MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]

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  • MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]

MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET, CHEWABLE [PURACAP PHARMACEUTICAL LLC]
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NDC 51013-322-54
Set ID 8d772ff0-1476-48ca-a7e4-9473ce3db83a
Category HUMAN OTC DRUG LABEL
Packager PuraCap Pharmaceutical LLC
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each tablet)

    Meclizine Hydrochloride 25 mg

  • Purpose

    Antiemetic

  • Uses

    for prevention and treatment of these symptoms associated with motion sickness:

    • nausea
    • vomiting
    • dizziness
  • Warnings

    Do not use

    for children under 12 years of age unless directed by a doctor

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding,

    ask a doctor before use.

    Keep out of reach of children.

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

  • Directions

    • take first dose one hour before starting activity
    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • Other information

    • Phenylketonurics: each tablet contains: phenylalanine 0.28 mg
    • store at room temperature 15º - 30ºC (59º - 86ºF)
  • Inactive ingredients

    Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

  • Questions or comments?

    Call toll free: 1-855-215-8180

  • PRINCIPAL DISPLAY PANEL

    Motion Sickness Relief

    30 Tablets   15 Pouches (2 Tablets per Pouch)

    NDC 51013-322-54

    CVSF36-00

    CVSB36-00

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-322
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    RASPBERRY (UNII: 4N14V5R27W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore2 pieces
    ShapeROUNDSize8mm
    FlavorRASPBERRYImprint Code AP;115
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51013-322-5415 in 1 CARTON11/28/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33611/28/2017
    Labeler - PuraCap Pharmaceutical LLC (962106329)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(51013-322)
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