JET-AVERT MOTION SICKNESS AID (MECLIZINE HYDROCHLORIDE) TABLET [BELL PHARMACEUTICALS, INC.]

JET-AVERT MOTION SICKNESS AID (MECLIZINE HYDROCHLORIDE) TABLET [BELL PHARMACEUTICALS, INC.]
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NDC 15579-837-23
Set ID 1fe1f806-cbf3-4308-8d70-201756e96cd1
Category HUMAN OTC DRUG LABEL
Packager Bell Pharmaceuticals, Inc.
Generic Name
Product Class Antiemetic
Product Number
Application Number PART336
  • Drug Facts
  • Active ingredient (in each tablet)

    Meclizine HCL 25mg

    Purpose

    Antiemetic

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  • Uses

    • prevent and treats nausea, vomiting, or dizziness associated with motion sickness
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  • 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.

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  • 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

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  • 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
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  • Inactive ingredients

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

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  • Questions or comments?

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

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    JET-AVERT MOTION SICKNESS AID 
    meclizine hydrochloride tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:15579-837
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LACTOSE (UNII: J2B2A4N98G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color red Score no score
    Shape ROUND Size 4mm
    Flavor Imprint Code 25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:15579-837-23 3 in 1 BOX 10/07/2017
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part336 10/07/2017
    Labeler - Bell Pharmaceuticals, Inc. (140653770)
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