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Mucus Extended Release

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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 2025
Label revision date
June 17, 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 2025
Label revision date
June 17, 2025
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Registration number
ANDA078912
NDC root
51316-400
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Guaifenesin Extended-Release Tablets (1200 mg) are a maximum strength expectorant designed to help you manage chest congestion. This medication works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier to clear mucus from your airways and allowing for more productive coughs.

With a unique extended-release formula, these tablets provide relief for up to 12 hours, helping to alleviate discomfort caused by excess mucus. If you're dealing with chest congestion, Guaifenesin can be an effective option to help you breathe easier.

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.

In addition to easing the discomfort of chest congestion, this medication offers both immediate and extended-release options, ensuring you get relief when you need it most. Whether you're dealing with a cold or other respiratory issues, this treatment can help you feel more comfortable.

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, controlled substance classifications, or noted risks of abuse, misuse, or dependence (which means relying on a substance in a harmful way). 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. 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, you should 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 old. Before taking it, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing a lot of mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and contact your doctor, as these may indicate a more serious condition. In the event of an overdose, seek emergency medical help immediately or call the Poison Control Center 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 is important to know that this medication is not recommended for children under 12 years of age. If you have a child in this age group, you should avoid using this medication and consult with your healthcare provider for alternative options. Always prioritize your child's safety and well-being when considering any treatment.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 may affect you 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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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 based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

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 clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Guaifenesin Extended-Release Tablets used for?

Guaifenesin Extended-Release Tablets are used as an expectorant to help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

How should I take Guaifenesin Extended-Release Tablets?

You should take 1 extended-release tablet every 12 hours with a full glass of water. Do not exceed 2 tablets in 24 hours, and do not crush, chew, or break the tablet.

Who should not use Guaifenesin Extended-Release Tablets?

Do not use this product for 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, stop use and ask a doctor, as these could be signs of a serious illness.

Are there any specific warnings for using Guaifenesin Extended-Release Tablets?

Yes, you should ask a doctor before use if you have a persistent or chronic cough, such as from 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, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 using Guaifenesin Extended-Release Tablets.

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

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

Packaging Info

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

Packaging configurations for Mucus Extended Release.
Details

Drug Information (PDF)

This file contains official product information for Mucus Extended Release, 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 indicated for the relief of chest congestion. This formulation is designed to thin and loosen mucus, facilitating easier expectoration. The tablets provide both immediate and extended-release of the active ingredient, ensuring prolonged therapeutic effects.

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 and making coughs more productive.

The formulation is available in both immediate and extended-release forms, allowing for flexible dosing options to meet patient needs.

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.

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. This medication can be administered without regard to the timing of meals.

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 must 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 the use of this medication. It is contraindicated for 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 the cough is accompanied by excessive phlegm (mucus).

Patients should 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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Extended Release (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucus 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 therefore, its use is contraindicated in children within this age range.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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 potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

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 are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

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 should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Mucus 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 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.