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Mucus Relief Dm

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Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
June 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2020
Label revision date
June 10, 2024
Manufacturer
The Kroger Co.
Registration number
M012
NDC root
30142-508
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

MUCINEX® FAST-MAX® DM MAX is a maximum strength, multi-symptom medication designed for individuals aged 12 and older. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant, and guaifenesin, an expectorant. This combination helps to temporarily relieve cough caused by minor throat and bronchial irritation, as well as chest congestion. Guaifenesin works by loosening phlegm (mucus) and thinning bronchial secretions, making coughs more productive and helping you breathe easier.

By controlling the impulse to cough, MUCINEX® FAST-MAX® DM MAX can also assist you in getting a better night's sleep. With a dosing schedule of every four hours, this medication is designed to provide effective relief from common cold symptoms and inhaled irritants.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions, making your coughs more productive. If you're dealing with a cough caused by minor throat and bronchial irritation, such as from a common cold or inhaled irritants, this medication can provide temporary relief.

Additionally, it can help reduce the intensity of your cough and lessen the urge to cough, which may help you get a better night's sleep.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure your safety and effectiveness. You should not take more than 6 doses within a 24-hour period. Always measure your dose using the dosing cup that comes with the product; using any other device could lead to incorrect dosing. Make sure to keep the dosing cup with the medication for easy access.

For adults and children aged 12 years and older, the recommended dose is 20 milliliters (mL) every 4 hours. If you have children under 12 years of age, do not use this medication for them. Always consult with your doctor if you have any questions or need further guidance on how to use this medication properly.

What to Avoid

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

It's also important to follow the recommended dosage carefully. Do not exceed the directed 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

It's important to be aware of certain warnings and precautions when using this product. You should not take it if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or other mental health 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, 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 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. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep this product out of reach of children, and in case of overdose, seek immediate medical help or contact a Poison Control Center.

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 persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus. Always follow the dosage instructions carefully and do not exceed the recommended amount. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may be signs of a more serious condition. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get 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 and any medications you may consider.

Pediatric Use

It's important to be cautious when considering this medication for children. If your child is under 12 years old, you should not use this medication. For those aged 12 and older, the recommended dosage is 20 mL every 4 hours. Always ensure that this medication is kept out of reach of 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 the top priority, so please follow these guidelines carefully.

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 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 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).

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 you understand how to manage your treatment effectively.

Drug Interactions

It's crucial to be aware of potential interactions when taking medications. 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, you should not take this product. Additionally, you need to wait at least two weeks after stopping an MAOI before using 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 harmful interactions. Your health is important, and your provider can help you make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 20-25°C (68-77°F). It's important not to refrigerate the product, as this could affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

No further information is available.

FAQ

What is MUCINEX® FAST-MAX® DM MAX used for?

MUCINEX® FAST-MAX® DM MAX is used to help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It temporarily relieves cough due to minor throat and bronchial irritation, the intensity of coughing, and the impulse to cough to help you sleep.

What are the active ingredients in MUCINEX® FAST-MAX® DM MAX?

The active ingredients are Dextromethorphan HBr (20 mg), a cough suppressant, and Guaifenesin (400 mg), an expectorant that helps thin and loosen mucus.

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

The recommended dosage for adults and children 12 years and older is 20 mL every 4 hours, not to exceed 6 doses in a 24-hour period.

Are there any warnings associated with MUCINEX® FAST-MAX® DM MAX?

Do not use this product 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 if your cough lasts more than 7 days.

Can I use MUCINEX® FAST-MAX® DM MAX if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using MUCINEX® FAST-MAX® DM MAX.

What should I do in case of an overdose?

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

Is MUCINEX® FAST-MAX® DM MAX safe for children?

MUCINEX® FAST-MAX® DM MAX is not recommended for children under 12 years of age.

How should I store MUCINEX® FAST-MAX® DM MAX?

Store MUCINEX® FAST-MAX® DM MAX between 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

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

Mucinex® Fast-Max® DM Max is a maximum strength formulation designed for individuals aged 12 and older, providing fast relief from multiple symptoms associated with respiratory conditions. This product contains Dextromethorphan HBr at a dosage of 20 mg, serving as a cough suppressant, and Guaifenesin at 400 mg, functioning as an expectorant. The combination effectively relieves chest congestion, controls cough, and thins and loosens mucus. The recommended dosing interval is every four hours.

This product is tamper evident; do not use if the printed safety seal under the cap is broken or missing. Mucinex® Fast-Max® DM Max is a registered trademark of Reckitt Benckiser, Slough, UK, which is not affiliated with The Kroger Co. or this product. Distributed by The Kroger Co., Cincinnati, Ohio 45202. For more information, visit www.kroger.com.

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 helps to loosen phlegm (mucus) and thin bronchial secretions, thereby making coughs more productive. Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, facilitating improved sleep.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product; the use of any other measuring device is not advised. It is essential to keep the dosing cup with the product at all times to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours as needed. For children under 12 years of age, the product is not indicated and should not be used. Healthcare professionals should advise patients to adhere strictly to these dosing guidelines or follow any specific instructions provided by a physician.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should consult a healthcare professional if uncertain whether their prescription includes an MAOI.

Additionally, exceeding the recommended dosage is contraindicated. Adherence to the directed dosage is essential to avoid potential adverse effects.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that is accompanied by excessive phlegm (mucus) should also consult a healthcare provider before use.

While using this product, it is crucial that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to discontinue use and consult a healthcare professional if their 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 evaluation.

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

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

While using this product, it is crucial that patients adhere strictly to the recommended dosage and do not exceed the directed amount.

Patients should 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.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a healthcare professional prior to use.

Additionally, this product should be kept 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.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Dm (dextromethorphan hydrobromide guaifenesin). 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. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 4 hours. 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 contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 not been specifically addressed in the drug insert text 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 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. 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 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 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 teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. It is important to emphasize that patients must adhere to the recommended dosage and not exceed the directed amount while using this product.

Additionally, healthcare providers should recommend that patients consult a doctor before using this product 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mucus Relief Dm, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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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.