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Mucus Relief Extended Release

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Active ingredient
Guaifenesin 1200 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 2019
Label revision date
February 10, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 1200 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 2019
Label revision date
February 10, 2026
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Registration number
ANDA207342
NDC root
70000-0479
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Guaifenesin is an active ingredient found in extended-release tablets designed to provide mucus relief. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear your airways. This can lead to more productive coughs and relief from chest congestion, allowing you to breathe more comfortably.

This maximum strength formulation is comparable to Mucinex® Maximum Strength, but it is distributed by Cardinal Health. If you're dealing with bothersome mucus, Guaifenesin may be a helpful option to consider for easing your symptoms.

Uses

If you're dealing with a cough and chest congestion, this medication can be quite helpful. It works by loosening phlegm (mucus) and thinning bronchial secretions, which makes it easier for you to clear out bothersome mucus from your airways.

By relieving chest congestion, this medication can help you breathe more comfortably. Overall, it aids in making your coughs more productive, allowing you to expel mucus more effectively.

Dosage and Administration

When taking this medication, it's important to swallow the tablet whole—do not crush, chew, or break it. Make sure to take it with a full glass of water, which helps the tablet dissolve properly in your stomach. You can take this medication at any time, regardless of your meal schedule.

For adults and children aged 12 years and older, the recommended dosage is one tablet every 12 hours. However, be careful not to exceed two tablets in a 24-hour period. If you have children under 12 years of age, this medication is not suitable for them, so please avoid using it for that age group.

What to Avoid

It's important to be aware of specific guidelines when considering this medication. You should not use it for children under 12 years of age, as it may not be safe for them.

Currently, there are no specified contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence (a condition where the body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. If you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus, it's important to consult a doctor before using this product.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and seek medical advice, as these symptoms may indicate a more serious condition. Additionally, if you are pregnant or breastfeeding, please consult a healthcare professional before use. Always keep this medication out of reach of children, and in case of an overdose, contact medical help or a Poison Control Center immediately at 1-800-222-1222.

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 due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus.

If your cough lasts more than 7 days, returns, or occurs with a fever, rash, or persistent headache, stop taking the medication and contact your doctor, as these may be signs of a more serious condition. In the event of an overdose, seek emergency medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Acting quickly can make a significant difference, so don’t hesitate to reach out for assistance if you notice any concerning symptoms. Your health and safety are 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.

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 meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns regarding the use of this medication for your child.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with regulations.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. If you are caring for a child under 12 years old, do not use this medication for them.

FAQ

What is Guaifenesin used for?

Guaifenesin is used for mucus relief, helping to loosen phlegm and thin bronchial secretions.

How does Guaifenesin work?

It helps loosen phlegm and thin bronchial secretions, making coughs more productive and relieving chest congestion.

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

The recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in 24 hours.

Can children under 12 use Guaifenesin?

No, Guaifenesin should not be used for children under 12 years of age.

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

You should stop using Guaifenesin and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Guaifenesin.

How should I take Guaifenesin?

You should take Guaifenesin with a full glass of water and do not crush, chew, or break the tablet.

What should I do in case of an overdose?

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

Where can I find more information about Guaifenesin?

You can find more information on the website www.myleader.com.

Packaging Info

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

Packaging configurations for Mucus Relief Extended Release.
Details

Drug Information (PDF)

This file contains official product information for Mucus Relief Extended Release, 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 relief of chest congestion associated with excessive mucus production. It helps to loosen phlegm and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. By enhancing mucus clearance, this medication makes coughs more productive, thereby alleviating symptoms of congestion.

Limitations of Use: This drug is intended for use in patients experiencing symptoms related to bronchial congestion and is not indicated for other respiratory conditions not associated with mucus production.

Dosage and Administration

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended to administer the tablet with a full glass of water. This product can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours. The maximum allowable dosage is 2 tablets within a 24-hour period.

This product is not indicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age.

Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

Patients are instructed to discontinue use and contact their healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is contraindicated for children under 12 years of age. Prior to use, patients should consult a healthcare professional if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Patients are advised to discontinue use and seek medical advice 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. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional before using this medication.

It is crucial to keep this medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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 Extended Release (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus Relief Extended Release.
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 population, and use is contraindicated for children in this age group.

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 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

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 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.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose 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, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there is no available information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 important to inform patients that this medication is not recommended for use in children under 12 years of age.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to using this medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice 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 controlled temperature range of 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets in a 24-hour period. It is contraindicated for use in 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 Mucus Relief Extended Release, 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 Extended Release, 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.