Diurex Ultimate

Diurex Ultimate is an FDA-registered drug product whose active ingredient is CAFFEINE. It is labelled by Kobayashi Healthcare International, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 52389-656, application M027, label effective 20260608. 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: relief temporary, water retention, bloating swelling, full feeling, fatigue associated, menstrual periods. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the relief of temporary: water retention bloating swelling full feeling fatigue associated with the premenstrual and menstrual periods.

Directions Read all package directions and warnings before use. Use only as directed. Adults: Two (2) pills (200 mg maximum strength) every 3 to 4 hours while symptoms persist, not to exceed 8 pills in a 24 hour period. Drink 6 to 8 glasses of water daily. Recommended for use by normally healthy adults only.

Warnings

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 Diurex Ultimate used for?
Uses For the relief of temporary: water retention bloating swelling full feeling fatigue associated with the premenstrual and menstrual periods.

Who makes Diurex Ultimate?
Kobayashi Healthcare International, Inc. is the labeler of record for Diurex Ultimate. 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 Diurex Ultimate 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 Diurex Ultimate 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 Diurex Ultimate 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.