Your browser does not support JavaScript! DROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]
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DROWZ AWAY MAXIMUM STRENGTH (caffeine) tablet
[Care One (American Sales Company)]


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

Use

  • 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
  • * 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

www.care1.com

CareOne

caffeine 200 mg

DROWZ AWAY  MAXIMUM STRENGTH
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-252
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 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 212;212
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-252-162 in 1 CARTON
18 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34008/31/2010
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
 
Care One (American Sales Company)

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