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  5. Label Information: Stay Awake

FDA Label for Stay Awake

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH LIQUID-FILLED CAPSULE)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Stay Awake Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788


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


Otc - 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

Otc - 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.


Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



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


Otc - 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



  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients



  • 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

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


Questions Or Comments?



1-800-373-6981 (toll-free)


Principal Display Panel



Stay Awake

Caffeine 200 mg/ Alertness Aid

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

    • Carton

    Label


* Please review the disclaimer below.