Label: STAY AWAKE MAXIMUM STRENGTH- caffeine tablet

  • NDC Code(s): 0363-0226-08, 0363-0226-10, 0363-0226-12, 0363-0226-21
  • Packager: Walgreen Company
  • 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 June 3, 2022

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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

    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 heart beat.

    Do not use

    • for 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 right away.

  • Directions

    • adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours
    • children under 12 years: do not use
  • Other information

    • each tablet contains: calcium 35 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C yellow #10 aluminum lake, dextrates hydrated, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    Walgreens

    Compare to Vivarin® active ingredient††

    NDC 0363-0226-12

    Stay Awake

    CAFFEINE 200 mg / ALERTNESS AID

    MAXIMUM STRENGTH

    • Caffeine for mental alertness

    • Equal to about a cup of coffee

    100 TABLETS 

    ACTUAL SIZE

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

    ††This product is not manufactured or distributed by Meda AB, owner of the registered trademark Vivarin®.
    50844   REV1219A22612

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED 
    walgreens.com  ©2018 Walgreen Co.

    44-226

    44-226

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE  MAXIMUM STRENGTH
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0226
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0226-121 in 1 CARTON11/21/199612/21/2023
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0226-212 in 1 CARTON11/21/199607/08/2018
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0363-0226-105 in 1 CARTON11/21/199602/25/2023
    38 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0363-0226-083 in 1 CARTON11/21/199608/14/2021
    48 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34011/21/199612/21/2023
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(0363-0226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(0363-0226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0363-0226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0226)
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