VIVARIN- caffeine tablet

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]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Caffeine 200mg

PURPOSE

Purpose

Alertness aid

INDICATIONS & USAGE

Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

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

SPL UNCLASSIFIED SECTION

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 INGREDIENT

Inactive ingredients

carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, 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

Questions or comments?

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

 

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

VIVARIN 
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46017-012
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)
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
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)
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: 46017-012-02	2 in 1 POUCH; Type 0: Not a Combination Product	06/15/2014
2	NDC: 46017-012-04	2 in 1 PACKAGE	06/15/2014
2	NDC: 46017-012-02	2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 46017-012-06	3 in 1 PACKAGE	06/15/2014
3	NDC: 46017-012-02	2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 46017-012-16	2 in 1 CARTON	06/15/2014
4	NDC: 46017-012-08	8 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC: 46017-012-40	5 in 1 CARTON	06/15/2014
5	NDC: 46017-012-08	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	06/15/2014

Labeler - Mylan Consumer Healthcare, Inc. (831410522)