LESS DROWSY MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [WAL-MART STORES INC]

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LESS DROWSY MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [WAL-MART STORES INC]
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NDC 49035-403-19, 49035-403-40
Set ID 277a6266-e641-4621-bbb9-64195d51b66a
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores 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

    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • 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

    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • 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.

    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?

     1-888-287-1915

  • Principal Display Panel

    NDC 49035-403-19

    equate™

    Compare to Dramamine® All Day Less Drowsy active ingredient*

    LESS DROWSY FORMULA
    Motion Sickness
    Relief

    Meclizine HCl, 25 mg

    Antiemetic
    • Helps prevent nausea
      and dizziness due to
      motion sickness

    Actual Size

     25
     mg         8 TABLETS
    EACH

    Distributed by: Walmart Inc., Bentonville, AR 72716
    PRODUCT OF INDIA
     *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® All Day Less Drowsy.

    50844     REV0219E40319

    Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

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

    Equate 44-403

    Equate 44-403

  • INGREDIENTS AND APPEARANCE
    LESS DROWSY MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-403
    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 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code 44;403
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-403-191 in 1 CARTON06/24/2002
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-403-408 in 1 BLISTER PACK; Type 0: Not a Combination Product06/24/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33606/24/2002
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(49035-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(49035-403)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(49035-403)
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