FDA Label for Stay Awake
View Indications, Usage & Precautions
Stay Awake Product Label
The following document was submitted to the FDA by the labeler of this product Retail Business Services , Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Active Ingredient (In Each Tablet)
Caffeine 200 mg
Purpose
Alertness aid
Use
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Otc - Do Not Use
For occasional use only
Do not use
- in children under 12 years of age
- as a substitute for sleep
Otc - When Using
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.
Otc - Stop Use
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours
Other Information
- each tablet contains: calcium 80 mg
- store between 20-25°C (68-77°F)
- retain carton for complete product information and warnings
Inactive Ingredients
colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch
Principal Display Panel
NDC 72476-102-01
CAREONE®
Compare to the active ingredient in Vivarin® Tablets†
STAY AWAKE
Caffeine Tablets, 200 mg
Alertness Aid
Safe and Effective
Aids in Mental Alertness
Actual Size
16 TABLETS
* Please review the disclaimer below.