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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 2025
Label revision date
December 25, 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 2025
Label revision date
December 25, 2025
Manufacturer
Pioneer Life Sciences, LLC
Registration number
M012
NDC root
72090-044
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 Regular Strength is a medication designed to help you manage mucus in your airways. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to clear out bothersome mucus from your bronchial passageways. This can help make your coughs more productive, allowing you to breathe more comfortably.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a type of mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive. This can be particularly helpful if you're dealing with a cough that feels unproductive or if you're experiencing congestion.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as long as your symptoms continue. It's important to drink a full glass of water with each tablet to help it work effectively. However, make sure not to take more than 6 doses in a 24-hour period to avoid any potential side effects.

For children under 12 years old, 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

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

It's important to be aware of certain warnings and considerations when using this medication. You should not use it if you are under 12 years of age. Additionally, before using this medication, consult your doctor if you have a persistent cough, especially if it is related to smoking, asthma, chronic bronchitis, or emphysema. You should also seek medical advice if your cough is accompanied by excessive phlegm (mucus).

Taking these precautions can help ensure your safety and the effectiveness of the treatment.

Warnings and Precautions

You should not use this medication if you are under 12 years of age. Before using it, 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 is producing a lot of phlegm (mucus), it’s important to seek medical advice.

In the event of an overdose, you must get emergency medical help right away or contact a Poison Control Center at 1-800-222-1222. Always prioritize your health and safety by following these guidelines.

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 is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place 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 professional 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 is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child is at least 12 years old before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

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 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), but it can safely handle brief excursions between 15°-30°C (59°-86°F). It's important to keep the product in a dry place and avoid exposing it to heat, as this can affect its quality and 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 Regular Strength used for?

Mucus Relief Regular Strength helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing the bronchial passageways.

Who can take Mucus Relief Regular Strength?

Adults and children 12 years and older can take 1 tablet every 4 hours with a full glass of water while symptoms persist, but do not exceed 6 doses in 24 hours. It should not be used by children under 12 years.

Are there any warnings for using Mucus Relief Regular Strength?

Yes, do not use this medication for children under 12 years of age. Additionally, consult a doctor if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by too much phlegm.

What should I do in case of an overdose?

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

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

If you are pregnant or breastfeeding, you should ask a healthcare professional before using Mucus Relief Regular Strength.

How should I store Mucus Relief Regular Strength?

Store Mucus Relief Regular Strength at 25°C (77°F), keeping it in a dry place and avoiding 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 drug.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the removal of bothersome mucus from the bronchial passageways.

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 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

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not prescribed to this demographic to avoid potential adverse effects.

Patients should be advised to consult a physician 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), medical advice should be sought before administration.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare providers should instruct patients to contact a Poison Control Center at 1-800-222-1222 for guidance.

While specific instructions regarding discontinuation of the medication were not provided, healthcare professionals should remain vigilant and encourage patients to report any concerning symptoms or adverse reactions that may arise during treatment.

Side Effects

The use of this medication is contraindicated in children under 12 years of age. Patients should be advised to consult a healthcare professional prior to use if they have a persistent cough, particularly one associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

These precautions are essential to ensure the safe and effective use of the medication, minimizing the risk of adverse reactions in vulnerable populations and those with specific respiratory conditions.

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 be administered this medication. Safety and efficacy have not been established in this age group, and use is contraindicated. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children under 12 years.

Geriatric Use

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

Pregnancy

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the relevant authorities to contribute to the ongoing assessment of the medication's safety profile.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and 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. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action.

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 of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

It is essential to keep the product in a dry place and to avoid exposure to heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product remains within the specified temperature range.

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

Last AI update:

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.