Stay Awake Maximum Strength

Stay Awake Maximum Strength is an FDA-registered drug product whose active ingredient is CAFFEINE. It is labelled by United Natural Foods, Inc. dba UNFI taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 41163-434, application M011, label effective 20260615. It is one of 16 FDA drug label records sharing the active ingredient CAFFEINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CAFFEINE are most often described in connection with: helps restore, mental alertness, experiencing fatigue. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions adults and children 12 years and over: take ½ to 1 caplet not more often than every 3 to 4 hours children under 12 years: do not use

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.

FDA lists 16 drug label records with CAFFEINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Stay Awake Maximum Strength used for?
Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Who makes Stay Awake Maximum Strength?
United Natural Foods, Inc. dba UNFI is the labeler of record for Stay Awake Maximum Strength. 16 FDA label records share the active ingredient CAFFEINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Stay Awake Maximum Strength come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Stay Awake Maximum Strength prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CAFFEINE?
Yes. 16 FDA drug label records list CAFFEINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Stay Awake Maximum Strength been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.