STAY AWAKE- caffeine tablet 
Chain Drug Marketing Association

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.

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1020 - QCH - 2019-1004

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

16 Count

STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint Code LL64;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-109-162 in 1 CARTON06/13/201410/31/2017
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34006/13/201410/31/2017
Labeler - Chain Drug Marketing Association (011920774)

Revised: 10/2019
 
Chain Drug Marketing Association