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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)
Marketed in the U.S.
Since 2014
Label revision date
January 21, 2021
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
Marketed in the U.S.
Since 2014
Label revision date
January 21, 2021
Manufacturer
TopCo Associates, LLC
Registration number
M012
NDC root
76162-004

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

Mucus Relief is a medication designed to help you manage coughs by loosening phlegm (mucus) and thinning bronchial secretions. This action makes your coughs more productive, allowing you to clear bothersome mucus from your bronchial passageways more effectively. If you're dealing with congestion or a persistent cough, Mucus Relief can support your body's natural process of clearing out mucus.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear out bothersome mucus from your bronchial passageways. This can be particularly helpful if you're dealing with a cough that feels unproductive or if you're experiencing congestion.

You can feel confident using this medication, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with it.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed while you have symptoms. It's important to drink a full glass of water with each tablet to help it work effectively. However, make sure not to take more than 6 tablets in a 24-hour period to avoid any potential side effects.

If you have a child under 12 years of age, this medication is not recommended for them. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, avoid using this medication for more than 7 days, as prolonged use may not be safe.

By following these guidelines, you can help prevent potential issues and ensure that the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

If you experience a cough that lasts more than 7 days, comes back, 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 serious condition.

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

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough comes with excessive phlegm (mucus), seek medical advice first.

While using this product, make sure to follow the recommended dosage and do not use it for more than 7 days. If your cough lasts longer than 7 days, comes back, or is accompanied by symptoms like fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may indicate a more serious condition.

In the event of an accidental overdose, it’s crucial to get emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an accidental 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 planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using any medication. They can provide guidance on the safety and potential effects on both you and your baby. Always prioritize open communication with your doctor to ensure the best outcomes for you and your nursing infant.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age. For those who are 12 years and older, the recommended dosage is one tablet every four hours, taken with a full glass of water, as long as symptoms continue. However, be careful not to exceed six doses in a 24-hour period. Always consult with a healthcare professional if you have any questions or concerns about using 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 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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition 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 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 you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F), allowing for brief fluctuations between 15°C to 30°C (59°F to 86°F). It's important to keep the product in a dry location and avoid exposing it to heat, as this can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 hours as needed, but do not exceed 6 doses in a 24-hour period. If you are caring for a child under 12 years of age, do not use this medication for them. Always take the tablet with a full glass of water while symptoms persist.

FAQ

What is Mucus Relief used for?

Mucus Relief helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, aiding in the removal of bothersome mucus from the bronchial passageway.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years of age and older should take 1 tablet every 4 hours with a full glass of water while symptoms persist, not exceeding 6 doses in 24 hours.

Can children under 12 years use Mucus Relief?

No, Mucus Relief should not be used by children under 12 years of age.

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

You should stop using Mucus Relief and ask a doctor if your cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Are there any contraindications for using Mucus Relief?

No specific contraindications are mentioned for Mucus Relief in the provided information.

What precautions should I take when using Mucus Relief?

Do not exceed the recommended dosage and do not use Mucus Relief for more than 7 days without consulting a doctor.

Is there any information about using Mucus Relief during pregnancy or breastfeeding?

You should ask a healthcare professional before using Mucus Relief if you are pregnant or breastfeeding.

How should Mucus Relief be stored?

Store Mucus Relief at 25°C (77°F) with excursions between 15° to 30°C (59° to 86°F) in a dry place, away from heat.

Packaging Info

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin 400mg). 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

Mucus Relief is a pharmaceutical formulation designed to alleviate symptoms associated with excessive mucus production. It is indicated for use in conditions where mucus clearance is necessary. The product is characterized by its active ingredients that target mucus viscosity and promote expectoration. Mucus Relief is available in a dosage form suitable for administration, ensuring effective delivery of its therapeutic benefits. The formulation is designed to provide relief from discomfort caused by mucus accumulation, thereby improving respiratory function.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions characterized by excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby making coughs more productive and aiding in the expulsion of bothersome mucus from the bronchial passageway.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours as needed while symptoms persist. It is essential to administer the tablet with a full glass of water. The maximum allowable dosage is 6 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following guidelines to ensure safe use:

  • Do not exceed the recommended dosage, as this may lead to adverse effects.

  • Do not use the product for more than 7 days to prevent potential complications associated with prolonged use.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product if they have a persistent or chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before use.

When utilizing this product, it is imperative to adhere to the recommended dosage and not to exceed it. Furthermore, the product should not be used for a duration exceeding 7 days. Prolonged use may lead to adverse effects or mask underlying conditions.

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

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be advised to stop use and consult a doctor if a cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, it is recommended that patients seek medical advice before using the product if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with a cough accompanied by excessive phlegm (mucus) should also consult a healthcare professional prior to use.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief (guaifenesin 400mg). 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 medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours with a full glass of water, as needed while symptoms persist. It is important not to exceed 6 doses in a 24-hour period.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure appropriate management during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare 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 accidental 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 accidental overdose. It is important for patients to be aware that they should discontinue use and consult a doctor if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients must be instructed not to exceed the recommended dosage while using this product and to limit its use to no more than 7 days. Additionally, healthcare providers should encourage patients to consult a doctor prior to use if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should 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 upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

It is essential to keep the product in a dry place and to avoid exposure to heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product remains within the specified temperature range.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, with a full glass of water, not to exceed six doses within a 24-hour period. The use of this medication is not recommended for children under 12 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.

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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.