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Mucus Relief Dm

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Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
June 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet
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 2025
Label revision date
June 1, 2025
Manufacturer
Bi-Mart
Registration number
M012
NDC root
37835-403
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes, which can happen with the common cold. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to clear out bothersome mucus from your airways. By doing so, it helps make your coughs more productive, allowing for better breathing and comfort.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a common cold, this medication can provide temporary relief. It works by soothing your throat and reducing the urge to cough.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions. This action makes it easier for your body to clear out bothersome mucus from your airways, ultimately making your coughs more productive. By clearing out mucus, you can breathe more comfortably and feel better overall.

Dosage and Administration

When you take this medication, make sure to swallow it with a full glass of water. If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed for relief. However, if you are caring for a child under 12 years of age, it’s important to note that this medication should not be used for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to follow the instructions provided with your medication carefully. You should not take more than the directed amount, as exceeding this can lead to unwanted effects. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use your medication responsibly to ensure your safety and well-being. If you have any questions or concerns about your medication, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication used for depression or certain other conditions—or have stopped taking one within the last two weeks, you should not use this product.

If you experience symptoms like fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these could indicate a more serious issue. Additionally, if your cough lasts more than a week or keeps coming back, you should seek medical advice. It's also advisable to talk to your doctor before using this medication if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with a lot of mucus.

Warnings and Precautions

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

In case of an overdose, it is crucial to seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also stop taking this medication and call your doctor if you experience symptoms such as fever, rash, or a persistent headache. Furthermore, if your cough lasts more than a week or keeps coming back, these could be signs of a more serious issue, and you should reach out to your healthcare provider.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the specific signs of overdose are not detailed, common symptoms may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide healthcare professionals with as much information as possible about the medication taken and the amount. Remember, acting quickly can make a significant difference in your safety and health.

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 be cautious when considering medication for children. If your child is under 12 years old, you should not use this medication. For those aged 12 and older, the recommended dosage is one tablet every four hours as needed. Always ensure that medications are kept out of reach of younger children to prevent accidental ingestion.

In the event of an overdose, it's crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Keeping these guidelines in mind will help ensure the safety and well-being of 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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson’s disease, you should not use 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, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially 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 in a cool, dry place at a temperature between 15° and 30°C (59° to 86°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

No further information is available.

FAQ

What does this drug do?

This drug temporarily relieves cough due to minor throat and bronchial irritation, helps loosen phlegm (mucus), and makes coughs more productive.

How should I take this drug?

Take 1 tablet every 4 hours as needed with a full glass of water. Do not use if you are under 12 years of age.

Are there any warnings I should be aware of?

Do not use this drug if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

When should I stop using this drug?

Stop use and ask a doctor if symptoms are accompanied by fever, rash, or persistent headache, or if the cough persists for more than one week.

What should I do in case of overdose?

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

Is it safe to use this drug during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if I have a chronic cough?

Ask a doctor before use if you have a persistent or chronic cough, such as from smoking, asthma, chronic bronchitis, or emphysema.

Packaging Info

Below are the non-prescription pack sizes of Mucus Relief Dm (guaifenesin, dextromethorphan hbr). 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

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur with the common cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication helps to make coughs more productive.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed. It is important not to exceed the recommended dosage.

This medication is not indicated for use in children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised not to exceed the recommended dosage.

Warnings and Precautions

Patients should not 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, the product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

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

Patients should discontinue use and consult a healthcare provider if any of the following symptoms occur: fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it is essential to seek medical advice, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in patients taking MAOIs or within two weeks of stopping 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 symptoms that warrant immediate medical attention. Patients should discontinue use and seek medical advice if symptoms are accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if a cough persists for more than one week or tends to recur, it is recommended that patients consult a healthcare provider, as this could also signify a serious health issue.

Before using this product, patients should inform their healthcare provider if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, a cough accompanied by excessive phlegm (mucus) should also prompt a discussion with a healthcare professional prior to use.

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, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a period 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, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Mucus Relief Dm.
Details

Pediatric Use

Children under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed. It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this demographic.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 they experience symptoms such as fever, rash, or a persistent headache.

Patients should also be informed to stop using the product and seek medical advice if their cough persists for more than one week or tends to recur, as these may indicate a more serious underlying condition. When using this product, patients must be cautioned not to exceed the recommended dosage.

Additionally, healthcare providers should encourage patients to consult 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. Patients should also be advised to seek medical guidance 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 is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

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.

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.