Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
National Distribution Network (Smart Choice)
CAFFEINE
CAFFEINE 200 mg
OTC DRUG
OTC monograph final
STAY AWAKE- CAFFEINE TABLET NATIONAL DISTRIBUTION NETWORK (SMART CHOICE) _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._ ---------- 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 20°-25°C (68°-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 Actve Ingredient in VIVARIN®* Caffeine, 200 mg STAY AWAKE Maximum Strength Alertness Aid Equal to about 1 cup of coffee Safe & Effective Tablets *This product is not manufactured or distributed by Meda Consumer Healthcare, distributor of Vivarin®. DISTRIBUTED BY: NATIONAL DISTRIBUTION NETWORK P.O. BOX 875 MELVILLE, NY, 11747-0875 TAMPER EVIDENT: DO NOT USE Read the complete document