Label: JET-AVERT MOTION SICKNESS AID- meclizine hydrochloride tablet

  • NDC Code(s): 15579-837-23
  • Packager: Bell Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 October 9, 2017

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  • Drug Facts

  • Active ingredient (in each tablet)

    Meclizine HCL 25mg

    Purpose

    Antiemetic

  • Uses

    • prevent and treats nausea, vomiting, or dizziness associated with motion sickness
  • 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
    • glaucome 
    • difficulty in urination due to enlargement prostate glad

    Ask a doctor or pharmacist before useif you are taking

    • Sedatives • tranquilizers

    When using this product

    • drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • avoid alcoholic drinks • be careful when driving or operating machinery

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take first dose one hour before starting activity
     adults and children 12 years and over take 1 to 2 tablets once daily, or as directed by a doctor
     children under 12 years do not ues unless directed by doctor

  • Other information

    • store at room temperature between 59°-86°F (15°-30°C)
    • protect from excessive moisture 
    • don not use if tamper-evident seal is broken or missing
  • Inactive ingredients

    calcium stearate, FD&C red#40 aluminum lake, lactose, microcrystalline cellulose, silicon dioxide, sodium starch glycolate

  • Questions or comments?

    1-800-328-5890 Weekdays 8:30-5:00 CST

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    JET-AVERT MOTION SICKNESS AID 
    meclizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15579-837
    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
    CALCIUM STEARATE (UNII: 776XM7047L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE (UNII: J2B2A4N98G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code 25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15579-837-233 in 1 BOX10/07/2017
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33610/07/2017
    Labeler - Bell Pharmaceuticals, Inc. (140653770)