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Vivarin by Navajo Manufacturing Company Inc.

Dosage form: tablet
Ingredients: CAFFEINE 200mg
Labeler: Navajo Manufacturing Company Inc.
NDC Code: 67751-160

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.

Vivarin

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
  • 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 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
  • do not use if pouch is opened or torn

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 8:30am to 5:00pm EST Monday to Friday

Package Labeling

VIVARIN 
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-160(NDC:46017-018)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (CAFFEINE) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeV
Contains    
Packaging
#Item CodePackage Description
1NDC:67751-160-011 POUCH in 1 CARTON
12 TABLET in 1 POUCH
2NDC:67751-160-021 POUCH in 1 CARTON
24 TABLET in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34009/21/2016
Labeler - Navajo Manufacturing Company Inc. (091917799)

Revised: 09/2016
 
Navajo Manufacturing Company Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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