MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]

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MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [L.N.K. INTERNATIONAL, INC.]
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NDC 50844-403-19
Set ID 8e1889de-fbef-44f1-bbfb-c68a78e6330c
Category HUMAN OTC DRUG LABEL
Packager L.N.K. International, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
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  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

  • Purpose

    Antiemetic

  • Uses

    for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

  • Warnings

    Do not use

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

    Ask a doctor before use if you have

    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis 

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • drowsiness may occur
    • use caution when driving a motor vehicle or operating machinery
    • avoid alcoholic beverages

    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 (1-800-222-1222) right away.

  • Directions

    • to prevent motion sickness, take the first dose 1/2 hour to 1 hour before starting activity
    • to treat motion sickness, take at first signs of symptoms
    • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    QUALITY
    +PLUS

    NDC 50844-403-19

    *Compare to active ingredient in
    Dramamine® All Day Less Drowsy

    Motion Sickness
    Relief
    LESS DROWSY FORMULA
    Meclizine HCl 25 mg  • Antiemetic

    HELPS PREVENT NAUSEA, VOMITING AND
    DIZZINESS DUE TO MOTION SICKNESS
    FOR UP TO 24 HOURS

    8 Tablets

    ACTUAL
    SIZE

    TAMPER EVIDENT: DO NOT USE IF
    PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark
    Dramamine® All Day Less Drowsy.      50844       REV0219C40319

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    Quality Plus 44-403

    Quality Plus 44-403

  • INGREDIENTS AND APPEARANCE
    MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-403
    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
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-403-191 in 1 CARTON06/24/2002
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33606/24/2002
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(50844-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(50844-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(50844-403)
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