VIVARIN- caffeine tablet 
GlaxoSmithKline Consumer Healthcare LP

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 ingredients (in each tablet)

Caffeine 200mg

Active ingredients (in each caplet)

Caffeine 200mg

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
  • as a substitute for sleep

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

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 (Tablets)

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

Directions (Caplets)

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

Other information

  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide

Questions or comments?

call toll free 1-800-245-1040 weekdays

GlaxoSmithKline

Consumer Healthcare, L.P.

Pittsburgh, PA 15230, Made in the U.S.A.

©2003 GlaxoSmithKline

www.vivarin.com

Vivarin. Making the Most of Every Day.

Tamper Evident Feature: Individually sealed in foil for your protection. Do not use if foil or plastic bubble is torn or punctured.

VIVARIN® and Logo Design, FUNCTIONAL CAFFEINE™ and overall trade dress are trademarks of GlaxoSmithKline

FUNCTIONAL CAFFEINE™

for Mental Alertness

SAFE &EFFECTIVE

One tablet is equal to about a cup of coffee

Caplets and Tabets

FDA APPROVED USES: Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

Vivarin is functional caffeine to help restore mental alertness so you can accomplish all the things you want to do and all the things you need to do.

Principal Display Panel

vivarin ®

CAFFEINE ALERTNESS AID

16 TABLETS

200mg each

2502XE

vivarin tablet 200 mg carton

Principal Display Panel

vivarin®

CAFFEINE ALERTNESS AID

24 CAPLETS

200mg each

2505XD

vivarin caplet 200mg carton

VIVARIN 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0077
Route of AdministrationORALDEA Schedule    
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0077-0716 in 1 BLISTER PACK
2NDC:0135-0077-1340 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34011/08/201008/31/2015
VIVARIN 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0078
Route of AdministrationORALDEA Schedule    
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)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code V
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0078-0924 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34011/08/201009/30/2014
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
Registrant - Meda Consumer Healthcare Inc. (831410522)

Revised: 11/2011
Document Id: db720f5a-ddb9-4c43-9322-c172440ea922
Set id: bf80a778-428c-49d9-a443-f1d7cb688e11
Version: 3
Effective Time: 20111109
 
GlaxoSmithKline Consumer Healthcare LP