Mylanta One Antacid/Anti-Gas

CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE ORAL HUMAN OTC DRUG

Mylanta One Antacid/Anti-Gas is an FDA drug label for the active ingredient CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE manufactured by Infirst Healthcare 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 20231211.

Generic name
CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE
Manufacturer
Infirst Healthcare Inc.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
62372-551
Application
M001
Label effective
20231211

About this product

Mylanta One Antacid/Anti-Gas is an FDA-registered drug product whose active ingredient is CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE. It is labelled by Infirst Healthcare Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 62372-551, application M001, label effective 20231211. It is one of 2 FDA drug label records sharing the active ingredient CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE. 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 CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE are most often described in connection with: relieves heartburn, acid indigestion, sour stomach, symptoms pressure, bloating commonly, referred gas, overindulgence food. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each tablet) Calcium carbonate 1000mg Magnesium hydroxide 270mg Simethicone 80mg

Indications & Usage

Uses relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas overindulgence in food and drink

Dosage & Administration

Directions adults and children 12 years and over: chew 1 tablet as symptoms occur, or as directed by doctor do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks children under 12 years of age: ask a doctor

Warnings

Warnings Ask a doctor before use if you have kidney disease a magnesium restricted diet Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

How products containing CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE compare

FDA lists 2 drug label records with CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE 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
— — Infirst Healthcare Inc. 2
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Frequently asked questions

What is Mylanta One Antacid/Anti-Gas used for?
Uses relieves: heartburn acid indigestion sour stomach upset stomach due to these symptoms pressure and bloating commonly referred to as gas overindulgence in food and drink

Who makes Mylanta One Antacid/Anti-Gas?
Infirst Healthcare Inc. is the labeler of record for Mylanta One Antacid/Anti-Gas. 2 FDA label records share the active ingredient CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE, 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 One Antacid/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 Mylanta One Antacid/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 CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE?
Yes. 2 FDA drug label records list CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, DIMETHICONE 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 One Antacid/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.