Label: STAY AWAKE MAXIMUM STRENGTH- 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 November 28, 2012

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  • Active ingredient (in each tablet)

    Caffeine 200 mg

  • Purpose

    Alertness aid

  • Use

    • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
  • Warnings

    • the recommended dose of this product contains about as much caffeine as one 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. 
    • For occasional use only. Not intended for use as a substitute for sleep
    • do not give to children under 12 years of age

    Stop use and ask a doctor if

    fatigue or drowsiness persists or continues to recur

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

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

  • Directions

    • adults and children 12 years of age and over: take 1 tablet (200 mg) not more often than every 3 to 4 hours
  • Other information

    • each tablet contains: calcium 60 mg
    • store at controlled room temperature 15-30°C (59-86°F)
    • avoid excessive heat and humidity
  • Inactive ingredients

    D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose and silica. May also contain: cellulose, croscarmellose sodium, sodium starch glycolate and starch

  • Principal Display Panel

    Maximum strength Alertness Aid

    Each tablet contains 200 mg caffeine equal to about one cup of coffee

    Stay Awake

    compare to active ingredient in Vivarin® *

    * This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Vivarin®

    TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT

    BEST CHOICE VALU MERCHANDISERS

    Caffeine 200 mg

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE  MAXIMUM STRENGTH
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-252
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 212;212
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-252-162 in 1 CARTON
    18 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34009/21/2010
    Labeler - Valu Merchandisers Company (Best Choice) (868703513)
    Registrant - P and L Development of New York Corporation (800014821)
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