Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Time Cap Labs, Inc
CAFFEINE
CAFFEINE 200 mg
ORAL
OTC DRUG
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
OTC monograph final
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 Soma hati kamili