Label: DRAMAMINE LESS DROWSY- meclizine hydrochloride tablet

  • NDC Code(s): 63029-903-01, 63029-903-10
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    (in each tablet)

    Meclizine HCI 25 mg

  • Purpose

    Antiemetic

  • Use

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

    • nausea
    • vomiting
    • dizziness
  • 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.

  • 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
  • Other information

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

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

  • Questions or comments?

    call 1-800-382-7219

  • PRINCIPAL DISPLAY PANEL

    MECLIZINE HYDROCHLORIDE
    TABLETS/ANTIEMETIC
    Dramamine®
    motion sickness
    LESS DROWSY
    Dual Action:
    Prevents & Relieves Nausea,
    Dizziness and Vomiting
    8 TABLETS
    (25 mg EACH)

    MECLIZINE HYDROCHLORIDE TABLETS/ANTIEMETIC Dramamine® motion sickness LESS DROWSY Dual Action: Prevents & Relieves Nausea, Dizziness and Vomiting 8 TABLETS (25 mg EACH)

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE LESS DROWSY 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-903
    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
    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
    ColoryellowScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-903-011 in 1 BLISTER PACK09/01/2011
    18 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:63029-903-102 in 1 CARTON09/01/2011
    25 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00909/01/2011
    Labeler - Medtech Products Inc. (122715688)
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