Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Stay Awake
FDA Label NDC 68210-4151
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Stay Awake (NDC 68210-4151). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
