Label: STAY AWAKE- caffeine tablet, coated

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 21, 2016

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  • Active ingredient(s)

    Caffeine 200mg

  • Purpose

    Alertness aid

  • Uses

    helps 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 because too much caffeine may cause nervousness, irritability, sleeplessness, and occasional 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 or continues to occur.

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • Adults and children 12 years of age and older: take 1 tablet not more often than every 3 to 4 hours
    • Children under 12 years of age: do not use
  • Other information

    • store at room temperature 68º-77ºF (20º-25ºC)
    • avoid excessive heat (greater than 100ºF)
    • do not use if carton is opened or blister unit is broken
  • Inactive ingredients

    croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • Principal Display Panel

    Stay Awake

    Stay Awake

     

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE 
    caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-076
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;076
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-076-842 in 1 CARTON07/01/2014
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01107/01/2014
    Labeler - Marc Glassman, Inc. (094487477)
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