Drug Facts
Active ingredient (in each tablet)
Caffeine 200mg
Caffeine Tablet
FDA Label NDC 58602-747
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Caffeine (NDC 58602-747). 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 (1-800-222-1222) 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
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, corn starch, titanium dioxide
Questions Or Comments?
Call 1-855-274-4122
Distributed by:
Aurohealth LLC.
279 Princeton-Hightstown Road,
East Windsor, NJ 08520
Made in India
Code: TS/DRUGS/16/2014
Package Label-Principal Display Panel 200 Mg (40 Tablets Blister Carton)
AUROHEALTH Package Label-principal Display Panel 200 mg (16 Tablets Container Carton) (Caffeine Fig1)
NDC 58602-747-47
Compare to the active
ingredient in Vivarin®*
CAFFEINE TABLETS 200 mg
ALERTNESS AID
EQUAL TO ABOUT
A CUP OF COFFEE
40 Tablets/200 mg Each 
* Please review the disclaimer below.
