Mucus Relief DM Cough

DEXTROMETHORPHAN HBR, GUAIFENESIN ORAL HUMAN OTC DRUG

Mucus Relief DM Cough is an FDA drug label for the active ingredient DEXTROMETHORPHAN HBR, GUAIFENESIN manufactured by Amerisource Bergen 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 20260716.

Generic name
DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer
Amerisource Bergen
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
46122-790
Application
M012
Label effective
20260716

About this product

Mucus Relief DM Cough is an FDA-registered drug product whose active ingredient is DEXTROMETHORPHAN HBR, GUAIFENESIN. It is labelled by Amerisource Bergen taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 46122-790, application M012, label effective 20260716. It is one of 33 FDA drug label records sharing the active ingredient DEXTROMETHORPHAN HBR, 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, 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 take with a full glass of water 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 7 days, 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.

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How products containing DEXTROMETHORPHAN HBR, GUAIFENESIN compare

FDA lists 33 drug label records with DEXTROMETHORPHAN HBR, 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
— — CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 4
— — Akron Pharma Inc. 2
— — Amerisource Bergen 2
— — CVS PHARMACY 2
— — DOLGENCORP, LLC 2

Recall and safety notices

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1066-2013 Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22 AmeriSource Bergen Class II Terminated 20131009
D-1065-2013 Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 AmeriSource Bergen Class II Terminated 20131009

Frequently asked questions

What is Mucus Relief DM Cough 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?
Amerisource Bergen is the labeler of record for Mucus Relief DM Cough. 33 FDA label records share the active ingredient DEXTROMETHORPHAN HBR, 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 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 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, GUAIFENESIN?
Yes. 33 FDA drug label records list DEXTROMETHORPHAN HBR, 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 been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.