ALERTNESS AID- caffeine tablets, 200 mg tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

We Care Distributor Inc.

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 200 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Authorization status:

OTC monograph final

Summary of Product characteristics

ALERTNESS AID - CAFFEINE TABLETS, 200 MG TABLET, COATED
WE CARE DISTRIBUTOR 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._
----------
ALERTNESS AID - CAFFEINE TABLETS, 200 MG
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH TABLET) PURPOSE
Caffeine 200 mg........................................Alertness aid
US ES
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
CAFFEINE WARNING
the recommended dose of this product contains about as much caffeine
as a cup of coffee. Limit the use
of caffeine-containing medications, foods, or beverages while taking
this product because too much
caffeine may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heart beat.
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 or over: take 1 tablet not
more often than every 3 to 4 hours
OTHER INFORMATION
■ store at 25°C (77°F) excursions permitted between 15°-30°C
(59°-86°F)
■ avoid excessive heat (greater than 100°F) or humidity
INACTIVE INGREDIENTS
carnauba wax, colloidal silicon dioxide, D&C yellow no10 aluminum
lake, dextrates, FD&C yellow
no 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene
glycol, titanium dioxide
glycol, titanium dioxide
QUESTIONS OR COMMENTS?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
PRINCIPAL DISPLAY PANEL
COMPARE TO THE ACTIVE INGREDIENTS IN VIVARIN®
ALERTNESS AID
_CAFFEINE TABLETS, 200 MG_
TO OPEN
PUSH IN TAB AND PULL OUT
_25 POUCHES OF 2 TABLETS E