FDA Label for Stay Awake

View Indications, Usage & Precautions

Stay Awake Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.

Drug Facts



Active ingredient (in each tablet)                                                                  
Caffeine 200 mg


Purpose



Alertness Aid


Indications & Usage



Use

■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness


Warnings



Warnings

For occasional use only

Do not use

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


Otc - When Using



When using this product limit 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 doctor if 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.


Overdosage



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


Dosage & Administration



Directions

■ adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.


Other



Other information

■ store at room temperature
■ avoid excessive heat (greater than 100°F) or humidity


Inactive Ingredient



carnauba wax*,croscarmellose sodium, colloidal silicon
dioxide*, dextrates*, D&C yellow #10 aluminum lake,
dicalcium phosphate*, FD&C red#40 lake*, FD&C yellow
#6 aluminum lake*, hypromellose, lactose*, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
silicon dioxide*, titanium dioxide
*contains one or more of these ingredients


Otc - Questions



Questions or comments?

1-888-333-9792


* Please review the disclaimer below.