Label: ALERTNESS AID 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 7, 2017

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Purpose

    Alertness Aid

  • Active Ingredient (in each tablet)

    Caffeine 200mg

  • Uses

    • Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
  • Warnings

    For occasional use only

    Do not use

    • in children under 12 years of age
    • as a substitute for sleep

    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.

  • 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 c ase 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 than every 3 to 4 hours
  • Other Information 

    • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) or humidity
    • Avoid excessive heat (greater than 100°F) or  humidity
    • Read all product information before using
    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive Ingredients

    • Carnauba wax
    • Colloidal silicon dioxide 
    • D&C yellow #10 aluminium lake
    • Dextrates
    • FD&C yellow#6 aluminium lake
    • Hypeomellose
    • Magnesium stearate
    • Microcrystalline cellulose
    • Polyethylene glycol
    • Titanium dioxide
  • Questions or comments? 

    Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

  • Alertness Aid Stay Awake Caffeine 200mg / alertness AidSafe & Effective Helps Restore Alertness  Compare to Vivarin® active ingredients

    Distributed by:
    Healthlife of USA LLC
    Rahway
    NJ 07065
    www.healthlifeofusa.com

    image description

  • INGREDIENTS AND APPEARANCE
    ALERTNESS AID STAY AWAKE 
    caffeine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTRATES (UNII: G263MI44RU)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-132-161 in 1 CARTON05/31/2017
    116 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34005/31/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Healthlife of USA079656178repack(69517-132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Time Cap Laboratories, Inc.037052099manufacture(69517-132) , pack(69517-132)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!