VIVARIN- caffeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Mylan Consumer Healthcare, Inc.

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 200 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Alertness aid Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Authorization status:

OTC monograph final

Summary of Product characteristics

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
•
•
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_
•
•
•
_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
in children under 12 years of age
as a substitute for sleep
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
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