Label: STAY AWAKE- caffeine tablet, coated

  • NDC Code(s): 69168-076-40, 69168-076-84
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2019

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  • Active ingredient(s)

    Caffeine 200mg

  • Purpose

    Alertness aid

  • Use

    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, sleep-

    lessness, and ocassionally 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 overdose, contact a doctor or Poison Control Center right away (1-800-222-1222).

  • Directions

    Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours

    Children under 12 years of age: do not use

  • Other information

    ■ store at room temperature 20º-25ºC (68º-77º F).

    ■ avoid excessive heat (greater than 100°F) and humidity

    ■ do not use if blister package is torn or open or if imprinted seal under safety cap is broken or missing.

  • 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

  • Questions or comments?

    Call 1-888-852-0050 Monday thru Friday 9am - 5pm EST

  • Principal Display Panel

    Stay Awake

    Stay Awake

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE 
    caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-076
    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, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    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:69168-076-842 in 1 CARTON07/01/2014
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:69168-076-401 in 1 CARTON02/01/2020
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01107/01/2014
    Labeler - Allegiant Health (079501930)
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