Label: DRAMAMINE - N- meclizine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Meclizine HCl 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 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

  • Other information

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

  • Inactive ingredients

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

  • Questions?

    1-800-382-7219 Dramamine.com

  • PRINCIPAL DISPLAY PANEL

    Dramamine®-N

    Meclizine Hydrochloride Tablets/Antiemetic

    10 Tablets

    PRINCIPAL DISPLAY PANEL

Dramamine®-N
Meclizine Hydrochloride Tablets/Antiemetic

10 Tablets

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE - N 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-905
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-905-102 in 1 BOX01/15/2018
    15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00901/15/2018
    Labeler - Medtech Products Inc. (122715688)