Label: AWAKE- caffeine tablet 

  • Label RSS
  • 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 05/14

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

  • Active ingredient (in each caplet)

    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

    For occasional use only

    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 heartbeat.

    Do not use

    • in children under 12 years of age
    • as a substitute for sleep

    Stop use and ask a doctor if

    fatigue or drowsiness persists or continues to recur.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

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  • Directions

    • adults and children 12 years of age and over: take 1/2 to 1 caplet not more often than every 3 to 4 hours
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    corn starch, dextrose, dicalcium phosphate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid

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  • Questions or comments?

     1-800-426-9391

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  • Principal Display Panel

    Well at
    Walgreens

    NDC 0363-3440-11

    Maximum Strength
    Awake
    Caffeine 200 mg /
    Alertness Aid
    • Fast acting • Easy to swallow

    60
    COATED CAPLETS

    Compare to Maximum Strength NoDoz® active ingredientǂǂ

    ǂǂThis product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Maximum Strength NoDoz®.
    50844    REV0813A34411

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    Walgreens
    100% SATISFACTION GUARANTEED
    walgreens.com    ©2012 Walgreen Co.

    Walgreens 44-344

    Walgreens 44-344


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  • INGREDIENTS AND APPEARANCE
    AWAKE 
    caffeine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-3440
    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
    DEXTROSE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    STARCH, CORN  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape CAPSULE Size 10mm
    Flavor Imprint Code 44;344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-3440-11 1 in 1 CARTON
    1 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part340 04/14/1998
    Labeler - WALGREEN CO. (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-3440)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-3440)
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