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Mucus Relief

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Active ingredient
Guaifenesin 1200 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Extended Release
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
May 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 1200 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Extended Release
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
May 23, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA217780
NDC root
51316-724
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

Guaifenesin is a medication that helps loosen phlegm (mucus) and thin bronchial secretions. By doing so, it aids in clearing the bronchial passageways of bothersome mucus, making coughs more productive. This can be particularly helpful when you're dealing with congestion from colds or respiratory infections, allowing you to breathe more easily.

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, making your coughs more productive. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

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

When taking this medication, it's important to swallow the extended-release tablet whole. Do not crush, chew, or break it, as this can affect how the medicine works. Make sure to take it with a full glass of water, and you can take it at any time, regardless of meals.

For adults and children aged 12 years and older, the recommended dose is one extended-release tablet every 12 hours. However, you should not take more than 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, risks of abuse or misuse, or concerns regarding dependence (which means relying on a substance to function normally). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these could indicate a more serious health issue.

Before using this medication, you should also speak with your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing excessive mucus.

Warnings and Precautions

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop taking this medication and call your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a more serious health issue that needs attention.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical help immediately.

Signs of an overdose can vary, but they may include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, or if you are unsure about your situation, do not hesitate to contact a healthcare professional or call emergency services for assistance. Your safety is the top priority, so it's always better to err on the side of caution.

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 about the appropriate 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 your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly and to determine if any changes to your medication are necessary.

For those with severe renal impairment, special considerations are required. Always consult your healthcare provider to discuss your specific situation and any necessary adjustments to your treatment plan. Your health and safety are the top priority, so staying informed and proactive is key.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and optimal results. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Guaifenesin used for?

Guaifenesin helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

How should I take Guaifenesin?

Take 1 extended-release tablet every 12 hours with a full glass of water. Do not exceed 2 tablets in 24 hours.

Can children use Guaifenesin?

Guaifenesin should not be used for children under 12 years of age.

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

Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Are there any warnings for using Guaifenesin?

Keep Guaifenesin out of reach of children and seek medical help in case of overdose.

What should I do if I am pregnant or breastfeeding?

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

How should I store Guaifenesin?

Store Guaifenesin at 20-25°C (68-77°F).

Are there any special considerations for patients with kidney or liver problems?

Patients with renal or hepatic impairment may require dosage adjustments and should have their function monitored.

Packaging Info

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin). 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

724R CVS Guaifenesin tablets are formulated to contain guaifenesin as the active ingredient. Guaifenesin is an expectorant used to relieve chest congestion by thinning mucus in the airways. The tablets are designed for oral administration and are presented in a standard tablet dosage form. The appearance of the tablets is consistent with typical pharmaceutical standards for this formulation.

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 clearance of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

The extended-release tablet should be taken with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken, as this may affect the release mechanism of the medication.

This product can be administered without regard for the timing of meals, allowing for flexibility in dosing. For adults and children aged 12 years and older, the recommended dosage is one extended-release tablet every 12 hours. The total daily dosage should not exceed two extended-release tablets within a 24-hour period.

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

Contraindications

Use is contraindicated in children under 12 years of age due to safety concerns associated with this population. No other contraindications have been specified.

Warnings and Precautions

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

It is imperative 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 should be contacted at 1-800-222-1222.

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

No specific laboratory tests are recommended for monitoring the use of this medication. However, vigilance in monitoring patient symptoms and responses to treatment is essential to ensure safety and efficacy.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a doctor if a cough lasts more than 7 days, returns, or occurs alongside fever, rash, or persistent headache, as these symptoms could indicate a serious underlying illness.

Additionally, patients should seek medical advice before using this medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Cough accompanied by excessive phlegm (mucus) is also a reason to consult a healthcare professional prior to use.

These precautions are essential to ensure the safe and effective use of the medication and to mitigate the risk of serious adverse reactions.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin). 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 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 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 health 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure appropriate management. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special considerations should be taken for patients with severe renal impairment to ensure their safety and the efficacy of treatment.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

It is essential to monitor patients closely for any signs of adverse reactions or symptoms that may arise from excessive dosing. In the event of suspected overdosage, immediate medical attention should be sought.

Healthcare providers should implement standard supportive measures, which may include symptomatic treatment and monitoring of vital signs. Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Documentation of the incident and any interventions undertaken is crucial for ongoing patient care and safety.

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

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 help immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that this medication is not recommended for use in children under 12 years of age. Patients should be counseled to stop using the medication and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Additionally, healthcare providers should encourage patients to consult a doctor before using the 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 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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.