Simethicone 125MG Gas Relief

Simethicone 125MG Gas Relief is an FDA-registered drug product whose active ingredient is SIMETHICONE 125 MG. It is labelled by One2Zee Limited Liability Company taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55629-021, application M, label effective 20260904. It is one of 2 FDA drug label records sharing the active ingredient SIMETHICONE 125 MG. 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 125 MG are most often described in connection with: relief pressure, bloating fullness, commonly referred. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use for the relief of pressure bloating fullness commonly referred to as gas

Directions adults:swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Warning Keep out of reach of children

FDA lists 2 drug label records with SIMETHICONE 125 MG 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 Simethicone 125MG Gas Relief used for?
Use for the relief of pressure bloating fullness commonly referred to as gas

Who makes Simethicone 125MG Gas Relief?
One2Zee Limited Liability Company is the labeler of record for Simethicone 125MG Gas Relief. 2 FDA label records share the active ingredient SIMETHICONE 125 MG, 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 Simethicone 125MG Gas Relief 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 Simethicone 125MG Gas Relief 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 125 MG?
Yes. 2 FDA drug label records list SIMETHICONE 125 MG 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 Simethicone 125MG Gas Relief 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.