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Mucosa Dm

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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 2017
Label revision date
October 27, 2023
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 2017
Label revision date
October 27, 2023
Manufacturer
Magno-Humphries, Inc.
Registration number
M012
NDC root
54257-277
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

This medication is designed to help you manage coughs associated with the common cold. It works by loosening phlegm (mucus) and thinning bronchial secretions, which makes your coughs more productive. By relieving minor throat and bronchial irritation, it can provide temporary relief when you're feeling under the weather.

If you're dealing with a cough due to a cold, this medication can help ease your symptoms and make it easier for you to clear mucus from your airways.

Uses

If you're dealing with a cough or congestion, this medication can be quite helpful. It works by loosening phlegm (a type of mucus) and thinning out bronchial secretions, which can make your coughs more productive. This means that when you do cough, it can help clear out the mucus more effectively.

Additionally, it provides temporary relief from coughing caused by minor irritation in your throat and bronchial tubes, especially when associated with the common cold. This can make you feel more comfortable as you recover.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take one tablet every four hours as long as your symptoms continue. Make sure to drink a full glass of water with each tablet. However, it’s important not to take more than six doses in a 24-hour period to avoid any potential risks.

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 ensure your safety when using this medication. You should not use it if the printed seal under the cap is missing or damaged, as this could indicate that the product is compromised.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these guidelines.

Side Effects

You should be aware of some important warnings and potential side effects associated with this medication. It is not recommended for children under 12 years old. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is used for certain mental health conditions, or if you have stopped taking one within the last two weeks, you should not use this medication. Additionally, consult your doctor if you have a cough with excessive mucus, or if you experience a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema.

If your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these may indicate a more serious issue. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is not suitable for children under 12 years old. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks, do not use this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before use.

Before using this product, talk to your doctor if you have a cough with excessive mucus, or if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema. Always follow the recommended dosage and do not use it for more than 7 days. If your cough lasts longer than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may indicate a more serious condition. If you are pregnant or breastfeeding, seek advice from a healthcare professional before using this product. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Don’t wait to see if symptoms improve; prompt action can be vital. Always prioritize your health and safety by reaching out for professional assistance in these situations.

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 is 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 be cautious when considering this medication for children. You should not use it for anyone under 12 years of age. Always follow the directions provided, which clearly state that this medication is not suitable for children in this age group. If you have any questions or concerns about its use, consult your healthcare provider for guidance.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the provided information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not detailed.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be cautious when taking Mucosa DM, especially if you are currently using a prescription medication called a monoamine oxidase inhibitor (MAOI) or if you have taken one in the past two weeks. MAOIs are a type of antidepressant that can interact negatively with Mucosa DM, potentially leading to serious side effects. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist before using Mucosa DM.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid harmful interactions. Your health is a priority, and your provider can help you make informed decisions about your treatment options.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). It's important to keep it in a dry place and avoid exposing it to excessive heat, as this can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. 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 one tablet every 4 hours as needed, but do not exceed 6 doses in a 24-hour period. If you are caring for a child under 12 years old, do not use this medication for them. Always take the tablet with a full glass of water to help it work effectively.

FAQ

What is the purpose of this medication?

This medication helps loosen phlegm (mucus), thins bronchial secretions, and temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold.

Who can take this medication?

Adults and children 12 years and older can take this medication. It is not recommended for children under 12 years of age.

What is the recommended dosage for adults and children 12 years and older?

You should take one tablet every 4 hours with a full glass of water while symptoms persist, but do not exceed 6 doses in 24 hours.

Are there any contraindications for this medication?

You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping an MAOI.

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

You should stop using the medication and ask a doctor if your cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Is it safe to use this medication if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this medication.

What should I do in case of an overdose?

In case of overdose, you should get medical help or contact a Poison Control Center right away.

How should I store this medication?

Store the medication at controlled room temperature between 15° to 30°C (59° to 86°F) and keep it in a dry place away from excessive heat.

Packaging Info

Below are the non-prescription pack sizes of Mucosa Dm (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucosa Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with the common cold. It helps loosen phlegm (mucus) and thins bronchial secretions, thereby making coughs more productive.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or cold symptoms.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take one tablet every 4 hours as needed while symptoms persist. It is essential 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 is contraindicated if the printed seal under the cap is missing or damaged. This precaution is necessary to ensure product integrity and safety.

Warnings and Precautions

The use of this product is contraindicated in children under the age of 12. Healthcare professionals should advise against its use in this population to prevent potential adverse effects.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks should not use this product. If there is uncertainty regarding the presence of MAOIs in a prescription medication, it is imperative to consult a healthcare provider or pharmacist prior to use.

Healthcare professionals should exercise caution and recommend that patients seek medical advice before using this product if they experience a cough accompanied by excessive phlegm (mucus), or if they have a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

It is essential to adhere to the recommended dosage guidelines when using this product. Patients should not exceed the advised dosage and should limit the duration of use to no more than 7 days.

If a cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, patients should discontinue use and consult a healthcare professional. These symptoms may indicate a more serious underlying condition that requires further evaluation.

For individuals who are pregnant or breastfeeding, it is crucial to seek guidance from a healthcare professional before using this product to ensure safety for both the mother and child.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay to receive appropriate care.

Side Effects

Patients should be aware of several important warnings and adverse reactions associated with the use of this medication. It is contraindicated in children under 12 years of age. Additionally, patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have stopped taking an MAOI within the last two weeks should not use this medication.

Patients with a cough that is accompanied by excessive phlegm, or those experiencing a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema should consult a healthcare professional before use. If a cough persists for more than 7 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 underlying condition.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. In the event of an overdose, immediate medical assistance should be sought, or patients should contact a Poison Control Center without delay.

Drug Interactions

The concomitant use of Mucosa DM with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients currently taking an MAOI or who have discontinued an MAOI within the past two weeks should not use Mucosa DM.

It is essential for patients to verify whether their prescription medications contain MAOIs. If there is any uncertainty regarding the presence of an MAOI in their medication regimen, patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment with Mucosa DM.

Packaging & NDC

Below are the non-prescription pack sizes of Mucosa Dm (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucosa Dm.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. There are no established safety or efficacy profiles for this age group, and specific dosing recommendations are not provided for children in this category. Caution is advised when considering treatment options for pediatric patients, and healthcare professionals should adhere to the age restrictions outlined in the prescribing information.

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. 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 the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, pruritus, and urticaria.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15° to 30°C (59° to 86°F). It is essential to keep the product in a dry place and to avoid exposure to excessive heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for ensuring the product's quality throughout its shelf life.

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 experience.

Drug Information (PDF)

This file contains official product information for Mucosa 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 Mucosa 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.