Vivarin by Mylan Consumer Healthcare, Inc. Drug Facts

Vivarin by

Drug Labeling and Warnings

Vivarin by is a Otc medication manufactured, distributed, or labeled by Mylan Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VIVARIN- caffeine tablet 
Mylan Consumer Healthcare, 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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Drug Facts

Active ingredient (in each tablet)

Caffeine 200mg

Purpose

Alertness aid

Use

• 1. helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

• 1. in children under 12 years of age
• 2. 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

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

Other information

• 1. store at room temperature
• 2. 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, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide

Questions or comments?

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

 

Display Panel Vivarin: 40 ct. Package

SAFE & EFFECTIVE

FUNCTIONAL CAFFEINE® for Mental Alertness

VIVARIN®
CAFFEINE ALERTNESS AID

•   40 Tablets
  200mg each

FUNCTIONAL CAFFEINE® for Mental Alertness

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

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.

Made in the U.S.A.

•   Vivarin®
  Making the Most of Every Day.®
•   Distributed by:
  Meda Consumer Healthcare Inc.
  Marietta, GA 30062 ©2013 Meda AB
  www.vivarin.com

VIVARIN 
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-018
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	V
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46017-018-02	2 in 1 POUCH; Type 0: Not a Combination Product	01/15/2012	12/31/2019
2	NDC: 46017-018-04	2 in 1 PACKAGE	01/15/2012	12/31/2019
2	NDC: 46017-018-02	2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 46017-018-06	3 in 1 PACKAGE	01/15/2012	12/31/2019
3	NDC: 46017-018-02	2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 46017-018-16	2 in 1 CARTON	01/15/2012	12/31/2019
4	NDC: 46017-018-08	8 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 46017-018-40	5 in 1 CARTON	01/15/2012	12/31/2019
5	NDC: 46017-018-08	8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part340	01/15/2012	12/31/2019

Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 5/2014

Document Id: 4594d088-832b-4b17-b003-42790455bb3a

34390-5

Set id: 4c561b00-c4cf-11df-851a-0800200c9a66

Version: 5

Effective Time: 20140501

 

Mylan Consumer Healthcare, Inc.