DRAMAMINE - N (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]

DRAMAMINE - N (MECLIZINE HYDROCHLORIDE) TABLET [MEDTECH PRODUCTS INC.]
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NDC 63029-905-10
Set ID 7fec7791-c242-4e43-8184-32820e657afb
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 HCl 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 activity that may result in nausea

    ■ 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 room temperature 20°–25°C (68°-77°F) 

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  • Inactive ingredients

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

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  • Questions?

    1-800-382-7219 Dramamine.com

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  • PRINCIPAL DISPLAY PANEL

    Dramamine®-N

    Meclizine Hydrochloride Tablets/Antiemetic

    10 Tablets

    PRINCIPAL DISPLAY PANEL

Dramamine®-N
Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets

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  • INGREDIENTS AND APPEARANCE
    DRAMAMINE - N 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-905
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (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:63029-905-10 2 in 1 BOX 01/15/2018
    1 5 in 1 BLISTER PACK; 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 01/15/2018
    Labeler - Medtech Products Inc. (122715688)
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