Label: ALERTNESS AID- caffeine tablet

  • NDC Code(s): 68016-680-16, 68016-680-40
  • Packager: Chain Drug Consortium
  • 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 March 2, 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    • 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

    Premier
    Value®

    *COMPARE TO THE ACTIVE INGREDIENT
    IN VIVARIN®

    Alertness Aid

    Caffeine 200 mg
    ALERTNESS AID

    Equal to about a cup of coffee

    40 Tablets

    Actual Size

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    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®.
    50844                REV1219A22610

    Distributed By:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue,
    Wayne, PA 19087

    If for any reason you are not satisfied with
    this product, please return it to the store
    where purchased for a full refund.

    44-226

    44-226

  • INGREDIENTS AND APPEARANCE
    ALERTNESS AID 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-680
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    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:68016-680-162 in 1 CARTON11/21/1996
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:68016-680-405 in 1 CARTON11/21/1996
    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 FINALpart34011/21/1996
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(68016-680)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(68016-680)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(68016-680)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(68016-680)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(68016-680)