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Guaifenesin/Dextromethorphan hydrobromide

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Active ingredients
  • Guaifenesin 1200 mg
  • Dextromethorphan Hydrobromide 60 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet, Extended Release
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
January 30, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 1200 mg
  • Dextromethorphan Hydrobromide 60 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet, Extended Release
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
January 30, 2026
Manufacturer
Aurohealth LLC
Registration number
ANDA206941
NDC root
58602-849
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Mucus Relief DM is a medication designed to help you manage cough and chest congestion. It contains two active ingredients: Dextromethorphan HBr, which acts as a cough suppressant to reduce the urge to cough, and Guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination makes it easier for you to clear mucus from your airways, allowing for more productive coughing and relief from irritation caused by conditions like the common cold or inhaled irritants.

Formulated as extended-release tablets, Mucus Relief DM provides maximum strength relief, helping to alleviate coughing and improve your comfort, especially at night when you may need to sleep better.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your airways, making your coughs more productive.

You can use this medication to temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It also helps reduce the intensity of your cough and can lessen the urge to cough, making it easier for you to get a good night's sleep.

Dosage and Administration

When taking this medication, it's important to swallow the extended-release tablet whole. Do not crush, chew, or break it, as this can affect how the medication works. Make sure to take it with a full glass of water, and you can take it at any time, regardless of meals.

For adults and children aged 12 years and older, the recommended dosage is one extended-release tablet every 12 hours. You should not take more than two tablets in a 24-hour period. If you have children under 12 years old, this medication is not suitable for them, so please avoid using it for that age group.

What to Avoid

It's important to follow the instructions provided with your medication carefully. You should not use more than the directed amount, as taking more than recommended can lead to unwanted effects. Always adhere to the prescribed dosage to ensure your safety and the effectiveness of the treatment.

If you have any questions or concerns about your medication, don't hesitate to reach out to your healthcare provider for guidance. Your health and well-being are the top priority.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. Additionally, if you are currently taking or have recently stopped a prescription monoamine oxidase inhibitor (MAOI)—a type of medication used for depression or certain other conditions—you should avoid using this product.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it’s important to stop using the medication and consult a doctor, as these may indicate a more serious health issue. Before using this product, talk to your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces excessive mucus.

Warnings and Precautions

You should not use this medication if you are under 12 years old. Additionally, avoid it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. It's also important to stop using this medication and call your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach 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 discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older advised to take one extended-release tablet every 12 hours, not exceeding two tablets in a 24-hour period. If you are under 12 years old, do not use this medication.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Always keep it out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Mucus Relief DM?

Mucus Relief DM is a medication that contains Dextromethorphan HBr (60 mg) as a cough suppressant and Guaifenesin (1200 mg) as an expectorant, formulated as extended-release tablets.

How does Mucus Relief DM work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive, while temporarily relieving cough due to minor throat and bronchial irritation.

Who can use Mucus Relief DM?

Adults and children 12 years and older can use it, but it should not be used by children under 12 years of age.

What is the recommended dosage for adults?

The recommended dosage for adults and children 12 years and older is 1 extended-release tablet every 12 hours, not exceeding 2 tablets in 24 hours.

Are there any warnings for using Mucus Relief DM?

Yes, do not use it if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Also, consult a doctor if you have a persistent cough or if your cough lasts more than 7 days.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Can I take Mucus Relief DM if I am pregnant or breastfeeding?

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

How should I take Mucus Relief DM?

Take the extended-release tablet with a full glass of water and do not crush, chew, or break the tablet.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin and Dextromethorphan Hbr. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin and Dextromethorphan Hbr.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin and Dextromethorphan Hbr, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may assist patients in achieving restful sleep.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

The extended-release tablet should be taken with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken, as this may affect the release mechanism of the medication.

For adults and children aged 12 years and older, the recommended dosage is one extended-release tablet every 12 hours. The total daily dosage should not exceed two extended-release tablets within a 24-hour period. This medication can be administered without regard to the timing of meals.

Use of this product is not recommended for children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not prescribed to this age group to avoid potential adverse effects.

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. Additionally, it is essential to refrain from using this medication for at least two weeks after discontinuing an MAOI. If there is any uncertainty regarding the presence of an MAOI in a patient's current prescription regimen, it is imperative to consult a healthcare provider or pharmacist prior to administration.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this medication. Serious adverse reactions may occur, and it is crucial to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

This medication is contraindicated in children under 12 years of age. Additionally, it should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications. Patients are advised to consult a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin and Dextromethorphan Hbr. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin and Dextromethorphan Hbr.
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 population, and use is contraindicated for children in this age group.

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 potential adverse effects or changes in efficacy, 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 health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of the product. These include allergic reactions such as rash, pruritus, and urticaria. Other reported events encompass dizziness, nausea, vomiting, somnolence, confusion, and hallucinations. Additionally, cases of agitation and respiratory depression have been documented. There have also been reports of serotonin syndrome, particularly in patients who are concurrently using serotonergic medications.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to be aware that they should discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should be instructed to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

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 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being one extended-release tablet every 12 hours, not exceeding two tablets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin and Dextromethorphan Hbr, 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 Guaifenesin and Dextromethorphan Hbr, 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.

Learn more in our Editorial Policy

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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.