7650-330 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    2NDC:53002-7650-110 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    3NDC:53002-7650-220 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33610/15/2015
    Labeler - RPK Pharmaceuticals, Inc. (147096275)
    Establishment
    NameAddressID/FEIBusiness Operations
    RPK Pharmaceuticals, Inc.147096275RELABEL(53002-7650) , REPACK(53002-7650)
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