JET ALERT REGULAR STRENGTH- caffeine tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bell Pharmaceuticals, Inc

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 100 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Alertness Aid helps to restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

Authorization status:

OTC monograph final

Summary of Product characteristics

JET ALERT REGULAR STRENGTH- CAFFEINE TABLET, COATED
BELL PHARMACEUTICALS, INC
----------
JET-ALERT REGULAR STRENGTH
_ACTIVE INGREDIENT (IN EACH TABLET)_
Caffeine 100 mg
_PURPOSE_
Alertness Aid
_USES_
helps to 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
WHEN USING THIS PRODUCT
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. 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 • 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.
_DIRECTIONS_
take 1 tablet not more often than every 3 to 4 hours. • ADULTS AND
CHILDREN 12 YEARS
OF AGE AND OVER:
_OTHER INFORMATION_
• store at room temperature between 59°-86°F (15°-30°C) •
protect from excessive
moisture • do not use if tamper-evident seal is broken or missing
INACTIVE INGREDIENTS
calcium stearate, lactose, microcrystalline cellulose, silicon
dioxide.
_QUESTIONS?_
1-800-328-5890
Weekdays 8:30-5:00 CST
PACKAGE LABELING:
PACKAGE LABELING:
JET ALERT REGULAR STRENGTH
caffeine tablet, coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:15579-201
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
CAFFEINE
100 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CALCIUM STEARATE (UNII: 776XM7047L)
Bell Pharmaceuticals, Inc
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PRODUCT CHARACTERISTICS
COLOR
white
SCORE
no score
SHAPE
ROU