DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]

DRAMAMINE LESS DROWSY (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]
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NDC 63029-903-01
Set ID fa6a0969-7427-4b87-bc04-a2792665c218
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    (in each tablet)

    Meclizine HCI 25 mg

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  • Purpose

    Antiemetic

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  • Use

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

    • nausea
    • vomiting
    • dizziness
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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

    • 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.

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  • 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
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  • Other information

    • store between 20 - 25ºC (68 - 77ºF)
    • do not use if blister is broken or torn
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  • Inactive ingredients

    corn starch, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose

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  • Questions?

    1-800-382-7219

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  • PRINCIPAL DISPLAY PANEL

    All Day LESS DROWSY
    Dramamine®
    Meclizine hydrochloride tablets/Antiemetic


    8 TABLETS (25 mg EACH)

    PRINCIPAL DISPLAY PANEL
All Day LESS DROWSY 
Dramamine®
Meclizine hydrochloride tablets/Antiemetic 

8 TABLETS (25 mg EACH)

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  • INGREDIENTS AND APPEARANCE
    DRAMAMINE LESS DROWSY 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-903
    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
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Color YELLOW Score 2 pieces
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-903-01 1 in 1 BLISTER PACK 09/01/2011
    1 8 in 1 BOTTLE; 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 09/01/2011
    Labeler - Medtech Products Inc. (122715688)
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