RxNorm Names
Review RxNorm Normal Forms
STAY AWAKE
(caffeine)
tablet
[Freds Inc]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=29af389e-044b-4415-a81e-5bbe63c21f3f| 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
Inactive ingredients
cellulose*, croscarmellose sodium*, D&C Yellow #10 aluminum lake, dicalcium phosphate, FD&C Yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica, sodium starch glycolate*, starch*
*contains one or more of these ingredients
Principal Display Panel
Stay Awake
Caffeine, 200 mg
Maximum Strength Alertness Aid
Safe & Effective
Compare to the active ingredient in Vivarin®**
DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
**This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Vivarin®.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
TAMPER EVIDENT USE ONLY IF BLISTERS ARE INTACT
| STAY AWAKE
caffeine tablet |
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| Labeler - Freds Inc (005866116) |
| Registrant - P and L Development of New York Corporation (800014821) |
Revised: 02/2013
Document Id: 4a3fc395-654b-4156-9541-4e0918cb4dfb
Set id: 29af389e-044b-4415-a81e-5bbe63c21f3f
Version: 1
Effective Time: 20130213
Freds Inc
