STAY AWAKE- caffeine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Freds Inc

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 200 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Alertness aid Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness.

Authorization status:

OTC monograph final

Summary of Product characteristics

STAY AWAKE- CAFFEINE TABLET
FREDS 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 200 mg
PURPOS E
Alertness aid
US E
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
WHEN USING THIS PRODUCT,
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
each tablet contains: CALCIUM 60 MG
store at controlled room temperature 20º-25°C (68º-77°F)
avoid excessive heat and humidity
INACTIVE INGREDIENTS
D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6
aluminum lake, magnesium
stearate, microcrystalline cellulose, silica, starch
QUESTIONS OR COMMENTS?
Call 1-877-753-3935 MONDAY-FRIDAY 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
Compare to the active ingredient in Vivarin®*
STAY AWAKE
Caffeine, 200 mg
Maximum Strength Alertness Aid
Safe & Effective
Tablets
*This product is not manufactured or distributed by Meda Consumer
Healthcare, distributor of
Vivarin®.
DISTRIBUTED BY: FRED'S, INC.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
WWW.FREDS INC.COM
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS
TORN, BROKEN OR SHO