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Dextromethorphan hydrobromide/Guaifenesin

Last content change checked dailysee data sync status

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
May 18, 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
May 18, 2022
Manufacturer
Allegiant Health
Registration number
M012
NDC root
69168-432
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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 helps clear out bothersome mucus from your airways, making your coughs more productive.

You can also 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 can reduce the intensity of your cough and help 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 can take 1 tablet every 4 hours as needed while your symptoms last. 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

It's important to be cautious when considering this medication. You should not use it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed 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're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Taking this medication while on an MAOI can lead to serious health risks, so it's crucial to follow these guidelines to ensure your safety.

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 have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus, consult your doctor before using this product.

While using this medication, it’s crucial to follow the dosage instructions carefully. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and seek medical advice, as these may indicate a more serious condition. If you are pregnant or breastfeeding, please consult a healthcare professional before use. Always keep this medication out of reach of children, and in case of accidental overdose, contact a medical professional or Poison Control Center immediately.

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.

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.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and well-being.

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 should not be used in children under 12 years of age. For those who are 12 years and older, the recommended dosage is one tablet every four hours as needed, but you should not take more than six tablets in a 24-hour period. Always make sure to take the tablet with a full glass of water.

To keep your child safe, store this medication out of their reach. If you suspect an accidental overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when taking certain medications together. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your current medication includes an MAOI, please consult your doctor or pharmacist.

Before using this product, it's also wise to check with your healthcare provider if you are taking sedatives or tranquilizers, as these can interact with the medication. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally around 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F), but make sure to keep it in a dry place and away from heat sources.

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. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 hours with a full glass of water, but do not exceed 6 doses in a 24-hour period. If your child is under 12 years old, do not use this medication.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. In the event of an accidental overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, you can report any side effects you experience by calling 1-888-952-0050.

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.

Who can take Mucus Relief DM?

Adults and children 12 years and older can take Mucus Relief DM. It is not recommended for children under 12 years of age.

What is the recommended dosage for adults and children over 12?

The recommended dosage is 1 tablet every 4 hours with a full glass of water while symptoms persist, not exceeding 6 doses in 24 hours.

Are there any warnings associated with Mucus Relief DM?

Do not use Mucus Relief DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if you have a persistent cough or cough with excessive phlegm.

What should I do if I experience an overdose?

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

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

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

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.

How should I store Mucus Relief DM?

Store Mucus Relief DM at 25°C (77°F) with excursions between 15°-30°C (59°-86°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 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 relieves the intensity of coughing and the impulse to cough, which may assist patients in achieving restful sleep.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 12 years and older are advised to take 1 tablet every 4 hours as needed while symptoms persist. It is important to administer the tablet with a full glass of water. The maximum allowable dosage is 6 tablets 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. Due to the potential for serious interactions, patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

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 there is uncertainty regarding the presence of an MAOI in their prescription medications.

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 are advised 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 who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients should refrain from using it for at least two weeks after stopping an MAOI.

Common adverse reactions may include persistent or chronic cough, especially in patients with underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should consult a healthcare professional prior to use.

While using this product, it is crucial for patients to adhere strictly to the recommended dosage. If a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, patients are advised to discontinue use and seek medical attention, as these symptoms may indicate a serious illness.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this product to ensure safety for both the mother and child. Furthermore, this product should be kept out of reach of children, and in the event of an accidental overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on a prescription MAOI or for a period of two weeks following the discontinuation of an MAOI. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Patients uncertain about whether their prescription includes an MAOI 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

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 with a full glass of water, while symptoms persist. The maximum allowable dosage is 6 doses within a 24-hour period.

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

Geriatric Use

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. 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 on 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. 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 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 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

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that side effects may be reported voluntarily by healthcare professionals and patients. Reports can be submitted to the designated contact number, 1-888-952-0050. This information is collected through various surveillance programs to monitor the safety profile of the product.

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, 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 specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

The product must be kept in a dry place, ensuring that it is not exposed to heat or moisture, which could compromise its integrity. Additionally, it is critical to verify that the imprinted safety seal under the cap is intact; the product should not be used if this seal is broken or missing. Proper adherence to these storage and handling guidelines will help maintain the product's efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take one tablet orally every four hours with a full glass of water while symptoms persist, without exceeding six doses in a 24-hour period. The 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 before use. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222.

For reporting side effects, patients can reach out to 1-888-952-0050. No additional information is available regarding laboratory tests or abuse potential.

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.