Stay Awake Tablet, Coated
FDA Label NDC 83059-0097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Stay Awake (NDC 83059-0097). 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, active ingredient (in each tablet), purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Caffeine 200 mg
Purpose
Alertness aid
Uses
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
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 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. 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 in a dry place at 15° – 30°C (59° – 86°F)
- do not use if imprinted seal under cap is broken or missing
Inactive Ingredients
colloidal silicon dioxide*, crosscarmellose sodium*, D&C yellow # 10*, FD&C yellow # 6, hypermellose*, lactose*, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide*
*contains one or more of these ingredients
Questions Or Comments?
1-800-373-6981(toll-free)
Other
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
Principal Display Panel
Stay Awake
Caffeine 200 mg/ Alertness Aid
- Caffeine for mental alertness
- Equal to about a cup of coffee
Label
* Please review the disclaimer below.
