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Refenesen 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 2021
Label revision date
December 18, 2024
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 2021
Label revision date
December 18, 2024
Manufacturer
Reese Pharmaceutical Co
Registration number
M012
NDC root
10956-845
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

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it helps make your coughs more productive, allowing you to expel bothersome mucus more effectively. If you're dealing with congestion or a persistent cough, this drug can provide relief by improving your ability to breathe comfortably.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways.

Additionally, it makes your coughs more productive, meaning that when you do cough, it can help you expel mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

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 needed for relief. For children between the ages of 6 and 10, the recommended dose is 1/2 tablet every 4 hours as needed. However, if your child is under 6 years old, it’s important to consult a doctor before giving them any medication.

Make sure not to exceed 6 doses in a 24-hour period, unless your doctor advises otherwise. This helps ensure safe and effective use of the medication. Always follow these guidelines to manage your or your child's symptoms properly.

What to Avoid

It's important to be aware of certain situations when using this medication. You should stop using it and consult your doctor if you experience symptoms like fever, rash, or a persistent headache. Additionally, if your cough lasts more than a week or keeps coming back, it's essential to seek medical advice.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize your health and safety by following these guidelines.

Side Effects

If you are considering using this medication, it's important to consult your doctor first if you have a persistent or chronic cough, especially if it’s related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough comes with excessive mucus, you should also seek medical advice.

You should stop using the medication and contact your doctor if you experience symptoms like fever, rash, or a persistent headache. If your cough lasts more than a week or keeps coming back, it may 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 long-lasting cough due to smoking, asthma, bronchitis, or emphysema, especially if your cough comes with a lot of mucus.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away. Additionally, you should stop taking the medication and call your doctor if you experience symptoms like fever, rash, or a persistent headache. If your cough lasts more than a week or keeps coming back, it could indicate a more serious health issue that needs attention.

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 symptoms like confusion, extreme drowsiness, or difficulty breathing.

Always act quickly—time is important in these situations. If you notice any of these symptoms or have concerns about an overdose, don’t hesitate to reach out for professional assistance. 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 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 follow the appropriate dosage guidelines based on their age. For children aged 12 and older, the recommended dose is 1 tablet every 4 hours as needed. For those between 6 and 10 years old, the dosage is reduced to 1/2 tablet every 4 hours.

For children under 6 years of age, you should consult a doctor before administering this medication. Regardless of age, do not exceed 6 doses in a 24-hour period unless directed by a healthcare professional. Always prioritize your child's safety by adhering to these guidelines.

Geriatric Use

While there is no specific information about how Refenesin Mucus Relief (guaifenesin) should be used by older adults, it’s always important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this medication. They can help ensure that it is appropriate for your needs and discuss any potential interactions with other medications you may be taking.

If you or a loved one are considering this medication, be sure to share your complete medical history and any current health conditions with your doctor. This will help them provide the best advice tailored to your situation.

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 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 want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 15°-30°C (59°-86°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You can take this medication as follows: Adults and children aged 12 and older should take 1 tablet every 4 hours as needed. For children aged 6 to 10, the recommended dose is 1/2 tablet every 4 hours as needed. If your child is under 6 years old, it's important to consult a doctor before giving them this medication. Remember not to exceed 6 doses in a 24-hour period unless directed by a doctor.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

FAQ

What does this drug do?

This drug 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 of age and over should take 1 tablet every 4 hours as needed, not exceeding 6 doses in a 24-hour period.

What is the recommended dosage for children aged 6 to 10?

Children aged 6 to 10 should take 1/2 tablet every 4 hours as needed, also not exceeding 6 doses in a 24-hour period.

What should I do if my child is under 6 years old?

If your child is under 6 years of age, you should consult a doctor before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I experience side effects?

Stop use and ask a doctor if symptoms are accompanied by fever, rash, or persistent headache, or if a cough persists for more than 1 week.

Should I consult a doctor before using this drug?

Yes, you should 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 immediately.

Is this drug safe to use during pregnancy or breastfeeding?

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

How should I store this drug?

Store the drug at 15°-30°C (59°-86°F).

Packaging Info

Below are the non-prescription pack sizes of Refenesen Mucus Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Refenesen Mucus Relief.
Details

Drug Information (PDF)

This file contains official product information for Refenesen Mucus Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication aids in making coughs more productive.

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 as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that parents or guardians consult a doctor for children under 6 years of age before administration.

Healthcare professionals should advise patients not to exceed 6 doses in a 24-hour period, unless otherwise directed by a physician.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

In the event of an overdose, it is imperative to obtain emergency medical assistance or contact a Poison Control Center immediately.

Patients are advised to discontinue use and consult their healthcare provider if any of the following occur: symptoms are accompanied by fever, rash, or a persistent headache; the cough persists for more than one week; or if the cough tends to recur. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

It is important for patients to discontinue use and contact a healthcare provider if they experience symptoms such as fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, medical evaluation is warranted, as a persistent cough may indicate a serious underlying condition.

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 Refenesen Mucus Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Refenesen Mucus Relief.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 tablet every 4 hours as needed, with a maximum of 6 doses in a 24-hour period or as directed by a physician. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed, also not to exceed 6 doses in a 24-hour period or as directed by a healthcare provider.

For children under 6 years of age, consultation with a doctor is advised prior to administration.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Refenesin Mucus Relief (guaifenesin tablet). As there is no dedicated information regarding geriatric use, healthcare providers should exercise caution when prescribing this medication to patients aged 65 and older.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations for this population. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when determining the appropriateness of treatment with this medication in geriatric patients.

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. 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 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

There is no specific information available 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 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 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 overdosage.

Healthcare professionals are advised to monitor the patient closely for any symptoms that may arise as a result of the overdose. The specific symptoms can vary depending on the substance involved, and a thorough assessment is necessary to determine the appropriate course of action.

Management of an overdose typically involves supportive care and may require specific interventions based on the clinical presentation. It is essential for healthcare providers to remain vigilant and prepared to implement necessary treatment protocols to ensure patient safety and recovery.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 medication; they should be instructed to stop use and consult their doctor if they experience symptoms such as fever, rash, or a persistent headache.

Additionally, patients should be informed that if their cough persists for more than one week or tends to recur, they should also stop use and consult their healthcare provider. A persistent cough may indicate a serious underlying condition, and timely medical evaluation is essential.

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 temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours as needed, while children aged 6 to 10 years should take 1/2 tablet every 4 hours as needed. For children under 6 years of age, consultation with a doctor is recommended. It is important for patients not to exceed 6 doses within a 24-hour period unless directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Refenesen 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 Refenesen 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.