Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Caffeine Tablet
FDA Label NDC 69842-500
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 69842-500). 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, otc - do not use, 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
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.
Otc - Do Not Use
Do not use
■ in children under 12 years of age
■ as a substitute for sleep
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 (1-800-222-1222) right away.
Directions
■ adults and children 12 years of age and over: take 1/2 to 1 tablet not more often than every 3 to 4 hours
Other Information
■ each tablet contains: calcium 63 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 Ingredient
corn starch, croscarmellose sodium, dicalcium phosphate, 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
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Maximum Strength NoDoz®.
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
CVSHealth
Compare to the active ingredient in Maximum Strength NoDoz®*
MAXIMUM STRENGTH
Caffeine Tablets
CAFFEINE, 200 mg
Alertness aid
• Easy to swallow
• Fast acting
• Safe & ef fective
60 TABLETS
* Please review the disclaimer below.
