mylanta gas

SIMETHICONE ORAL HUMAN OTC DRUG

mylanta gas is an FDA drug label for the active ingredient SIMETHICONE manufactured by Infirst Healthcare 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 20260501.

Generic name
SIMETHICONE
Manufacturer
Infirst Healthcare
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
62372-554
Application
M002
Label effective
20260501

About this product

mylanta gas is an FDA-registered drug product whose active ingredient is SIMETHICONE. It is labelled by Infirst Healthcare taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 62372-554, application M002, label effective 20260501. 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: 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

Active ingredient (in each softgel) Simethicone 125 mg

Indications & Usage

Uses for the relief of • pressure, bloating and fullness, commonly referred to as gas

Dosage & Administration

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

Warnings

Warnings Keep out of reach of children

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SIMETHICONE

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Anti-Gas

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Anti-Gas

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Best Choice

BEST CHOICE (VALU MERCHANDISERS COMPANY) View label

Best Choice Extra Strength

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CVS Health Anti gas

CVS PHARMACY View label

CVS Health Infant Gas Relief

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CVS PHARMACY Extra Strength

CVS View label

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 mylanta gas used for?
Uses for the relief of • pressure, bloating and fullness, commonly referred to as gas

Who makes mylanta gas?
Infirst Healthcare is the labeler of record for mylanta gas. 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 mylanta 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 mylanta 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?
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 mylanta 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.