Vivarin

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:57:58

Label at a glance#

ProductVivarin
Active ingredientCAFFEINE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

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

For occasional use only

Do not use

OTC - DO NOT USE SECTION

  • in children under 12 years
  • as a substitute for sleep

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 and over: take 1 tablet not more often than every 3 to 4 hours

Other information

SPL UNCLASSIFIED SECTION

  • 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
  • do not use if pouch is opened or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call toll-free 1-855-874-0970 8:30am to 5:00pm EST Monday to Friday

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VivarinVivarin

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46017-018-16EA - Each46017-0184b3f4f4b-2aae-420e-b8e7-c26d770f937c12018-07-03
46017-018-40EA - Each46017-0188afc7906-404f-48e2-bc13-5d5d3b0dffec12018-07-03

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67751-16067751-160-01, 67751-160-02
46017-018

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eab01e91-d214-34ab-e053-2995a90acdf45e34ae97-d5e7-4c70-8dec-e0be462bea552022-10-10WarningsExact identifier
spl set id: 5e34ae97-d5e7-4c70-8dec-e0be462bea55

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.