Drugplain

Stay Awake 200 mg/1

Caffeine · TABLET, COATED · Shield Pharmaceuticals Corp

No Recall History
Plain English

Stay Awake is an over-the-counter tablet containing 200 mg of caffeine that you take by mouth to help restore mental alertness and reduce fatigue. As a central nervous system stimulant, it works by increasing wakefulness when you're feeling drowsy.

Key Facts

Brand Name
Stay Awake
Generic Name
Caffeine
NDC Code (Product)
83059-0008
Manufacturer
Shield Pharmaceuticals Corp
Strength
200 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
505G(a)(3)
Drug Class
Central Nervous System Stimulant [EPC]; Methylxanthine [EPC]
Marketing Start
01/16/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents1,358 reports
fatigue1,241 reports
pain1,131 reports
off label use1,084 reports
alopecia1,059 reports
arthralgia1,055 reports
vomiting1,041 reports
drug ineffective1,036 reports
abdominal discomfort1,030 reports
condition aggravated1,028 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage & Administration

Directions adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours children under 12 years: do not use

Warnings

Warnings For occasional use only 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 heart beat. Do not use for 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. 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.

Frequently Asked Questions

What is Stay Awake used for?

Stay Awake is an over-the-counter tablet containing 200 mg of caffeine that you take by mouth to help restore mental alertness and reduce fatigue. As a central nervous system stimulant, it works by increasing wakefulness when you're feeling drowsy.

Is Stay Awake a controlled substance?

Stay Awake is not classified as a controlled substance by the DEA.

What is the generic name for Stay Awake?

The generic name for Stay Awake is Caffeine. There are 9 other brand versions of Caffeine.

What is the NDC code for Stay Awake 200 mg/1?

The NDC (National Drug Code) for Stay Awake 200 mg/1 is 83059-0008, listed by Shield Pharmaceuticals Corp.

Product NDC

83059-0008

Package NDC

83059-0008-1

Other Caffeine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)