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Mucus Relief

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Active ingredient
Guaifenesin 600 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 600 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
ANDA213420
NDC root
37835-408
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 you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in clearing 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.

Uses

If you're dealing with a cough that produces mucus, this medication can help. It works by loosening phlegm (a type of mucus) and thinning out bronchial secretions. This makes it easier for you to clear out the mucus from your airways, leading to more productive coughs. By helping to rid your bronchial passageway of bothersome mucus, it can provide relief and make breathing easier.

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 and older, the recommended dose is 1 or 2 tablets every 12 hours. However, be careful not to exceed 4 tablets in a 24-hour period. If you have children under 12, this medication is not suitable for them, so please avoid using it for that age group.

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 avoid using 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 a lot of mucus, it's important to consult a doctor before using this product.

If your cough lasts more than seven 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. In the event of an overdose, please contact a medical professional or the Poison Control Center at 1-800-222-1222 immediately.

Warnings and Precautions

You should not use 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 comes with a lot of mucus, please consult your doctor before using it. It's important to stop using the medication 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 could indicate a more serious health issue.

If you are pregnant or breastfeeding, make sure to talk to 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.

Don’t wait to see if symptoms improve; getting prompt assistance can be vital for your safety. Always err on the side of caution and reach out for help if you think an overdose has occurred.

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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 (liver issues).

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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that your treatment is as safe and effective as 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 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.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and reliable for your needs.

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 medication with a full glass of water and not crush, chew, or break the tablet. It can be taken without regard for meals.

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

Adults and children 12 years of age and over can take 1 or 2 tablets every 12 hours, not exceeding 4 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 should I do in case of an overdose?

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

Are there any warnings I should be aware of?

Yes, ask a doctor before use if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive phlegm.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this medication.

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 data.

Uses and Indications

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

Dosage and Administration

Patients should take the tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to administration. 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 or 2 tablets every 12 hours. The total daily dosage should not exceed 4 tablets within a 24-hour period.

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

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

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 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.

Side Effects

Patients should be aware of the following 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 the 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.

In the event of an overdose, it is crucial to obtain medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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 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. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

There is no specific information available 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 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 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 prescribing 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, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks and complications associated with the overdose.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

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; specifically, it should 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.