Label: AWAKE MAXIMUM STRENGTH- caffeine tablet, film coated

  • 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 May 31, 2016

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

  • Active ingredient (in each caplet)

    Caffeine 200 mg

    Close
  • Purpose

    Alertness aid

    Close
  • Uses

    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

    Close
  • 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.

    Close
  • 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
    Close
  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
    Close
  • Inactive ingredients

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

    Close
  • Questions or comments?

    1-800-426-9391

    Close
  • 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

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

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

    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


    Close
  • INGREDIENTS AND APPEARANCE
    AWAKE  MAXIMUM STRENGTH
    caffeine tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-3440
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE (UNII: IY9XDZ35W2)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL Size 15mm
    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 04/14/1998
    1 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part340 04/14/1998
    Labeler - Walgreen Company (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)
    Close