Mucus Relief DM Cough Maximum Strength

DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL HUMAN OTC DRUG

Mucus Relief DM Cough Maximum Strength is an FDA drug label for the active ingredient DEXTROMETHORPHAN HBR AND GUAIFENESIN manufactured by Cardinal Health 110, LLC. DBA Leader 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 20260821.

Generic name
DEXTROMETHORPHAN HBR AND GUAIFENESIN
Manufacturer
Cardinal Health 110, LLC. DBA Leader
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
70000-0278
Application
M012
Label effective
20260821

About this product

Mucus Relief DM Cough Maximum Strength is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR AND GUAIFENESIN. It is labelled by Cardinal Health 110, LLC. DBA Leader taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 70000-0278, application M012, label effective 20260821. It is one of 7 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR AND GUAIFENESIN. 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 DEXTROMETHORPHAN HBR AND GUAIFENESIN are most often described in connection with: helps loosen, phlegm mucus, thin bronchial, secretions rid, passageways bothersome, make coughs, productive temporarily, relieves cough. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients (in each immediate-release tablet) Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation associated with the common cold the intensity of coughing the impulse to cough to help you get to sleep

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over: 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use

Warnings

Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough accompanied by too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema When using this product do not exceed recommended dosage. Stop use and ask a doctor if cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

DEXTROMETHORPHAN HBR AND GUAIFENESIN

CVS Mucus Relief DM Maximum Strength

CVS PHARMACY View label

DRx Choice Children daytime Cough and Chest Congestion

RARITAN PHARMACEUTICALS View label

KROGER Mucus Relief DM Maximum Strength

KROGER COMPANY View label

Mucus Relief DM

ARMY AND AIR FORCE EXCHANGE SERVICE View label

Mucus Relief DM Maximum Strength

WINCO FOODS, LLC View label

Tussin DM Regular

AARNA USA, Inc. View label

How products containing DEXTROMETHORPHAN HBR AND GUAIFENESIN compare

FDA lists 7 drug label records with DEXTROMETHORPHAN HBR AND GUAIFENESIN 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
— — AARNA USA, Inc. 1
— — ARMY AND AIR FORCE EXCHANGE SERVICE 1
— — CVS PHARMACY 1
— — Cardinal Health 110, LLC. DBA Leader 1
— — KROGER COMPANY 1

Frequently asked questions

What is Mucus Relief DM Cough Maximum Strength used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation associated with the common cold the intensity of coughing the impulse to cough to help you get to sleep

Who makes Mucus Relief DM Cough Maximum Strength?
Cardinal Health 110, LLC. DBA Leader is the labeler of record for Mucus Relief DM Cough Maximum Strength. 7 FDA label records share the active ingredient DEXTROMETHORPHAN HBR AND GUAIFENESIN, 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 Mucus Relief DM Cough Maximum Strength 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 Mucus Relief DM Cough Maximum Strength 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 DEXTROMETHORPHAN HBR AND GUAIFENESIN?
Yes. 7 FDA drug label records list DEXTROMETHORPHAN HBR AND GUAIFENESIN 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 Mucus Relief DM Cough Maximum Strength 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.