LESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]

LESS DROWSY FORMULA MOTION SICKNESS RELIEF (MECLIZINE HCL) TABLET [SALADO SALES, INC.]
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NDC 57243-403-02
Set ID 273235b0-dacc-4a95-91be-91e13a2c6d10
Category HUMAN OTC DRUG LABEL
Packager Salado Sales, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Active ingredient (in each tablet)

    Meclizine HCl 25 mg

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  • Purpose

    Antiemetic

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  • Uses

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

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  • 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

    • 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.

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  • 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
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • protect from heat and humidity
    • use by expiration date on package 
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  • Inactive ingredients

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

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  • Questions of comments?

    1-800-426-9391

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  • Principal Display Panel

    CVP®
    Health

    COMPARE TO
    DRAMAMINE®
    ALL DAY LESS DROWSY
    ACTIVE INGREDIENT*

    LESS DROWSY FORMULA
    MOTION SICKNESS
    RELIEF
    MECLIZINE HCl TABLETS 25 mg/ANTIEMETIC

    HELPS PREVENT NAUSEA & DIZZINESS
    DUE TO MOTION SICKNESS FOR
    UP TO 24 HOURS

    12 TABLETS

    ACTUAL SIZE

    TAMPER EVIDENT: Use Only if This Blister is Intact.

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

    50844        REV0219C40302

    Distributed by Consumer Value Products, Inc.
     P.O. Box 6115, Temple, Texas 76502   
    CVPproducts.com

    CVP 44-403

    CVP 44-403

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  • INGREDIENTS AND APPEARANCE
    LESS DROWSY FORMULA MOTION SICKNESS RELIEF 
    meclizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-403
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code 44;403
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57243-403-02 1 in 1 PACKAGE 06/24/2002
    1 12 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 06/24/2002
    Labeler - Salado Sales, Inc. (009830555)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(57243-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(57243-403)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(57243-403)
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