Vivarin

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:25

Key Label Information#

Active Ingredients And Purpose

Drug Facts

Active ingredient (in each tablet) Caffeine 200mg

Purpose

Alertness aid

Uses

Use

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

Warnings

Do not use as a substitute for sleep. This product is intended for occasional use only. in children under 12 years of age

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.

Directions And Dosage

Directions

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

Other Label Information

Other information

each tablet contains calcium 60 mg store in a dry place at 15° - 30°C (59° - 86°F) avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

carnauba wax, colloidal silicon dioxide, 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, starch, titanium dioxide

Questions or comments?

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

Made in India

Label Images#

Vivarin-80
Vivarin-80

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198520caffeine 200 MG Oral TabletPSN2
209754VIVARIN 200 MG Oral TabletPSN2
209754caffeine 200 MG Oral Tablet [Vivarin]SBD2
198520caffeine 200 MG Oral TabletSCD2
209754Vivarin 200 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-226-04Vivarin1 in 1 CARTONTABLET12
67751-226-04Vivarin4 in 1 BLISTER PACKTABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-226VIVARIN (CAFFEINE) TABLET [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 2 package rows20241004_1639b0ac-8d6a-e5fe-e063-6294a90aeead.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71179-018-24EA - Each71179-018f803525d-4aa3-4e86-9151-864614111f6012026-05-22

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-22667751-226-04
71179-018

Ingredients#

Complete SPL Sections#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Caffeine 200mg

Purpose

OTC - PURPOSE SECTION

Alertness aid

Use

INDICATIONS & USAGE SECTION

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WARNINGS SECTION

Do not use as a substitute for sleep. This product is intended for occasional use only. in children under 12 years of age

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

fatigue or drowsiness persists or continues to recur.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

each tablet contains calcium 60 mg store in a dry place at 15° - 30°C (59° - 86°F) avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, 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, starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made in India

Source Document#

Source XML