ALERT- caffeine tablet, film coated 
Time Cap Labs, Inc

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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343R- ALERT

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose


Alertness aid

Uses


helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Caffeine warning:

The recommended dose of this product contains about as much

caffeine

as a 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.

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.

Directions

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

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive heat (greater than 100°F) or humidity
  • use by expiration date on package

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D-C yellow #10 aluminum lake, dextrates, FD-C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

IMAGE OF BOTTLE LABEL
ALERT 
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-343
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTRATES (UNII: G263MI44RU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL;343
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-343-4440 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34011/30/2011
Labeler - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Labs, Inc037052099manufacture(49483-343)

Revised: 12/2018
Document Id: 7d3e5e3c-3199-5637-e053-2991aa0a0d27
Set id: d221f66d-06bb-44e8-a01b-f5919f5c52d2
Version: 2
Effective Time: 20181217
 
Time Cap Labs, Inc