CAREONE STAY AWAKE- caffeine tablet 
American Sales Company

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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American Sales Company Stay Awake 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

For occasional use only

Do not use

in children under 12 years of age
as a substitute for sleep

When using this product

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. 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

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 (1-800-222-1222).

Directions

adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in Vivarin®

STAY AWAKE

Caffeine Tablets 200mg

Alertness Aid

Safe and Effective

Aids in Mental Alertness

OUR PHARMACISTS RECOMMEND

Actual Size

16 TABLETS

stay awake image
CAREONE STAY AWAKE 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-708
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code L409
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-708-7316 in 1 CARTON02/01/2019
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34002/01/2019
Labeler - American Sales Company (809183973)

Revised: 2/2019
Document Id: 5c92de1e-9494-42be-a0b8-0fbc67341209
Set id: 5c92de1e-9494-42be-a0b8-0fbc67341209
Version: 1
Effective Time: 20190207
 
American Sales Company