Gas Relief Mint Flavor

SIMETHICONE ORAL HUMAN OTC DRUG

Gas Relief Mint Flavor is an FDA drug label for the active ingredient SIMETHICONE manufactured by Raritan Pharmaceuticals Inc 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 20260908.

Generic name
SIMETHICONE
Manufacturer
Raritan Pharmaceuticals Inc
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
68163-111
Application
M002
Label effective
20260908

About this product

Gas Relief Mint Flavor is an FDA-registered drug product whose active ingredient is SIMETHICONE. It is labelled by Raritan Pharmaceuticals Inc taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68163-111, application M002, label effective 20260908. 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.

What it is used for

Across FDA labelling, products containing SIMETHICONE are most often described in connection with: relieves bloating, pressure symptoms, referred gas. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each tablet) Simethicone 80 mg

Indications & Usage

Uses Relieves: • bloating • pressure • symptoms referred to as gas

Dosage & Administration

Directions • thoroughly chew 1 to 2 tablets as needed after meals and at bedtime • do not exceed 4 tablets in 24 hours period except under the advice and supervision of a physician.

Warnings

Warnings Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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How products containing SIMETHICONE compare

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.

Dosage formProductsManufacturerProducts
— — Allegiant Health 3
— — Advance Pharmaceutical Inc. 2
— — BEST CHOICE (VALU MERCHANDISERS COMPANY) 2
— — C.B. Fleet Company, Inc. 2
— — CVS 2

Frequently asked questions

What is Gas Relief Mint Flavor used for?
Uses Relieves: • bloating • pressure • symptoms referred to as gas

Who makes Gas Relief Mint Flavor?
Raritan Pharmaceuticals Inc is the labeler of record for Gas Relief Mint Flavor. 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 Gas Relief Mint Flavor 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 Gas Relief Mint Flavor 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 Gas Relief Mint Flavor 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.