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Mucus Relief

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Active ingredient
Guaifenesin 1200 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Multilayer, 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 2021
Label revision date
May 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 1200 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Multilayer, 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 2021
Label revision date
May 8, 2025
Manufacturer
Meijer Distribution Inc
Registration number
ANDA213420
NDC root
41250-654
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 Extended-Release Tablets are a maximum strength expectorant designed to help relieve chest congestion. Each tablet contains 1200 mg of guaifenesin, which works by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear the bronchial passageways of bothersome mucus, making coughs more productive and providing relief from congestion.

These tablets offer both immediate and extended release, allowing for up to 12 hours of relief. With 14 extended-release tablets in a package, Guaifenesin is a convenient option for those seeking to alleviate symptoms associated with respiratory conditions.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it clears out the bronchial passageways of bothersome mucus, 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 in your chest.

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 with absorption. 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, 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, controlled substance classifications, or noted risks of abuse, misuse, or dependence (which means relying on a substance in a way that can be harmful). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

You should avoid using this medication if you are under 12 years old. If you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces a lot of mucus, it's important to consult your doctor before using it.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these symptoms may indicate a more serious condition.

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 is accompanied by fever, rash, or a 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 or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

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

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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's important to know that this medication is not recommended for children under 12 years of age. If your child is 12 years or older, they can take 1 tablet every 12 hours, but make sure they do not exceed 2 tablets in a 24-hour period.

If your child has a cough that lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, these could be signs of a more serious illness, and you should consult a healthcare professional. Always prioritize your child's health and safety when considering medication.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment.

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 may not have known conflicts with other drugs or 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 in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is Guaifenesin Extended-Release Tablets used for?

Guaifenesin Extended-Release Tablets are used to relieve chest congestion by thinning and loosening mucus, making coughs more productive.

How should I take Guaifenesin Extended-Release Tablets?

You should take 1 tablet every 12 hours with a full glass of water, and do not exceed 2 tablets in 24 hours.

Who should not use Guaifenesin Extended-Release Tablets?

This product should not be used by children under 12 years of age.

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

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, you should stop use and ask a doctor.

Are there any specific warnings for using this medication?

Yes, you should ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by too much phlegm.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

Can I take Guaifenesin Extended-Release Tablets if I am pregnant or breastfeeding?

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

What is the storage condition for Guaifenesin Extended-Release Tablets?

Store the tablets between 20°-25°C (68°-77°F).

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

Guaifenesin Extended-Release Tablets contain 1200 mg of guaifenesin, an expectorant designed to relieve chest congestion by thinning and loosening mucus. This formulation provides both immediate and extended release of the active ingredient, ensuring therapeutic effects over a 12-hour period. Each package contains 14 extended-release tablets, suitable for sustained relief from symptoms associated with respiratory conditions.

Uses and Indications

This drug is indicated for the management of respiratory conditions characterized by excessive mucus production. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. By enhancing mucociliary function, this medication aims to make coughs more productive, thereby alleviating symptoms associated with respiratory congestion.

Limitations of Use: This drug is not intended for the treatment of conditions that do not involve mucus production or for patients who do not require assistance in clearing bronchial secretions.

Dosage and Administration

Patients should take the tablet with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken prior to administration. This product can be taken without regard for the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours. The total daily dosage should not exceed 2 tablets within a 24-hour period.

This product is not recommended for use in 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

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 those 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 should be 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 the potential adverse reactions associated with this medication. It is contraindicated for use in children under 12 years of age. Prior to use, patients are advised to 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 their cough is accompanied by excessive phlegm (mucus).

Patients are also instructed 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.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. 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 use this product, as specific dosing information is not provided and it is not recommended for this age group. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

Healthcare professionals should advise caregivers that if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires further evaluation.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

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 the individual’s health status. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific circumstances of the overdose.

Healthcare providers are encouraged to monitor the patient closely for any adverse effects and to initiate supportive care as necessary. This may include symptomatic treatment and stabilization of vital signs. It is essential to document the incident and any interventions performed for future reference and to inform ongoing patient care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are currently no additional adverse events or rare case reports to summarize.

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 fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is 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.

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.