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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 2014
Label revision date
May 5, 2021
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 2014
Label revision date
May 5, 2021
Manufacturer
Good Sense
Registration number
M012
NDC root
50804-371
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

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. 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 can take 1 tablet every 4 hours as long as your symptoms continue. 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 doses in a 24-hour period to avoid any potential issues.

For children under 12 years of age, this medication is not recommended, so please do not use it for younger kids. 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

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 due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive phlegm (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.

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 important 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

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 a healthcare professional before using any medication. This is to ensure that it is safe for you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your healthcare team regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering medication for children. If your child is under 12 years old, you should not use this medication. For those aged 12 and older, the recommended dosage is one tablet every four hours, taken with a full glass of water, as long as symptoms continue. However, do not exceed six doses in a 24-hour period.

Always keep this medication out of reach of younger children. In the event of an accidental overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your child's safety is the top priority, so please follow these guidelines carefully.

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 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 should be used if you have hepatic impairment (issues with liver function).

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 way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

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

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that you use the product safely and effectively.

Additional Information

You should take this medication orally, with a full glass of water. If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed while symptoms persist, 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.

FAQ

What is Mucus Relief used for?

Mucus Relief helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive to clear the bronchial passageway of bothersome mucus.

How should adults and children 12 years and older take Mucus Relief?

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.

Can children under 12 years of age 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 warnings before using Mucus Relief?

Yes, 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 excessive phlegm.

What should I do in case of accidental overdose?

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

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.

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.

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 therapeutic agent designed to alleviate symptoms associated with excessive mucus production. The formulation is effective as of May 5, 2021. Visual representations of the product are available, including two images labeled as 370---mucus-relief-1.jpg and 370---mucus-relief-2.jpg.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing productive coughs associated with respiratory conditions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the effectiveness of coughs to expel bothersome mucus from the bronchial passageways.

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 not to exceed 6 doses 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:

  • The recommended dosage should not be exceeded to avoid potential adverse effects.

  • The product should not be used for more than 7 days to mitigate the risk of complications or diminished efficacy.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product 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 use.

When utilizing this product, it is imperative to adhere to the recommended dosage and to limit use to a maximum of 7 days. Exceeding the recommended dosage or extending the duration of use beyond this timeframe may lead to adverse effects.

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 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. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should discontinue use and consult a healthcare professional if a 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.

Before initiating treatment, patients are advised to seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, a consultation is recommended for those experiencing a cough accompanied by excessive phlegm (mucus).

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 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 as needed, with a full glass of water, not to exceed 6 doses in a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances and any potential risks with their healthcare provider before initiating treatment.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. 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 considering the use of this medication during lactation.

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.

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 should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt intervention is crucial in managing potential overdose situations, as timely medical help can significantly mitigate risks and complications associated with excessive intake. It is essential for healthcare providers to be aware of the appropriate steps to take in such scenarios to ensure patient safety and effective management.

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 accidental overdose. It is important for patients to understand the significance of monitoring their symptoms; they should be instructed to stop using the product and consult a doctor if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients must be reminded 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, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical guidance 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.

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.