Label: STAY AWAKE- caffeine tablet 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Caffeine 200 mg

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  • Purpose

    Alertness aid

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  • Uses

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

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  • Directions

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

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

    cellulose*, croscarmellose sodium*, D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate*, starch*

    *contains one or more of these ingredients

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  • Questions or comments?

    Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    Stay Awake

    Caffeine, 200 mg

    Maximum Strength Alertness Aid

    Safe & Effective

    Compare to the active ingredient in Vivarin®**

    DISTRIBUTED BY:  fred's, Inc.

    4300 NEW GETWELL RD, MEMPHIS, TN  38118

    www.fredsinc.com

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    TAMPER EVIDENT USE ONLY IF BLISTERS ARE INTACT

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  • Package Label

    Caffeine, 200 mg

    fred's Stay Awake Tablets

     

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  • INGREDIENTS AND APPEARANCE
    STAY AWAKE 
    caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55315-250
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAFFEINE (CAFFEINE) CAFFEINE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C YELLOW NO. 6  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SILICON DIOXIDE  
    POWDERED CELLULOSE  
    CROSCARMELLOSE SODIUM  
    SODIUM STARCH GLYCOLATE TYPE A CORN  
    STARCH, CORN  
    ALUMINUM OXIDE  
    Product Characteristics
    Color YELLOW Score no score
    Shape ROUND Size 11mm
    Flavor Imprint Code 212;212
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55315-250-16 2 in 1 CARTON
    1 8 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part340 03/01/2013
    Labeler - Freds Inc (005866116)
    Registrant - P and L Development of New York Corporation (800014821)
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