ALERT- caffeine tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Time Cap Labs, Inc

INN (Международно Name):

CAFFEINE

Композиция:

CAFFEINE 200 mg

Начин на приложение:

ORAL

Вид предписание :

OTC DRUG

Терапевтични показания:

Purpose Alertness aid Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness - Do not use in children under 12 years of age as a substitute for sleep Do not use - in children under 12 years of age - as a substitute for sleep Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur

Статус Оторизация:

OTC monograph final

Данни за продукта

ALERT- CAFFEINE TABLET, FILM COATED
TIME CAP LABS, 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._
----------
343R- ALERT
ACTIVE INGREDIENT (IN EACH TABLET)
Caffeine 200 mg
PURPOS E
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 heartbeat.
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
store at 25°C (77°F) excursions permitted between 15°-30°C
(59°-86°F)
avoid excessive heat (greater than 100°F) or humidity
use by expiration date on package
INACTIVE INGREDIENTS
carnauba wax, colloidal silicon dioxide, D-C yellow #10 aluminum lake,
dextrates, FD-C yellow #6
aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol,
titanium dioxide
ALERT
caffeine tablet, film coated
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:49 48 3-343
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)
CAFFEINE
20 0 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CARNAUBA WAX (UNII: R12CBM0 EIZ)
SIL