Phazyme Ultimate

Phazyme Ultimate is an FDA-registered drug product whose active ingredient is SIMETHICONE. It is labelled by C.B. Fleet Company, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0132-0222, application M002, label effective 20260520. It is one of 57 FDA drug label records sharing the active ingredient SIMETHICONE. 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 SIMETHICONE are most often described in connection with: relieves bloating, pressure fullness, commonly referred. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use Relieves bloating, pressure or fullness commonly referred to as gas.

Directions Swallow (1) Fast Gel as symptoms occur. Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician

Warnings Stop use and ask a doctor if condition persists.

FDA lists 57 drug label records with SIMETHICONE 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 Phazyme Ultimate used for?
Use Relieves bloating, pressure or fullness commonly referred to as gas.

Who makes Phazyme Ultimate?
C.B. Fleet Company, Inc. is the labeler of record for Phazyme Ultimate. 57 FDA label records share the active ingredient SIMETHICONE, 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 Phazyme 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 Phazyme 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 SIMETHICONE?
Yes. 57 FDA drug label records list SIMETHICONE 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 Phazyme 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.