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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 2025
Label revision date
September 26, 2025
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 2025
Label revision date
September 26, 2025
Manufacturer
HealthLife of USA LLC
Registration number
M012
NDC root
69517-005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

You may find this medication helpful for providing temporary relief from symptoms associated with a congested chest and cough. It is designed to ease discomfort and make breathing easier when you're feeling under the weather. If you're experiencing these symptoms, this drug could be a supportive option to consider.

Uses

If you're dealing with a congested chest and a persistent cough, this medication can provide temporary relief from these symptoms. It works by helping to ease the discomfort associated with chest congestion, making it easier for you to breathe and feel more comfortable. Remember, this relief is temporary, so it's important to consult with a healthcare professional if your symptoms persist or worsen.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take one caplet each day. It’s important to remember not to exceed four doses within a 24-hour period, as taking more than this can be harmful.

For children under 12 years of age, this medication is not recommended, so please avoid using it for younger children. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when using this medication. You should avoid consuming alcohol, benzodiazepines (a type of medication often used for anxiety), or opioids (strong pain relievers) while taking it, as these substances can increase the risk of serious side effects. Additionally, make sure not to exceed the recommended dosage, as doing so can lead to harmful consequences.

While there are no specific contraindications or dependence concerns mentioned, being mindful of these guidelines will help ensure your safety and the effectiveness of your treatment. Always consult with your healthcare provider if you have any questions or concerns.

Side Effects

If you experience a persistent cough that lasts more than a week, recurs frequently, or is accompanied by symptoms like fever, rash, or a persistent headache, it's important to consult a doctor, as this may indicate a serious condition. Additionally, if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus, you should speak with a healthcare professional before using this medication.

If your cough continues for more than 7 days, please stop using the medication and seek medical advice. In the event of an overdose, contact a medical professional or the Poison Control Center at 1-800-222-1222 immediately.

Warnings and Precautions

If you have a persistent cough that lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a lasting headache, it’s important to see a doctor as this could indicate a serious condition. Before using this product, consult your doctor if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with a lot of mucus.

While using this product, make sure to follow the recommended dosage and avoid alcohol, benzodiazepines (a type of sedative), or opioids (strong pain relievers). If your cough continues for more than 7 days, stop using the product and reach out to your healthcare provider. In case of an overdose, seek 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.

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 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 caplet per day. Always follow these guidelines to ensure the safety and well-being of your child. If you have any questions or concerns, consult with your healthcare provider.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any medications with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any potential risks are managed effectively. Always keep an open line of communication with your doctor about any concerns or side effects you may experience.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally around 25°C (77°F), but it can safely be kept in a range between 15°-30°C (59°-86°F). Make sure to keep it in a dry place and avoid exposing it to heat, as this can affect its effectiveness.

When handling the product, always check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may not be safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug provides temporary symptomatic relief from congested chests and cough.

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

Adults and children 12 years of age and over should take 1 caplet a day.

Can children under 12 use this drug?

No, children under 12 years should not use this drug.

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

If your cough lasts for more than 7 days, you should consult your physician or healthcare provider.

Are there any substances I should avoid while using this drug?

You should not consume alcohol, benzodiazepines, or opioids while using this drug.

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.

Is it safe to 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.

What should I do if I have a persistent cough?

If you have a persistent cough that lasts more than a week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

How should I store this drug?

Store the drug at 25°C (77°F), keeping it in a dry place and avoiding exposure to heat.

What should I check before using this drug?

You should ask a doctor before use if you have a persistent or chronic cough, or if your cough is accompanied by excessive phlegm.

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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary symptomatic relief of congested chests and cough. It is intended for use in patients experiencing these symptoms, providing a short-term solution to alleviate discomfort associated with respiratory congestion.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 caplet once daily. For children under 12 years of age, the use of this medication is not recommended. It is essential to adhere to the maximum dosage limit, which should not exceed 4 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in patients who consume alcohol, benzodiazepines, or opioids due to the potential for adverse interactions. Additionally, exceeding the recommended dosage is contraindicated, as it may lead to increased risk of side effects or complications.

Warnings and Precautions

A persistent cough may indicate a serious underlying condition. Healthcare professionals should advise patients to seek medical consultation if a cough persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

Prior to recommending this product, it is essential to inquire about the patient's medical history. Patients with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should be advised to consult a physician before use. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice.

When utilizing this product, it is critical to adhere to the recommended dosage guidelines. Patients should be cautioned against the consumption of alcohol, benzodiazepines, or opioids during treatment, as these substances may exacerbate potential side effects.

If a cough persists beyond seven days, patients must be instructed to discontinue use and consult their healthcare provider for further evaluation. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important to note that a persistent cough may indicate a serious underlying condition. If a cough persists for more than one week, recurs frequently, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients are advised to consult a healthcare professional.

Patients with a history of persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this medication. Additionally, if a cough is accompanied by excessive phlegm (mucus), it is recommended that patients consult a doctor prior to use.

In the event that a cough lasts longer than seven days, patients should discontinue use and seek medical attention. Furthermore, in cases of overdose, immediate medical assistance should be sought, or patients should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 use this medication. For adolescents aged 12 years and older, the recommended dosage is one caplet per day.

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, 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 the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

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 develop 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 overdose. It is important for patients to be informed that they should discontinue use and consult their physician or healthcare provider if their cough persists for more than 7 days.

When using this product, patients must be cautioned not to exceed the recommended dosage. Additionally, they should be advised against the consumption of alcohol, benzodiazepines, or opioids while using this medication.

Healthcare providers should also 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 advice if their cough is accompanied by excessive phlegm (mucus).

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 place, 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 safety seal under the cap is broken or missing, as this indicates potential contamination or compromise of the product.

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.