Label: ALERT AID- 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 April 16, 2019

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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 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 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, 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

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    Neighbor
    Pharmacy®

    Compare to Vivarin® active ingredient*

    NDC 46122-457-73

    Alert Aid
    caffeine 200 mg

    Alertness Aid

    Maximum Strength

    Equal to about a cup of coffee

    16 Tablets | 200 mg Each

    Actual Size

    • Helps restore mental alertness
    • Equal to about a cup of coffee

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

    RETAIN CARTON FOR COMPLETE
    PRODUCT INFORMATION

    *This product is not manufactured or distributed
    by Meda Consumer Healthcare, owner of the
    registered trademark Vivarin®.  50844   REV0412A22621

    Distributed By
    AmerisourceBergen
    1300 Morris Drive
    Chesterbrook, PA 19087
    Questions or Concerns?
    www.mygnp.com

    GNP 44-226

    GNP 44-226

  • INGREDIENTS AND APPEARANCE
    ALERT AID 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-457
    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 (UNII: 35SW5USQ3G)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    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:46122-457-732 in 1 CARTON11/21/1996
    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 FINALpart34011/21/1996
    Labeler - Amerisource Bergen (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(46122-457)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(46122-457)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(46122-457)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(46122-457)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(46122-457)