Your browser does not support JavaScript! STAY AWAKE (CAFFEINE) TABLET [FREDS INC]
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RxNorm Names

STAY AWAKE (caffeine) tablet
[Freds Inc]


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.
Drug Label Sections

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Uses

  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

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

Stop use and ask a doctor if

fatigue or drowsiness persists or continues to recur.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

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

www.fredsinc.com

**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

Package Label

Caffeine, 200 mg

fred's Stay Awake Tablets

 

STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-250
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
POWDERED CELLULOSE 
CROSCARMELLOSE SODIUM 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STARCH, CORN 
ALUMINUM OXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 212;212
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-250-162 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34003/01/2013
Labeler - Freds Inc (005866116)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 2/2013
 
Freds Inc

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