Label: STAY ALERT ALERTNESS AID- caffeine tablet

  • NDC Code(s): 15127-226-10, 15127-226-21
  • Packager: L&R Distributors, 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 June 1, 2019

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

    • 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?

    1-800-426-9391

  • Principal Display Panel

    select brand®
    the lower price name brand

    Alertness Aid
    Stay Alert Tablets

    Caffeine 200 mg
    Equal to About a Cup of Coffee

    *Compare to the Active Ingredient of Vivarin®

    40 TABLETS

    Actual Size

    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             REV0412A22610

    Distributed by:
    SELECT BRAND® DISTRIBUTORS
    Pine Bluff, AR 71603   USA
    AC (870) 535-3635

    SATISFACTION
    GUARANTEED
    select
    brand®

    Select Brand 44-226

    Select Brand 44-226

  • INGREDIENTS AND APPEARANCE
    STAY ALERT  ALERTNESS AID
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-226
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-226-105 in 1 CARTON11/21/199608/03/2021
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:15127-226-212 in 1 CARTON11/21/199608/03/2021
    28 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34011/21/199608/03/2021
    Labeler - L&R Distributors, Inc. (012578514)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(15127-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(15127-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(15127-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(15127-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(15127-226)