Label: ALERT ALERTNESS AID- caffeine tablet

  • NDC Code(s): 50844-226-12, 50844-226-21
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 8, 2023

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  • 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
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • use by expiration date on package
  • 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

    QUALITY
    PLUS

    NDC 50844-226-12

    *Compare to active ingredient
    in VIVARIN®

    ALERT TABLETS
    Caffeine 200 mg

    ALERTNESS AID

    Equal to about a cup of coffee

    100 Tablets

    ACTUAL SIZE

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

    *This product is not manufactured or distributed by Vespyr Brands, Inc.,
    owner of the registered trademark Vivarin®.
    50844                 REV1219A22612

    Distributed by LNK INTERNATIONAL, INC.
    60 Arkay Drive, Hauppauge, NY 11788
    USA

    Quality Plus 44-226

    Quality Plus 44-226

  • INGREDIENTS AND APPEARANCE
    ALERT  ALERTNESS AID
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-226
    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)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-226-12100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/1996
    2NDC:50844-226-212 in 1 CARTON11/21/199603/04/2022
    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 DrugM01111/21/1996
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(50844-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(50844-226) , pack(50844-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(50844-226)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(50844-226)
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