Label: ALLERTNESS AID- caffeine tablet

  • 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 October 15, 2012

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  • ACTIVE INGREDIENT

    Active Ingredients Caffeine 200mg

  • PURPOSE

    Alertness Aid

  • DOSAGE & ADMINISTRATION

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

    Uses: helps restore mental alertness or wakefulness when
    experiencing fatigue or drowsiness

  • WARNINGS

    Warnings: For
    occasional use only. Do not use • in children under 12 years
    of age • as a substitute for sleep 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 heart beat.
    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.

  • INACTIVE INGREDIENT

    Inactive
    Ingredients: carnauba wax, colloidal silicon
    dioxide, dextrates, hypromellose, magnesium stearate,
    microcrystalline cellulose, polyethylene glycol, titanium
    dioxide

  • PRINCIPAL DISPLAY PANEL

    MM1

    Alertness Packet

  • INGREDIENTS AND APPEARANCE
    ALLERTNESS AID  
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-470
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    DEXTRATES (UNII: G263MI44RU)  
    Product Characteristics
    Colorwhite (snow white) Scoreno score
    ShapeROUND (TCL363) Size11mm
    FlavorImprint Code TCL363
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52904-470-022 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34010/15/2012
    Labeler - Select Corporation (053805599)
    Registrant - Select Corporation (053805599)
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