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Mucus Relief

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This product has been discontinued

Active ingredient
Guaifenesin 400 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
April 12, 2024
Active ingredient
Guaifenesin 400 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
April 12, 2024
Manufacturer
NewVue LLC
Registration number
M012
NDC root
83813-003

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Drug Overview

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive. By doing so, it aids in clearing the bronchial passageway of bothersome mucus, which can help you breathe more easily.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. When you have a cough, this can make it more productive, allowing you to clear out bothersome mucus from your bronchial passageways.

By improving the effectiveness of your cough, this treatment can help you feel more comfortable and support your respiratory health.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed while your symptoms last. 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.

For children under 12 years of age, this medication is not recommended, so please do not use it for younger children. 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, it's advised not to use this medication for more than 7 days. Following these guidelines will help you avoid potential risks and ensure the medication works effectively for you.

Side Effects

When using this product, it's important to be aware of certain side effects and warnings. You should consult a doctor if you have a persistent cough, especially if it’s related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus. It's crucial not to exceed the recommended dosage or use the product 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 seek medical advice, as these could indicate a more serious condition. If you are pregnant or breastfeeding, please consult a healthcare professional before use. Always keep this product out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center.

Warnings and Precautions

Before using this medication, 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.

Make sure to follow the recommended dosage and do not use this medication 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 medication and contact your doctor, as these could indicate a more serious issue.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately. Your health and safety are paramount, so please take these precautions seriously.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning after taking medication, don’t hesitate to reach out for assistance. Your health and safety are 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

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. For those who are 12 years and older, the dosage is one tablet every four hours as needed, accompanied by a full glass of water. However, be cautious not to exceed six doses within a 24-hour period to ensure safety and effectiveness. 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, it’s important to consult with a healthcare provider for personalized advice. 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 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 may affect you if you have hepatic impairment (liver issues).

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

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 room temperature, ideally around 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F), but make sure to keep it in a dry place and away from heat sources.

When handling the product, check the safety seal under the cap before use. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help maintain the product's integrity and safety.

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 to clear the bronchial passageway.

How should adults and children 12 years and over take this drug?

You should take 1 tablet every 4 hours with a full glass of water while symptoms persist, but do not exceed 6 doses in 24 hours.

Is this drug safe for children under 12 years?

No, this drug 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 drug and ask a doctor if your cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Are there any warnings before using this drug?

Yes, ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by excessive phlegm (mucus).

What should I do in case of overdose?

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

Can I use this drug if I am pregnant or breastfeeding?

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

How should I store this drug?

Store the drug at 25°C (77°F) with excursions between 15°-30°C (59°-86°F) in a dry place, and do not expose it to heat.

Packaging Info

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

This product is available in a quantity of 300 count.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions. 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 over are instructed to take 1 tablet every 4 hours with a full glass of water, as needed while symptoms persist. It is important not to exceed 6 doses within a 24-hour period.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

There are no specific contraindications listed 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 use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

It is imperative to adhere to the recommended dosage and not to exceed the specified duration of use, which should not exceed 7 days. Prolonged use may lead to adverse effects and is not advised.

Patients must 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 overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is advised to consult a healthcare professional prior to use if there is a history of persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before using this product.

While using this product, it is crucial not to exceed the recommended dosage and to limit use to no more than 7 days. Patients are instructed to discontinue use and consult a healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a health professional before using this product. Furthermore, it is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 400 mg). 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

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. 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 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 or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 in the event of an overdose. It is important for patients to be aware of the signs that warrant discontinuation of the product; they should stop 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 should be instructed to adhere strictly to the recommended dosage and to avoid exceeding it while using this product. Additionally, healthcare providers should inform patients that the product should not be used for more than 7 days to ensure safety and efficacy.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

The product must be kept in a dry environment, ensuring that it is not exposed to heat or moisture, which could compromise its integrity. Additionally, it is crucial to observe the tamper-evident feature; the product should not be used if the imprinted safety seal under the cap is broken or missing. Proper adherence to these storage and handling guidelines will help maintain the product's quality and efficacy.

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.