Label: DRAMAMINE LESS DROWSY- meclizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 29, 2011

If you are a consumer or patient please visit this version.

  • 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

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

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  • Questions or comments?

    call 1-800-382-7219

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  • PRINCIPAL DISPLAY PANEL

    Meclizine hydrochloride tablets/Antiemetic
    Dramamine®
    LESS DROWSY FORMULA
    Provides Up To 24 Hours of Motion Sickness Protection
    Protection With Less Drowsiness!
    8 TABLETS (25 mg EACH)

    PRINCIPAL DISPLAY PANEL
Meclizine hydrochloride tablets/Antiemetic
Dramamine®
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)  
    COLLOIDAL 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
    1 8 in 1 BOTTLE
    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)
    Establishment
    Name Address ID/FEI Business Operations
    Contract Pharmacal Corporation 968334974 MANUFACTURE
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