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Mucus Relief

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
March 5, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Film Coated
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 2024
Label revision date
March 5, 2026
Manufacturer
Amerisource Bergen
Registration number
M012
NDC root
46122-794
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

Guaifenesin is a medication commonly used to relieve mucus buildup in the airways. It acts as an expectorant, which means it helps loosen phlegm (mucus) and thin bronchial secretions. This action makes it easier for you to cough up the mucus, leading to more productive coughs and clearer airways.

Typically available in a 400 mg dosage, Guaifenesin is designed for immediate release, providing quick relief from congestion. If you're dealing with a cough caused by mucus, Guaifenesin may help you feel more comfortable by clearing out the bothersome mucus from your bronchial passageways.

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.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, make sure not to exceed 6 tablets in a 24-hour period.

If you have children under 12 years old, this medication is not recommended for them, so please avoid using it for that age group. Always remember to take only the directed amount to prevent any potential risks.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your cough lasts more than a week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention. Always prioritize your health and seek professional advice when needed.

Side Effects

If you experience a cough that lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, it's important to stop using the medication and consult your doctor. These symptoms could indicate a more serious health issue that needs attention.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a cough that produces a lot of phlegm (mucus) or if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema.

You should stop using the medication and contact your doctor if your cough lasts more than a week, comes back frequently, or is accompanied by a fever, rash, or a persistent headache, as these may indicate a more serious health issue. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication. Always keep this product out of reach of children to ensure their safety.

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, don’t hesitate to reach out for professional 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

It's important to be cautious when considering this medication for children. If your child is under 12 years old, you should not use this medication for them. For those aged 12 and older, the recommended dosage is one tablet every four hours, but make sure not to exceed six tablets in a 24-hour period.

Always keep this medication out of reach of younger children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center for assistance. 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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically at 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F) occasionally. Always check the end flap of the packaging for the expiration date and lot number, as this information is crucial for safety and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, but do not exceed 6 tablets in a 24-hour period. If you are caring for a child under 12 years old, do not use this medication for them. Always follow the dosage instructions to ensure safe and effective use.

FAQ

What is Guaifenesin used for?

Guaifenesin is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

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

Adults and children 12 years and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

Can children under 12 use Guaifenesin?

No, Guaifenesin should not be used by children under 12 years.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Are there any warnings before using Guaifenesin?

Yes, consult a doctor if you have a cough accompanied by too much phlegm, or if you have a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema.

What should I do in case of an overdose?

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

Is Guaifenesin safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should Guaifenesin be stored?

Store Guaifenesin at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

What should I check before using Guaifenesin?

Ensure the tamper-evident safety seal under the cap is intact before use.

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 specified drug.

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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and not exceed the directed amount.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed. It is important to note that no more than 6 tablets should be taken within a 24-hour period.

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

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

It is essential for healthcare professionals to be aware of the following warnings and precautions associated with the use of this medication.

Patients should be advised to consult a physician prior to use if they present with a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate a different therapeutic approach.

Should a patient experience a cough that persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, it is imperative to discontinue use and seek medical advice. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay to ensure appropriate management.

General precautions must also be observed. Pregnant or breastfeeding individuals should consult a healthcare professional before using this medication to assess potential risks and benefits.

Finally, it is crucial to keep this medication out of the reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should discontinue use and consult a healthcare professional if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires medical evaluation.

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 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 adverse effects or changes in therapeutic response, 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

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

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, with a maximum of six tablets in a 24-hour period. Use is not recommended for children under 12 years of age.

There is no additional information 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.