Label: DRAMAMINE- meclizine hydrochloride tablet, chewable

  • 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 July 5, 2019

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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 FINALpart33602/15/2019
    Labeler - Medtech Products Inc. (122715688)
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