JET ALERT REGULAR STRENGTH (CAFFEINE) TABLET, COATED [BELL PHARMACEUTICALS, INC]

JET ALERT REGULAR STRENGTH (CAFFEINE) TABLET, COATED [BELL PHARMACEUTICALS, INC]
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NDC 15579-201-09, 15579-201-20
Set ID cd7366f9-6ee9-4f1d-bfd2-3ce067f59b2d
Category HUMAN OTC DRUG LABEL
Packager Bell Pharmaceuticals, Inc
Generic Name
Product Class
Product Number
Application Number PART340
  • Active ingredient (in each tablet)

    Caffeine 100 mg

  • Purpose

    Alertness Aid

  • Uses

    helps to restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

  • Warnings

    For occasional use only

    Do not use

    • in children under 12 years of age • as a substitute for sleep

    When using this product

    Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

    Stop use and ask a doctor if

    fatigue or drowsiness • persists • continues to recur

    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.

  • Directions

    • adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

  • Other information

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

  • Inactive ingredients

    calcium stearate, lactose, microcrystalline cellulose, silicon dioxide.

  • Questions?

    1-800-328-5890

    Weekdays 8:30-5:00 CST

  • Package Labeling:

    labeltablet

  • INGREDIENTS AND APPEARANCE
    JET ALERT REGULAR STRENGTH 
    caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15579-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code 100
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15579-201-201 in 1 CARTON07/27/2016
    1120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:15579-201-091 in 1 CARTON07/27/2016
    230 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34007/27/2016
    Labeler - Bell Pharmaceuticals, Inc (140653770)

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