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Alert by Time Cap Labs, Inc

Medically reviewed on November 30, 2017

Dosage form: tablet, film coated
Ingredients: CAFFEINE 200mg
Labeler: Time Cap Labs, Inc
NDC Code: 49483-343

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.

Drug Facts

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

Do not use
  • in children under 12 years of age
  • as a substitute for sleep

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 heart beat.

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

ALERT 
caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-343
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
D&C YELLOW NO. 10 
DEXTRATES 
FD&C YELLOW NO. 6 
HYPROMELLOSE 2910 (6 MPA.S) 
HYPROMELLOSE 2910 (15 MPA.S) 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 8000 
TITANIUM DIOXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeTCL;343
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-343-4440 TABLET, FILM COATED (TABLET) in 1 BOTTLE
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/FEIOperations
Time Cap Labs, Inc037052099manufacture

 
Time Cap Labs, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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