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Mucinex Cough Chest Congestion

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Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
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
December 23, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Capsule, Liquid Filled
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
December 23, 2024
Manufacturer
RB Health (US) LLC
Registration number
M012
NDC root
72854-137
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® is a medication designed to help relieve cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to reduce the urge to cough, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination makes it easier for you to clear mucus from your airways, allowing for more productive coughing and relief from irritation caused by the common cold or other inhaled irritants.

By thinning and loosening mucus, Mucinex® can help you breathe more easily and get a better night's sleep by reducing the intensity of your cough. It is suitable for individuals aged 12 and older who are experiencing these symptoms.

Uses

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

You can use this medication to temporarily relieve coughing caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It also helps reduce the intensity of your cough and can lessen the urge to cough, making it easier for you to get a good night's sleep.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. If you are an adult or a child aged 12 years and older, you should take 2 liquid gels every 4 hours as needed. However, make sure not to exceed 12 liquid gels in a 24-hour period.

If you have a child under 12 years of age, this medication is not suitable for them, and you should avoid using it for that age group. Always remember to read the instructions carefully and consult with a healthcare professional if you have any questions or concerns about using this medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when considering this medication. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are certain medications used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for guidance.

Warnings and Precautions

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, certain psychiatric conditions, or Parkinson’s disease. Additionally, you must wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always prioritize your safety. If you experience any unusual symptoms or side effects while using this medication, stop taking it immediately and contact your doctor for guidance. Your health is paramount, and it's essential to stay informed about the medications you are using.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of Mucinex® Cough & Chest Congestion during pregnancy has not been established. There may be potential risks to your fetus, but specific studies or data are not available to clarify these risks. Therefore, it is crucial to consult with your healthcare provider before using this product.

While there are no specific dosage modifications mentioned for pregnant individuals, caution is advised. Always discuss any medications you are considering with your healthcare professional to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can use Mucinex® Cough & Chest Congestion without specific warnings or recommendations against it. Currently, there is no information available about whether the ingredients in this medication pass into breast milk or if they pose any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. For those who are 12 years and older, the dosage is two liquid gels every four hours as needed. Always ensure you follow these guidelines to keep your child safe and healthy.

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

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, 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 a temperature between 20-25°C (68-77°F). It's important to keep it away from excessive heat, as this can affect its quality and effectiveness.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure that you use the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Mucinex®?

Mucinex® is a fast dissolving liquid gel that contains dextromethorphan HBr, a cough suppressant, and guaifenesin, an expectorant.

What does Mucinex® do?

Mucinex® helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough due to minor throat and bronchial irritation.

Who can use Mucinex®?

Mucinex® is intended for adults and children aged 12 years and over. Children under 12 years of age should not use it.

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

The recommended dosage is 2 liquid gels every 4 hours, with a maximum of 12 liquid gels in any 24-hour period.

Are there any warnings for using Mucinex®?

Do not use Mucinex® if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

Is Mucinex® safe to use during pregnancy?

The safety of Mucinex® during pregnancy has not been established, and it is recommended to consult a healthcare provider before use.

Can nursing mothers use Mucinex®?

There are no specific warnings or recommendations regarding the use of Mucinex® in nursing mothers.

How should Mucinex® be stored?

Store Mucinex® at 20-25°C (68-77°F) and avoid excessive heat.

Packaging Info

Below are the non-prescription pack sizes of Mucinex Cough Chest Congestion (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Cough Chest Congestion.
Details

Drug Information (PDF)

This file contains official product information for Mucinex Cough Chest Congestion, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mucinex® is a fast-dissolving liquid gel formulation indicated for the relief of cough and chest congestion. Each liquid-filled capsule contains dextromethorphan HBr, a cough suppressant, and guaifenesin, an expectorant that thins and loosens mucus, thereby relieving chest congestion and controlling cough. The product is designed for individuals aged 12 and older. The National Drug Code (NDC) for this formulation is 72854-137-16.

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, facilitating the clearance of bothersome mucus and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, thereby aiding in sleep.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 liquid gels every 4 hours as needed. The maximum allowable dosage is 12 liquid gels within a 24-hour period.

Use of this medication is not recommended for children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is imperative to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI.

Healthcare professionals are advised to ensure that patients are aware of the potential interactions with MAOIs. If there is any uncertainty regarding whether a prescribed medication contains an MAOI, patients should be instructed to consult with their healthcare provider or pharmacist prior to initiating treatment with this product.

Side Effects

Patients should be aware of the serious warnings associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, the product should not be used for a period of two weeks following the discontinuation of an MAOI. Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, if they are uncertain whether their prescription medication contains an MAOI.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or 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 includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Cough Chest Congestion (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Cough Chest Congestion.
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 2 liquid gels every 4 hours.

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

The safety of Mucinex® Cough & Chest Congestion during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

While no specific dosage modifications for pregnant individuals are mentioned, caution is advised when considering the use of this product. It is recommended that women of childbearing potential discuss the use of Mucinex® Cough & Chest Congestion with a healthcare professional to ensure informed decision-making regarding potential risks and benefits during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Mucinex® Cough & Chest Congestion in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the drug in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, which may compromise the integrity of the product. Proper storage conditions are essential to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mucinex Cough Chest Congestion, 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 Mucinex Cough Chest Congestion, 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.