Active Ingredient(S)
Caffeine 200mg
Topcare Stay Awake Tablet, Coated
FDA Label NDC 76162-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Topcare Stay Awake (NDC 76162-002). 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 active ingredient(s), purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Alertness aid
Use
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
For occasional use only.
Do Not Use
- in children under 12 years of age
- as a substitute for sleep
When Using This Product
limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and ocassionally rapid heartbeat.
The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop Use And Ask A Doctor If
fatigue or drowsiness persists or continues to recur
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours
Children under 12 years of age: do not use
Other Information
- store at room temperature 68°-77°F (20°-25°C)
- avoid excessive heat (greater than 100°F) and humidity
- do not use if carton is opened or if blister unit is broken
Inactive Ingredients
croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide
Questions Or Comments?
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Principal Display Panel
Alertness Aid
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