Label: STAY AWAKE- caffeine tablet

  • Category: HUMAN OTC DRUG LABEL

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 March 28, 2019

If you are a healthcare professional or from the pharmaceutical industry 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 heartbeat.

    Do not use

    • in children under 12 years
    • 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

  • Other information

    • 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, dextrose, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica gel

  • Questions or comments?

    (800) 616-2471

  • Principal Display Panel

    MAJOR®

    NDC 0904-7955-44

    STAY AWAKE
    Maximum Strength • Alertness Aid

    • For Fast Pick-Up - Safe As Coffee
    • Contains 200 mg Caffeine
      Equal to About A Cup Of Coffee

    *Compare to the
    active ingredient in
    Vivarin®

    16 Tablets

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

    *This product is not manufactured or distributed
    by Meda Consumer Healthcare, owner of the
    registered trademark Vivarin®.
    50844        REV0412E22621
    Distributed by MAJOR® PHARMACEUTICALS
    31778 Enterprise Drive, Livonia, MI 48150 USA
    M-17    Rev. 01/13         Re-order No. 700553

    Major 44-226

    Major 44-226

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7955
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7955-442 in 1 CARTON11/21/199611/15/2021
    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 FINALpart34011/21/199611/15/2021
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(0904-7955)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(0904-7955)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(0904-7955)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(0904-7955)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(0904-7955)