Label: STAY AWAKE- caffeine tablet, coated

  • NDC Code(s): 83059-0008-1
  • Packager: Shield Pharmaceuticals Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each liquid-filled capsule)

    Caffeine 200 mg

  • Purpose

    Alertness aid

  • Uses

    helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

  • Warnings

  • DO NOT USE

    Do not use

    • as a substitute for sleep. This product is intended for occasional use only.
    • in children under 12 years of age
  • WHEN USING

    When using this productlimit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

  • STOP USE

    Stop use and ask a doctorif fatigue or drowsiness persists or continues to recur.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    adults and children 12 years and over:

    • take 1 tablet not more often than every 3 to 4 hours
  • Other information

    • each tablet contains: calcium 60 mg
    • store in a dry place at 15° – 30°C (59° – 86°F)
    • do not use if imprinted seal under cap is broken or missing
  • Questions or comments?

    1-800-373-6981 (toll-free)

  • Inactive ingredients

    FD&C yellow # 6, magnesium stearate, maize starch, microcrystalline cellulose, povidone, stearic acid, Sodium Starch Glycolate, talc

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Shield Pharmaceuticals Corp.
    Hauppauge, NY 11788

  • PRINCIPAL DISPLAY PANEL

    Stay Awake

    Caffeine 200 mg/ Alertness Aid

    • Caffeine for mental alertness
    • Equal to about a cup of coffee

    Carton

    Stay Awake Carton

    Label

    Stay Awake Label

  • INGREDIENTS AND APPEARANCE
    STAY AWAKE 
    caffeine tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code D4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83059-0008-11 in 1 CARTON01/16/2024
    115 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/16/2024
    Labeler - Shield Pharmaceuticals Corp (118724924)
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