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Stay Awake by Chain Drug Marketing Association

Medically reviewed on October 30, 2017

Dosage form: tablet
Ingredients: CAFFEINE 200mg
Labeler: Chain Drug Marketing Association
NDC Code: 63868-109

Disclaimer: 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.

1020 - QCH - 2014-1028

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

Do not use 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

For occasional use only. Not intended as a substitute for sleep.

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 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 80 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dibasic calcium phosphate, FD&C yellow #6, magnesium stearate, microcrystalline cellulose, pregelatinized starch

PRINCIPAL DISPLAY PANEL

NDC 63868-109-16

QUALITY CHOICE

†Compare to Active Ingredient in VIVARIN®

Stay Awake

Alertness Aid

Caffeine, 200 mg

Safe and Effective

16 Tablets – 200 mg each

STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-109
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeLL64;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-109-162 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34006/13/2014
Labeler - Chain Drug Marketing Association (011920774)

 
Chain Drug Marketing Association

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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