Drug Facts
Active ingredient (in each tablet)
Caffeine 200mg
Vivarin Tablet
FDA Label NDC 67751-226
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Vivarin (NDC 67751-226). 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, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, 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
Use
Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
Do not use
- as a substitute for sleep. This product is intended for occasional use only.
- in children under 12 years of age
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.
Stop Use And Ask A Doctor If
fatigue or drowsiness persists or continues to recur.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.
Other Information
- each tablet contains calcium 60 mg
- store in a dry place at 15° - 30°C (59° - 86°F)
- avoid excessive heat (greater than 100°F) or humidity
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide
Questions Or Comments?
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Package Label-Principal Display Panel
Made in India
Vivarin (Vivarin 80)
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