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Vivarin by Meda Consumer Healthcare Inc.

Dosage form: tablet
Ingredients: CAFFEINE 200mg
Labeler: Meda Consumer Healthcare Inc.
NDC Code: 46017-012

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 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 of age
  • 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

  • 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 65 mg
  • store at room temperature 20°-25°C (68°-77°F)
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

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

Questions or comments?

Call toll-free 1-855-874-0970 weekdays

 

Display Panel Vivarin (CPC Formulation): 40 ct. Package

SAFE & EFFECTIVE

FUNCTIONAL CAFFEINE® for Mental Alertness

VIVARIN®
CAFFEINE ALERTNESS AID

40 Tablets
200 mg each

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

FUNCTIONAL CAFFEINE® for Mental Alertness

VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.

Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL CAFFEINE® are registered trademarks of Meda AB.

Vivarin®
Making the Most of Every Day.®

Distributed by:
Meda Consumer Healthcare Inc.
Atlanta, GA 30339 ©2014 Meda AB
www.vivarin.com

VIVARIN 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46017-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
CARNAUBA WAX 
COLLOIDAL SILICON DIOXIDE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeV
Contains    
Packaging
#Item CodePackage Description
1NDC:46017-012-022 TABLET in 1 POUCH
2NDC:46017-012-042 POUCH in 1 PACKAGE
2NDC:46017-012-022 TABLET in 1 POUCH
3NDC:46017-012-063 POUCH in 1 PACKAGE
3NDC:46017-012-022 TABLET in 1 POUCH
4NDC:46017-012-162 BLISTER PACK in 1 CARTON
4NDC:46017-012-088 TABLET in 1 BLISTER PACK
5NDC:46017-012-405 BLISTER PACK in 1 CARTON
5NDC:46017-012-088 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34006/15/2014
Labeler - Meda Consumer Healthcare Inc. (831410522)

Revised: 05/2014
 
Meda Consumer Healthcare Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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