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Mucus Relief Dm

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This product has been discontinued

Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 30, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M012
NDC root
68210-1390
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Mucus Relief DM is a medication designed to help you manage symptoms associated with cough and mucus buildup. It contains two active ingredients: guaifenesin (an expectorant) and dextromethorphan HBr (a cough suppressant). Guaifenesin works by loosening phlegm and thinning bronchial secretions, making your coughs more productive. Meanwhile, dextromethorphan helps control your cough, providing relief when you need it most.

This medication dissolves quickly in your system, allowing it to start working effectively to ease your symptoms. Mucus Relief DM is particularly useful for those experiencing discomfort from excessive mucus and coughing, helping you breathe easier and feel more comfortable.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) in your airways. By doing so, it makes your coughs more productive, allowing you to clear out mucus more effectively. If you're dealing with respiratory issues, this can be a helpful option to consider for improving your comfort and breathing.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take one softgel with a full glass of water every four hours as long as your symptoms continue. It's important not to take more than six doses in a 24-hour period to ensure your safety.

For children under 12 years of age, this medication is not recommended, so please avoid using it for younger individuals. Always remember to stay hydrated by drinking a full glass of water with each dose.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

While using this product, it's important to follow the recommended dosage and not exceed it. Also, do not use it for more than seven days. Taking these precautions can help prevent potential complications and ensure your safety.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you have a cough that produces a lot of mucus or a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, consult your doctor before using this product.

While using this medication, it’s crucial not to exceed the recommended dosage or use it for more than seven days. If your cough lasts longer than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the product and seek medical advice, as these may indicate a more serious issue. If you are pregnant or breastfeeding, please consult a healthcare professional before use. Always keep this medication out of reach of children, and in case of accidental overdose, seek medical help immediately.

Warnings and Precautions

If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, you should not use this product. You must wait at least two weeks after stopping an MAOI before taking it. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have a cough that produces a lot of mucus or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. If you accidentally take too much of this product, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your cough lasts more than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to know that this medication is not recommended for children under 12 years of age. If your child is younger than this, you should avoid using it. Always consult with your healthcare provider for guidance on safe treatment options for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's crucial to be aware of potential interactions when taking medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson's disease, you should not take this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, it's important to consult with your doctor or pharmacist.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid harmful interactions. Your health is a priority, and your provider can help you navigate any concerns regarding your treatments.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F), allowing for brief periods between 15° and 30°C (59° and 86°F). It's important to keep the product in a dry location and avoid exposing it to heat, as this can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication with a full glass of water. The recommended dosage is one softgel every four hours while your symptoms persist, but do not exceed six doses in a 24-hour period. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, if you experience any side effects, you can report them by calling 1-888-333-9792.

FAQ

What is Mucus Relief DM?

Mucus Relief DM is a medication that contains GUAIFENESIN 400 mg, an expectorant, and DEXTROMETHORPHAN HBr 20 mg, a cough suppressant. It helps loosen phlegm and control cough.

How should I take Mucus Relief DM?

You should take 1 softgel every 4 hours with a full glass of water while symptoms persist, and do not exceed 6 doses in 24 hours.

Who should not use Mucus Relief DM?

Do not use Mucus Relief DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Additionally, it is not recommended for children under 12 years of age.

What should I do if my cough lasts more than 7 days?

You should stop using Mucus Relief DM and ask a doctor if your cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Is it safe to use Mucus Relief DM during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Mucus Relief DM.

What are the side effects of Mucus Relief DM?

While specific side effects are not listed, you should report any adverse effects to a healthcare provider. If you experience severe symptoms, seek medical help immediately.

How should I store Mucus Relief DM?

Store Mucus Relief DM at 25°C (77°F) with excursions between 15° - 30°C (59° - 86°F) in a dry place, away from heat.

Packaging Info

Below are the non-prescription pack sizes of Mucus Relief Dm (guaifenesin and dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief Dm.
Details

Drug Information (PDF)

This file contains official product information for Mucus Relief Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mucus Relief DM is a combination medication formulated to provide relief from cough and mucus congestion. Each dose contains 400 mg of GUAIFENESIN, an expectorant that aids in thinning and loosening mucus, facilitating easier expectoration. Additionally, it includes 20 mg of DEXTROMETHORPHAN HBr, a cough suppressant that effectively controls cough reflexes. The formulation is designed to dissolve quickly, ensuring prompt action in alleviating symptoms associated with respiratory conditions.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions. It helps loosen phlegm and thins bronchial secretions, thereby enhancing the productivity of coughs.

There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take one softgel every four hours while symptoms persist, accompanied by a full glass of water. It is imperative not to exceed six doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their prescription.

Additionally, the product should not be used in excess of the recommended dosage or for a duration exceeding 7 days.

Warnings and Precautions

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease, should not use this product. This restriction applies during the course of MAOI treatment and for a period of two weeks following the cessation of MAOI therapy. If there is uncertainty regarding the presence of an MAOI in a prescribed medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to seek medical guidance before using this product if they experience a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

In the event of an accidental overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs). The use of this product is contraindicated in patients currently taking MAOIs or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include cough accompanied by excessive phlegm, as well as persistent or chronic coughs associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. It is important for patients to seek medical advice before using this product if they experience these symptoms.

While using this product, patients should adhere to the recommended dosage and avoid using it for more than 7 days. If a cough persists beyond this duration, recurs, or is accompanied by fever, rash, or a persistent headache, patients should discontinue use and consult a healthcare provider, as these symptoms may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is essential to seek guidance from a health professional prior to use. Additionally, this product should be kept out of reach of children, and in the event of an accidental overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Dm (guaifenesin and dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief Dm.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and therefore, its use is contraindicated in children younger than 12.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-888-333-9792.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of an accidental overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, they should refrain from using this product for at least 2 weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with their doctor or pharmacist prior to use.

Healthcare providers should instruct patients to stop using the product and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients must be cautioned not to exceed the recommended dosage and to limit use to no more than 7 days.

Providers should also encourage patients to consult with their doctor before using this product if they have a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F).

It is essential to keep the product in a dry place, ensuring that it is not exposed to heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

Patients should take the medication with a full glass of water, administering 1 softgel every 4 hours as needed while symptoms persist, without exceeding 6 doses in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, patients are encouraged to report any side effects to 1-888-333-9792. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mucus Relief Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mucus Relief Dm, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.