Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Caffeine Tablet
FDA Label NDC 69842-509
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Caffeine (NDC 69842-509). 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, otc - purpose, uses, warnings, do not use, 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
Otc - Purpose
Purpose
Alertness aid
Uses
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
For occasional use only
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.
Do Not Use
■ in children under 12 years ■ as a substitute for sleep
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
Keep out of reach of children
Overdosage
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
■ each tablet contains: calcium 62 mg
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
■ see end flap for expiration date and lot number
Inactive Ingredients
corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica
Questions Or Comments?
1-800-231-4670
Other
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Meda Consumer Healthcare, owner of the registered trademark Vivarin®.
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-34571
Package Label.Principal Display Panel
CVS Health
Compare to the active ingredient in Vivarin®*
Caffeine Tablets
Caffeine,200mg
Alertness aid
• For mental alertness
• Safe & effective
80 Tablets
* Please review the disclaimer below.
