Label: DRAMAMINE- meclizine hydrochloride tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 give to

    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

    ■to prevent motion sickness take first dose ½ hour to 1 hour before activity that may result in nausea

    ■to treat motion sickness, take at first signs of symptoms

    ■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

    croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor

  • Questions?

    1-800-382-7219

  • PRINCIPAL DISPLAY PANEL

    All Day Less Drowsy Chewable Formula

    Dramamine®

    Meclizine HCl 25 mg /Motion Sickness Relief

    12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)

    PRINCIPAL DISPLAY PANEL All Day Less Drowsy Chewable Formula Dramamine® Meclizine HCl 25 mg /Motion Sickness Relief 12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)

  • INGREDIENTS AND APPEARANCE
    DRAMAMINE 
    meclizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-906
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize9mm
    FlavorRASPBERRY (Raspberry cream) Imprint Code 258
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-906-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product02/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00902/15/2019
    Labeler - Medtech Products Inc. (122715688)
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