Firstcare Gas Relief Simethicone 125 mg Anti-gas
Firstcare Gas Relief Simethicone 125 mg Anti-gas is an FDA drug label for the active ingredient SIMETHICONE 125 MG manufactured by USpharma Ltd administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260512.
- Generic name
- SIMETHICONE 125 MG
- Manufacturer
- USpharma Ltd
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 71594-709
- Application
- M002
- Label effective
- 20260512
About this product
Firstcare Gas Relief Simethicone 125 mg Anti-gas is an FDA-registered drug product whose active ingredient is SIMETHICONE 125 MG. It is labelled by USpharma Ltd taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 71594-709, application M002, label effective 20260512. 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.
What it is used for
Across FDA labelling, products containing SIMETHICONE 125 MG are most often described in connection with: relief pressure, fullness commonly, referred gas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for the relief of pressure, bloating, and fullness commonly referred to as gas
Dosage & Administration
Directions adults and children 12 years and older: take 1 or 2 chewables as needed after meals and at bedtime. do not exceed 4 chewables in 24 hours except under the advice and supervision of a physician.
Warnings
Warnings Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
More products with the same ingredient
SIMETHICONE 125 MGHow products containing SIMETHICONE 125 MG compare
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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | One2Zee Limited Liability Company | 1 |
| — | — | USpharma Ltd | 1 |
| — | — | — | — |
| — | — | — | — |
| — | — | — | — |
Frequently asked questions
What is Firstcare Gas Relief Simethicone 125 mg Anti-gas used for?
Uses for the relief of pressure, bloating, and fullness commonly referred to as gas
Who makes Firstcare Gas Relief Simethicone 125 mg Anti-gas?
USpharma Ltd is the labeler of record for Firstcare Gas Relief Simethicone 125 mg Anti-gas. 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 Firstcare Gas Relief Simethicone 125 mg Anti-gas 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 Firstcare Gas Relief Simethicone 125 mg Anti-gas 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 Firstcare Gas Relief Simethicone 125 mg Anti-gas 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.