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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 13, 2024
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 13, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M012
NDC root
68210-4173
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 mucus in your airways. It works by loosening phlegm (a type of mucus) and thinning bronchial secretions, making it easier for you to clear out bothersome mucus from your bronchial passageways. This can help make your coughs more productive, allowing you to breathe more comfortably.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a type of 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 respiratory issues that involve excess mucus.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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 to help it work effectively.

For adults and children aged 12 years and older, you should take 1 tablet every 4 hours as long as your symptoms continue. However, be careful not to exceed 6 tablets in a 24-hour period. If you have children under 12 years of age, this medication is not recommended for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should be aware of a few important guidelines regarding your health. If your cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache, it’s crucial to stop using the medication and consult your doctor. These symptoms could indicate a more serious illness that requires medical attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence related to this medication. However, always prioritize your health and seek professional advice if you have any concerns.

Side Effects

If you are considering using this medication, it's important to be aware of some potential side effects and warnings. You should not use this medication if you are under 12 years of age. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these symptoms may indicate a more serious condition.

Additionally, if you have a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, it's advisable to speak with your doctor before using this medication.

Warnings and Precautions

It’s important to know that this medication should not be used in children under 12 years of age. If you or someone you know takes too much of this medication, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop taking this medication and call your doctor if your cough lasts more than 7 days, returns after improvement, or occurs alongside fever, rash, or a persistent headache. These symptoms could indicate a more serious health issue that needs attention.

Overdose

If you suspect an overdose, it's important to stay calm and take action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe an overdose has occurred, seek immediate medical help. It's always better to err on the side of caution when it comes to your health. Remember, if you're ever in doubt, contacting a healthcare professional is the best course of action.

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 about the appropriate 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 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 your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, a lower dose of your medication should be considered. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your kidney function.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, follow them carefully to ensure safe and responsible disposal.

Additional Information

You should take this medication orally, with adults and children aged 12 and older advised to take 1 tablet every 4 hours as needed while symptoms persist. It's important not to exceed 6 tablets in a 24-hour period, and you should always take the tablet with a full glass of water. If you have any questions or concerns about your treatment, be sure to consult your healthcare provider.

FAQ

What is Mucus Relief used for?

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

How should I take Mucus Relief?

You should take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours.

Who should not use Mucus Relief?

Mucus Relief 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 Mucus Relief and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Are there any teratogenic effects associated with Mucus Relief?

No teratogenic effects are mentioned for Mucus Relief.

What should I do in case of an overdose?

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

Can I take Mucus Relief if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Mucus Relief.

What are the storage conditions for Mucus Relief?

Store Mucus Relief between 20-25°C (68-77°F).

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

Mucus Relief is provided in a pouch format, designed for ease of use and convenience. The formulation is intended to alleviate symptoms associated with mucus buildup. The pouch contains a specific blend of active ingredients aimed at providing effective relief.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of bothersome mucus from the bronchial passageways.

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

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 to ensure proper swallowing and absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed while symptoms persist. 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

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Patients should not use this medication in children under 12 years of age due to safety concerns.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients are instructed to discontinue use and consult their healthcare provider if a 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 further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated for children under 12 years of age.

In clinical practice, patients are advised to 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.

Additionally, patients should seek medical advice prior to using this medication if they have a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema.

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. 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, 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe renal impairment.

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 context of overdosage, it is important to note that there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the individual patient's circumstances when faced with a potential overdosage scenario.

In the absence of detailed guidance, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and guidance on management strategies.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and 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 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature between 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

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. Patients should not exceed six tablets within a 24-hour period. 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.