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Guaifenesin/Dextromethorphan hydrobromide

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This product has been discontinued

Active ingredients
  • Guaifenesin 1200 mg
  • Dextromethorphan Hydrobromide 60 mg
Other brand names
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 2017
Label revision date
November 3, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 1200 mg
  • Dextromethorphan Hydrobromide 60 mg
Other brand names
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 2017
Label revision date
November 3, 2018
Manufacturer
walgreens
Registration number
NDA021620
NDC root
0363-0076
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Mucus Relief DM is a medication that combines two active ingredients: guaifenesin (1200 mg) and dextromethorphan HBr (60 mg). It comes in the form of extended-release tablets and is designed to help relieve mucus and suppress coughs. Guaifenesin works by loosening phlegm and thinning bronchial secretions, making it easier to clear mucus from your airways. Dextromethorphan helps reduce the urge to cough, which can be particularly helpful for getting a good night's sleep.

This medication is indicated for temporary relief of cough caused by minor throat and bronchial irritation, such as that which may occur with the common cold or from inhaled irritants. Mucus Relief DM is formulated to provide both immediate and extended relief, making it a convenient option for managing symptoms associated with respiratory discomfort.

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 coughing 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 tablet whole—do not crush, chew, or break it. Make sure to take it with a full glass of water, which helps the tablet dissolve properly. You can take this medication at any time, regardless of your meal schedule.

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

What to Avoid

You should avoid using this product if you are a child under 12 years of age. Additionally, do not take it 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. It's also important to wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist for guidance.

Side Effects

If you experience a cough that 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 symptoms could indicate a serious illness.

Before using this medication, you should also speak with your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing excessive mucus (phlegm).

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 other 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.

Before using this product, it's important to talk to your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing a lot of mucus. If you experience an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also 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 condition.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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 12 years or older, the typical dosage is one tablet every 12 hours, but do not exceed two tablets in a 24-hour period. Always keep this medication 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. Your child's safety is a top priority, so please follow these guidelines carefully.

Geriatric Use

As you age, your body may respond differently to medications, including dextromethorphan and guaifenesin. Older adults often have increased sensitivity to the side effects of these ingredients, which means you might experience more pronounced effects than younger individuals. Additionally, if you have reduced kidney function (which is common in older adults), your doctor may need to adjust your dosage to ensure safety and effectiveness.

It's important to have regular check-ins with your healthcare provider while using this product. Monitoring for any adverse effects is crucial, as it helps ensure that you are using the medication safely and effectively. Always communicate any concerns or unusual symptoms to your doctor.

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 should be used if you have renal impairment (kidney issues).

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

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 (issues with liver function).

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 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, 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 your treatment options effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the carton is sealed and the blister pack's printed seal is intact before use. If either is broken or missing, do not use the product.

For proper storage, keep the product in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older advised to take 1 tablet every 12 hours, not exceeding 2 tablets in a 24-hour period. If you are under 12 years old, do not use this medication.

When taking the tablet, remember not to crush, chew, or break it. It's best to take it with a full glass of water, and you can take it at any time, regardless of meals.

FAQ

What is Mucus Relief DM?

Mucus Relief DM is a medication that contains GUAIFENESIN 1200 mg and DEXTROMETHORPHAN HBr 60 mg, formulated as extended-release tablets for mucus relief and cough suppression.

How does Mucus Relief DM work?

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

What are the dosage instructions for Mucus Relief DM?

Adults and children 12 years and older should take 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours. It is not recommended for children under 12 years of age.

Are there any contraindications for using Mucus Relief DM?

Do not use Mucus Relief DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or if you are under 12 years of age.

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

Stop using Mucus Relief DM and consult a doctor if your cough lasts more than 7 days, returns, or occurs with fever, rash, or persistent headache.

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

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

How should I take Mucus Relief DM?

Take Mucus Relief DM with a full glass of water and do not crush, chew, or break the tablet. It can be taken without regard for meals.

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.

Packaging Info

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

Packaging configurations for Guaifenesin and Dextromethorphan Hydrobromide.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Guaifenesin 1200 mg and Dextromethorphan HBr 60 mg are combined in an extended-release tablet formulation designed for the management of cough and mucus associated with respiratory conditions. Each tablet provides a maximum strength dosage that offers both immediate and extended release of the active ingredients, ensuring effective cough control and the thinning and loosening of mucus over a 12-hour period. The product is supplied in a package containing 28 extended-release tablets, each of actual size for accurate dosing.

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 expulsion of bothersome mucus and enhancing the productivity of coughs.

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

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

Dosage and Administration

Patients should take the tablet whole, without crushing, chewing, or breaking it. It is recommended to administer the tablet with a full glass of water. This medication can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. The use of this product is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

  • Children under 12 years of age.

  • Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past 2 weeks. Due to the potential for serious interactions, it is advised to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to use if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare professional.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients should 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 may indicate a serious underlying condition.

Before using this product, patients are advised to seek medical advice if they have a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider 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 disorders, emotional conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Guaifenesin and Dextromethorphan Hydrobromide.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of dextromethorphan and guaifenesin. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy.

Healthcare providers are advised to monitor elderly patients closely for any adverse effects when administering this product. This vigilance is particularly important given the heightened risk of side effects in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 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 drug insert 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 absence of detailed guidance 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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

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 provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Patients should be advised to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a more serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, it is advisable for patients to seek medical advice before using this medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals should ensure that the carton is not used if it is open or if the printed seal on the blister is broken or missing.

For optimal storage conditions, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours for adults and children aged 12 years and older, not exceeding two tablets within a 24-hour period. It is contraindicated for children under 12 years of age. Clinicians should advise patients not to crush, chew, or break the tablet and to take it with a full glass of water. The product can be taken without regard to meal timing.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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