Label: ALERT- caffeine tablet, film coated

  • 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 December 17, 2018

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Caffeine 200 mg

  • PURPOSE

    Purpose


    Alertness aid

  • INDICATIONS & USAGE

    Uses


    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • WARNINGS

    Warnings

    For occasional use only

  • DO NOT USE

    • Do not use

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

  • OTHER SAFETY INFORMATION

    Caffeine warning:

    The recommended dose of this product contains about as much

    caffeine

    as a 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 heartbeat.
  • STOP USE

    Stop use and ask a doctor if

    fatigue or drowsiness persists or continues to recur

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

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

  • STORAGE AND HANDLING

    Other information

    • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive heat (greater than 100°F) or humidity
    • use by expiration date on package
  • INACTIVE INGREDIENT

    Inactive ingredients

    carnauba wax, colloidal silicon dioxide, D-C yellow #10 aluminum lake, dextrates, FD-C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
  • PRINCIPAL DISPLAY PANEL

    IMAGE OF BOTTLE LABEL
  • INGREDIENTS AND APPEARANCE
    ALERT 
    caffeine tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-343
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code TCL;343
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49483-343-4440 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34011/30/2011
    Labeler - Time Cap Labs, Inc (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Labs, Inc037052099manufacture(49483-343)
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