Stay Awake
Stay Awake is an FDA drug label for the active ingredient CAFFEINE manufactured by Allegiant Health administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20190108.
- Generic name
- CAFFEINE
- Manufacturer
- Allegiant Health
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69168-076
- Application
- M011
- Label effective
- 20190108
Active ingredients
Indications & Usage
Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Dosage & Administration
Directions Adults and children 12 years of age and older: take 1 tablet not more than every 3 to 4 hours Children under 12 years of age: do not use
Contraindications
Not available.
Warnings
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 because too much caffeine may cause nervousness, irritability, sleep- lessness, and ocassionally 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 or continues to occur. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, contact a doctor or Poison Control Center right away (1-800-222-1222).
Adverse Reactions
Not available.