FDA Label for Caffeine
View Indications, Usage & Precautions
Caffeine Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each tablet)
Caffeine 200mg
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
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.
