Label: STAY AWAKE MAXIMUM STRENGTH- caffeine tablet

  • NDC Code(s): 64092-020-16
  • Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
  • 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 January 7, 2021

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

  • Active ingredient (in each tablet)

    Caffeine 200 mg

  • Purpose

    Alertness aid

  • Uses

    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
    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • 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?

    Call 1-800-426-9391

  • Principal Display Panel

    HEALTHCARE™

    NDC 64092-020-16

    Maximum Strength
    Stay Awake
    Caffeine 200 mg each
    Alertness Aid

    Equal to about a cup of coffee

    *Compare to the
    active ingredient
    in Vivarin®

    Actual Size

    16 TABLETS

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this
    product, regardless of reason, return your unused
    portion to Great Lakes Wholesale for a full refund

    Distributed by: Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave., S.E., Grand Rapids, MI 49512
    www.glwholesale.com     50844          REV1219F22621

    44-226

    44-226

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE  MAXIMUM STRENGTH
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-020
    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 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-020-162 in 1 CARTON11/21/1996
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34011/21/1996
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(64092-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(64092-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(64092-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(64092-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(64092-020)