Label: STAY AWAKE- caffeine tablet

  • 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 10, 2020

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 heartbeat.

    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?

    1-888-287-1915

  • Principal Display Panel

    equate™

    NDC 49035-226-31

    Compare
    to Vivarin®
    Active
    Ingredient*

    Stay Awake
    Caffeine 200 mg
    Alertness Aid

    • Equal To About A
    Cup of coffee

    200 mg EACH

    80 TABLETS

    Actual Size

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

    Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915.

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
    PRODUCT OF CHINA AND GERMANY

    *This product is not manufactured or distributed by Meda AB, owner
    of the registered trademark Vivarin®.
    50844        REV1219F22631

    Equate 44-226

    Equate 44-226

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-226
    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 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)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-226-311 in 1 CARTON11/21/1996
    180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34011/21/1996
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(49035-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(49035-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(49035-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(49035-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(49035-226)