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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
October 21, 2021
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
October 21, 2021
Manufacturer
Rite-Aid
Registration number
NDA021620
NDC roots
11822-7156, 11822-8157
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Drug Overview

MUCUS RELIEF DM is a maximum strength medication designed to help you manage cough and mucus associated with common colds or inhaled irritants. It contains two active ingredients: guaifenesin (1200 mg), which acts as an expectorant to help loosen and thin mucus in your airways, making it easier to cough up, and dextromethorphan HBr (60 mg), a cough suppressant that reduces the urge to cough, allowing you to rest better.

This medication comes in extended-release tablets, providing both immediate and prolonged relief. By thinning and loosening mucus, MUCUS RELIEF DM helps make your coughs more productive while temporarily relieving throat and bronchial irritation.

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 in your stomach. 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, please do not use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product if you are 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 or certain psychiatric conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication includes an MAOI, please consult your doctor or pharmacist before using this product.

It's also important to follow the dosage instructions carefully. Do not exceed the recommended amount when using this product, as misuse can lead to serious health issues. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. It is not recommended for children under 12 years old, and you should avoid using it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks. If you're unsure whether your medication contains an MAOI, consult your doctor or pharmacist.

Before using this product, talk to your doctor if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus. You should stop using the medication and seek medical advice if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious condition.

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 persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive 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 occurs with 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

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. For those who are 12 years and older, the typical dosage is one tablet every 12 hours, with a maximum of two tablets in a 24-hour period. Always follow these guidelines to 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment.

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 and well-being are the top priority, so don't hesitate to ask questions about your treatments.

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 as follows: Adults and children aged 12 years and older can take 1 tablet every 12 hours, but do not exceed 2 tablets in a 24-hour period. If your child is under 12 years old, do not use this medication.

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication. 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 maximum strength medication that contains GUAIFENESIN 1200 mg and DEXTROMETHORPHAN HBr 60 mg in extended-release tablets, acting as an expectorant and cough suppressant.

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 minor throat and bronchial irritation.

Who should use MUCUS RELIEF DM?

Adults and children 12 years and older can use it, taking 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours. It should not be used by children under 12 years of age.

Are there any contraindications for MUCUS RELIEF DM?

Yes, do not use it 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?

You should stop using MUCUS RELIEF DM and consult a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

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.

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.

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.

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. This product functions as both an expectorant and a cough suppressant, effectively controlling cough while thinning and loosening mucus. The formulation provides both immediate and extended release of active ingredients, ensuring therapeutic effects for up to 12 hours. Each package contains 14 extended-release tablets.

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 assists 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 aid in promoting sleep.

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

Dosage and Administration

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended that the tablet be ingested with a full glass of water. This medication can be administered 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. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use of this product.

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 are advised 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 be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, and it is crucial to adhere to the following warnings and recommendations.

This product is contraindicated for use in children under 12 years of age. Additionally, it should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients must refrain from using this product for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to consult a healthcare professional.

Patients should seek medical advice before using this product if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals with a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider prior to use.

Patients are instructed to discontinue use and consult a doctor if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical attention.

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 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 verify 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. Caution is advised when administering this medication to ensure adherence to the specified dosing guidelines.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Patients and healthcare professionals are encouraged to report any adverse events associated with the use of the product 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 stopped taking an MAOI within the last 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, healthcare providers should recommend that patients 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 are advised not to use the product if the carton is open or if the printed seal on the blister is broken or missing.

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

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. The use of this medication is not recommended for children under 12 years of age. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center can be contacted at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.