Label: JET ALERT DOUBLE STRENGTH- caffine tablet, coated

  • NDC Code(s): 15579-200-16, 15579-200-31
  • Packager: Bell Pharmaceuticals, Inc
  • 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 November 16, 2018

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  • Active ingredient (per caplet)

    Caffeine 200 mg

  • Purpose

    Alertness Aid

  • Uses

    Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • Warnings

    Do not give to children under 12 years of age. The recommended dose of this product contains about as much caffeine as two cup of coffee. 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 heart beat. No stimulant should be substituted for normal sleep in activities requiring mental alertness.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • Caution:

    Do not take this product without consulting a physician if under medical care.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

  • Directions

    Adults and children 12 years of age and over: oral dosage is 1 caplet. After the initial dosage, 1 caplet every 3 hours should be sufficient.

  • Questions:

    Call 1-800-328-5890

    Weekdays 8AM-4:30PM CST

  • Inactive ingredients

    Calcium Stearate, D&C Yellow #10, Lactose, microcrystalline cellulose, Silicon Dioxide.

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA

    By Bell Pharmaceutucals, Inc.

    Belle Plaine, MN 56011

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN

  • JET-ALERT, Caffeine 200mg, 90 caplets (15579-200-16) JET-ALERT, Caffeine 200mg, 16 caplets (15579-200-31)

    carton

    label

  • INGREDIENTS AND APPEARANCE
    JET ALERT DOUBLE STRENGTH 
    caffine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15579-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM STEARATE (UNII: 776XM7047L)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeCAPSULESize16mm
    FlavorImprint Code 200
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15579-200-311 in 1 CARTON11/26/2014
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:15579-200-161 in 1 CARTON11/26/2014
    290 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34011/26/2014
    Labeler - Bell Pharmaceuticals, Inc (140653770)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals, Inc140653770manufacture(15579-200)
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