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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
May 1, 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
May 1, 2025
Manufacturer
Bi-Mart
Registration number
M012
NDC root
37835-401
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

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it can help make your coughs more productive, allowing you to breathe more comfortably. If you're dealing with congestion or a cough, this drug may assist in alleviating those symptoms by promoting better mucus clearance from your bronchial passageways.

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 a cough that feels unproductive or if you're experiencing congestion.

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. You can take this medication at any time, regardless of your meal schedule.

For adults and children aged 12 years and older, the recommended dose is one tablet every four hours. However, you should not take more than six tablets in a 24-hour period. If you are caring for a child under 12 years old, please do not use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. If you have a persistent or chronic cough—like those caused by 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.

Additionally, you should stop using the medication and seek medical advice if your cough lasts more than 7 days, returns, or occurs with symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Warnings and Precautions

You should not use this medication if you are under 12 years old. If you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus, please consult your doctor before using this product. It's important to stop using it and contact your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious condition.

If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this medication. In the event of an overdose, seek emergency medical help immediately or contact a 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 overdoses 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 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

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes to your medications.

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 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 new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety. Always check the printed seal under the cap before use; if it is missing or damaged, do not use the product, as this could compromise its safety and effectiveness.

When handling the product, make sure to do so in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing the bronchial passageway.

How should I take this medication?

You should take the tablet with a full glass of water and not crush, chew, or break it. It can be taken without regard for meal timing.

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

Adults and children 12 years of age and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

Is this medication safe for children under 12?

No, this medication 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 the medication 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, you should ask a health professional before using this medication.

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.

Are there any specific warnings for this medication?

Yes, do not use this medication for children under 12 years of age and consult a doctor if you have a persistent cough or cough with excessive phlegm.

How should I store this medication?

Store the medication at 20-25°C (68-77°F) and do not use it if the printed seal under the cap is missing or damaged.

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

The product is identified by the SPL code 34089-3. No specific description details are provided in the available information.

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 passageway. By enhancing mucociliary clearance, this medication aims to make coughs more productive, thereby alleviating symptoms associated with respiratory congestion.

Dosage and Administration

Patients should take the tablet whole, without crushing, chewing, or breaking it. It is recommended to ingest the tablet with a full glass of water. This medication can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours. The total daily dosage should not exceed 6 tablets within a 24-hour period.

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

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 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 are instructed to discontinue use and consult a healthcare provider 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.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional before using this medication to ensure safety for both the mother and child.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

No specific laboratory tests are required for monitoring during the use of this medication. However, healthcare providers should remain vigilant for any adverse effects or complications that may arise during treatment.

Side Effects

Patients should be aware of the following warnings and recommendations regarding 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 associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before using this product.

Patients are advised to discontinue use and consult a healthcare provider if their 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 medical evaluation.

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. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 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 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 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

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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 essential 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 a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it must not be used if the printed seal under the cap is missing or damaged, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are essential to ensure the quality of the product throughout its shelf life.

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.