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 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, 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 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.®

VIVARIN
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46017-012
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46017-012-02	2 in 1 POUCH; Type 0: Not a Combination Product	06/15/2014	09/30/2022
2	NDC:46017-012-04	2 in 1 PACKAGE	06/15/2014	09/30/2022
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	09/30/2022
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	09/30/2022
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	09/30/2022
5	NDC:46017-012-08	8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part340	06/15/2014	09/30/2022

Labeler - Mylan Consumer Healthcare, Inc. (831410522)

Revised: 4/2020

Document Id: 22088e7d-d147-4f99-ae62-c9734b45bf9e

Set id: 587358ab-e28c-11e3-8b68-0800200c9a66

Version: 5

Effective Time: 20200414

Mylan Consumer Healthcare, Inc.