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Mucus Relief

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
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 2024
Label revision date
December 26, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
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 2024
Label revision date
December 26, 2025
Manufacturer
Pioneer Life Sciences, LLC
Registration number
M012
NDC root
72090-009
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Mucus Relief is a medication designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it helps make your coughs more productive, allowing you to expel bothersome mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways.

Additionally, it makes your coughs more productive, meaning that when you do cough, it can help you expel mucus more effectively. This can be particularly helpful if you're dealing with congestion or respiratory issues.

Dosage and Administration

When you need to take this medication, adults and children aged 12 years and older should take 1 tablet every 4 hours as long as symptoms continue. It’s important to drink a full glass of water with each tablet. However, make sure not to take more than 6 tablets in a 24-hour period to avoid any potential issues.

Remember, you should not crush, chew, or break the tablet, as this can affect how the medication works. If you have children under 12 years old, this medication is not suitable for them, so please avoid using it for that age group. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to use this medication responsibly. You should never exceed the recommended dosage, as doing so can lead to serious health issues. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, it's always best to follow the guidelines provided by your healthcare professional to ensure your safety and well-being. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor or pharmacist for guidance.

Side Effects

You may experience some side effects while using this medication. One important warning to note is that it can cause a persistent cough, similar to what you might experience with smoking, asthma, chronic bronchitis, or emphysema. If your cough is accompanied by excessive phlegm (mucus), it's important to consult your healthcare provider.

Please be aware of these potential reactions and discuss any concerns with your doctor to ensure your safety and well-being.

Warnings and Precautions

It's important to keep this product out of reach of children. If you suspect an overdose, seek medical help right away or contact a Poison Control Center at 1-800-222-1222. Always follow the recommended dosage and do not exceed it.

Before using this product, consult your doctor if you have a persistent cough, especially if it’s related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough comes with excessive phlegm (mucus), stop using the product and call your doctor for further advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering medication for children. For children under 12 years old, this medication should not be used at all. If you have a child aged 12 or older, they can take 1 tablet every 4 hours as needed, but make sure they drink a full glass of water with it. They should not take more than 6 doses in a 24-hour period.

Always keep this medication out of reach of children. If you suspect an overdose, seek medical help right away or contact a Poison Control Center at 1-800-222-1222. Your child's safety is the top priority, so follow these guidelines closely.

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 your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests is essential to ensure your kidneys are managing medications effectively.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider taking a lower dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your healthcare provider might change how much of the medication you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your liver health while you are on this medication.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, who can guide you on the best approach to your treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F), allowing for brief periods between 15°-30°C (59°-86°F). It's important to keep the product in a dry location and avoid exposing it to 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 ensure that you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Mucus Relief used for?

Mucus Relief helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, making coughs more productive.

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

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

Can children under 12 years use Mucus Relief?

No, Mucus Relief should not be used by children under 12 years.

What should I do in case of an overdose?

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

Are there any warnings associated with Mucus Relief?

You should not exceed the recommended dosage and keep the medication out of reach of children.

What should I do if I have a persistent cough?

Ask a doctor before use if you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

Is it safe to use Mucus Relief during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a healthcare professional before use.

How should Mucus Relief be stored?

Store Mucus Relief at 25°C (77°F) with excursions between 15°-30°C (59°-86°F) in a dry place and avoid exposure to heat.

Packaging Info

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin 400 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication enhances the productivity of coughs, aiding in the effective expulsion of respiratory secretions.

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

Dosage and Administration

Adults and children 12 years and older are instructed to take 1 tablet every 4 hours as needed while symptoms persist. It is essential not to exceed 6 doses within a 24-hour period. The tablet should be taken with a full glass of water to ensure proper swallowing and absorption.

Healthcare professionals should advise patients against crushing, chewing, or breaking the tablet, as this may affect the medication's efficacy and safety.

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

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Warnings It is imperative to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

General Precautions Users must adhere strictly to the recommended dosage and should not exceed this amount to avoid potential adverse effects.

Emergency Medical Help In cases of overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay.

Consultation with Healthcare Provider Patients should be advised to consult a healthcare provider prior to use if they have a persistent cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, if the cough is accompanied by excessive phlegm (mucus), it is essential to stop taking the product and seek medical advice.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Among the notable warnings, persistent cough has been reported, particularly in individuals with a history of smoking, asthma, chronic bronchitis, or emphysema. This cough may be indicative of underlying respiratory conditions.

Additionally, if the cough is accompanied by excessive phlegm (mucus), it is important for patients to seek medical advice, as this may signify a more serious underlying issue that requires further evaluation. Monitoring for these symptoms is advised to ensure appropriate management and intervention if necessary.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin 400 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief.
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 1 tablet every 4 hours as needed, with a full glass of water, while symptoms persist. The maximum allowable dosage is 6 tablets within a 24-hour period.

It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Geriatric Use

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment may require dosage adjustments due to reduced renal function. It is essential to monitor renal function tests regularly in individuals with known kidney problems. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

Monitoring should continue until the patient is stable and any potential complications have been addressed. Documentation of the incident, including the substance involved, estimated dose, time of exposure, and interventions performed, is critical for ongoing care and future reference.

Healthcare professionals are encouraged to familiarize themselves with local protocols and guidelines regarding overdose management to ensure prompt and effective treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be cautioned not to exceed the recommended dosage, as doing so may lead to adverse effects. It is important for healthcare providers to encourage patients to consult with a doctor before using the medication if they have a persistent cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be informed that if their cough is accompanied by excessive phlegm (mucus), they should seek medical advice.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial 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).

To ensure the integrity of the product, it must be kept in a dry place, away from heat sources. Proper handling and storage conditions are vital to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Mucus Relief, 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, 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.