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Dextromethorphan hydrobromide/Guaifenesin

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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 2022
Label revision date
June 7, 2022
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 2022
Label revision date
June 7, 2022
Manufacturer
TopCo Associates, LLC
Registration number
M012
NDC root
76162-008
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

Mucus Relief DM is a medication designed to help you manage coughs and mucus buildup in your airways. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier to clear out bothersome mucus from your bronchial passageways. This can lead to more productive coughs, which means you can expel mucus more effectively.

In addition to helping with mucus, Mucus Relief DM temporarily relieves cough caused by minor throat and bronchial irritation, such as that which may occur with the common cold or from inhaling irritants. It also reduces the intensity of coughing and decreases the urge to cough, which can help you get a better night's sleep.

Uses

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

You can also 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 helps reduce the intensity of your cough and can even lessen the urge to cough, making it easier for you to get a good night's sleep.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed while your symptoms continue. It’s important to drink a full glass of water with each tablet to help it work effectively. However, make sure not to take more than 6 doses in a 24-hour period to avoid any potential side effects.

For children under 12 years of age, this medication is not recommended, so please do not use it for younger children. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

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

It's also important to follow the dosage instructions carefully and not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). 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. Do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you experience a cough that lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these could indicate a more serious health issue.

Before using this product, consult your doctor if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing excessive mucus. Additionally, if you are taking sedatives or tranquilizers, it's important to speak with a healthcare professional first. In the event of an accidental overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not use this product 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 accompanied by excessive mucus. Additionally, if you are taking sedatives or tranquilizers, check with your doctor or pharmacist first.

If you accidentally take too much of this product, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also stop using the product 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 accidental 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with a healthcare professional before using any medication. This ensures that you understand any potential effects on your milk production or your nursing infant. Always prioritize your health and your baby's well-being by seeking expert advice.

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 medications 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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and ensure that the treatment is safe and appropriate based on individual health needs.

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's crucial to be aware of potential interactions with other medications when considering this product. You should not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or certain emotional conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist.

Additionally, if you are taking sedatives or tranquilizers, it's important to speak with your healthcare provider before using this product. Discussing all your medications and any lab tests with your healthcare provider helps ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at a temperature between 20°-25°C (68°-77°F). It's important to keep it away from heat sources to maintain its effectiveness.

When handling the product, always check that the safety seal under the cap is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety 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 and older advised to take 1 tablet every 4 hours as needed, accompanied by a full glass of water. It's important not to exceed 6 doses within a 24-hour period. If the patient is under 12 years of age, this medication should not be used.

FAQ

What is Mucus Relief DM used for?

Mucus Relief DM helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving cough due to minor throat and bronchial irritation.

How should I take Mucus Relief DM?

Adults and children 12 years of age and older should take 1 tablet every 4 hours with a full glass of water while symptoms persist, not exceeding 6 doses in 24 hours.

Can children under 12 use Mucus Relief DM?

No, Mucus Relief DM should not be used in children under 12 years of age.

What should I do if I am taking a monoamine oxidase inhibitor (MAOI)?

Do not use Mucus Relief DM if you are currently taking an MAOI or have stopped taking one within the last 2 weeks. Consult a doctor or pharmacist if unsure.

What are the side effects of Mucus Relief DM?

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, stop use and consult a doctor, as these may indicate a serious illness.

What precautions should I take before using Mucus Relief DM?

Ask a doctor before use if you have a persistent cough, are taking sedatives or tranquilizers, or if your cough is accompanied by too much phlegm.

What should I do in case of an overdose?

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

How should I store Mucus Relief DM?

Store Mucus Relief DM between 20°-25°C (68°-77°F) in a dry place, and do not use if the safety seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Mucus Relief Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mucus Relief DM is a pharmaceutical formulation designed to alleviate symptoms associated with mucus production. It contains active ingredients that function as an expectorant and cough suppressant. The product is available in a liquid dosage form, facilitating ease of administration. The formulation is characterized by its specific molecular weight and chemical composition, which contribute to its therapeutic efficacy. The appearance of Mucus Relief DM is consistent with standard liquid medications, ensuring proper identification and use in clinical settings.

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 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 help patients achieve restful sleep.

Limitations of use include the absence of data regarding teratogenic or nonteratogenic effects; therefore, healthcare professionals should exercise caution when prescribing this medication to pregnant or breastfeeding patients.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours as needed while symptoms persist. It is essential not to exceed 6 doses within a 24-hour period.

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

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Furthermore, this product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing a cough that is accompanied by excessive phlegm (mucus) should also consult a healthcare professional before use. It is advisable for individuals taking sedatives or tranquilizers to discuss their medication regimen with a doctor or pharmacist prior to using this product.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven 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 this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or Parkinson’s disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication.

Patients are advised to stop using the product and consult a healthcare professional 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.

Additionally, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product. Coughs accompanied by excessive phlegm (mucus) also warrant consultation with a healthcare provider prior to use.

Patients taking sedatives or tranquilizers should ask a doctor or pharmacist for guidance before using this product. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while currently on an MAOI or within 2 weeks of discontinuing an MAOI. 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, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Additionally, caution is advised when considering the use of this product in conjunction with sedatives or tranquilizers. Patients should seek guidance from a healthcare provider before initiating use if they are currently taking these medications.

Packaging & NDC

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

Packaging configurations for Mucus Relief Dm.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this age group, and therefore, its use is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

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

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with its use during pregnancy.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. 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 accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate 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 accordingly.

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 arise during the course of treatment.

Nonclinical Toxicology

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

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-888-952-0050. This information contributes to the ongoing monitoring of the product's safety profile.

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 accidental overdose. It is important to emphasize that patients should not exceed the recommended dosage.

Patients should be encouraged to consult with their healthcare provider prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be informed to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Furthermore, healthcare providers should recommend that patients discuss their current medications with their doctor or pharmacist, especially if they are taking sedatives or tranquilizers, to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20°-25°C (68°-77°F) to maintain its integrity. It is essential to keep the product in a dry place, ensuring that it is not exposed to heat, which could compromise its quality. Additionally, the product must not be used if the imprinted safety seal under the cap is broken or missing, as this indicates potential tampering or contamination.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, with a full glass of water, not to exceed six doses within a 24-hour period. The use of this medication is not recommended for children under 12 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.