RxNorm Names
Review RxNorm Normal Forms
DROWZ AWAY MAXIMUM STRENGTH
(caffeine)
tablet
[Care One (American Sales Company)]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=573b7675-10e2-41e1-bbed-76832eacd381| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Warnings
- the recommended dose of this product contains about as much caffeine as one 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.
- For occasional use only. Not intended for use as a substitute for sleep
- do not give to children under 12 years of age
Directions
- adults and children 12 years of age and over: take 1 tablet (200 mg) not more often than every 3 to 4 hours
Other information
- each tablet contains: calcium 60 mg
- store at controlled room temperature 15-30°C (59-86°F)
- avoid excessive heat and humidity
-
* This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Vivarin®
Inactive ingredients
D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose and silica. May also contain: cellulose, croscarmellose sodium, sodium starch glycolate and starch
Principal Display Panel
compare to active ingredient in Vivarin® *
Maximum strength
DROWZ-AWAY
caffeine alertness aid
Each tablet contains 200 mg caffeine equal to about one cup of coffee
TAMPER EVIDENT- USE ONLY IF BLISTERS ARE INTACT
Distributed by: American Sales Company
4201 walden avenue, Lancaster, NY 14086
caffeine 200 mg
| DROWZ AWAY
MAXIMUM STRENGTH
caffeine tablet |
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| Labeler - Care One (American Sales Company) (809183973) |
| Registrant - P and L Development of New York Corporation (800014821) |
Revised: 12/2012
Document Id: d761ce3e-5a9d-43ef-ad95-b1a3d8326c5c
Set id: 573b7675-10e2-41e1-bbed-76832eacd381
Version: 1
Effective Time: 20121228
Care One (American Sales Company)
