Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Muca Clear

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Guaifenesin 200 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 2020
Label revision date
October 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 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 2020
Label revision date
October 15, 2024
Manufacturer
Schwabe North America, Inc
Registration number
M012
NDC root
59800-1365
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 helps loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, it can help make your coughs more productive, allowing you to breathe more comfortably. If you're dealing with congestion or a cough, this medication may assist in relieving those symptoms by promoting better mucus clearance from your lungs.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear your bronchial passageways of mucus, making your coughs more productive. This can be particularly beneficial if you're dealing with conditions that cause excessive mucus production, as it aids in clearing your airways and improving your overall respiratory function.

Rest assured, there are no 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

If you are an adult or a child aged 12 years and older, you can take 1 to 2 tablets every 4 hours as needed. However, make sure not to exceed a total of 12 tablets in a 24-hour period. For children between the ages of 6 and 11, the recommended dosage is ½ to 1 tablet every 4 hours, with a maximum of 6 tablets in a day.

If your child is under 6 years old, it’s important to consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

If you are using this medication, it's important to know when to stop. You should stop using it 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 signs could indicate a more serious condition that needs medical attention. Always prioritize your health and seek guidance if you have any concerns.

Side Effects

You should be aware of some important warnings and potential side effects associated with this product. It is not recommended for use if you are pregnant, trying to become pregnant, or breastfeeding. Additionally, avoid using it for a persistent or chronic cough, especially if it is related to smoking, asthma, chronic bronchitis, or emphysema, unless directed by a doctor.

If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, you should stop using the product and consult a doctor, as these could be signs of a more serious condition. It's also a good idea to talk to your doctor before using this product if you have a chronic cough, diabetes, or are taking other medications.

Warnings and Precautions

You should avoid using this product if you are pregnant, trying to become pregnant, or breastfeeding. Additionally, do not take it for a long-lasting cough caused by smoking, asthma, chronic bronchitis, or emphysema, especially if you have a lot of mucus, unless your doctor advises you to do so.

If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, stop using the product and consult your doctor. A lasting cough could indicate a more serious health issue that needs attention.

Overdose

If you suspect an overdose, it’s crucial to seek medical help right away or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help if you think an overdose has occurred.

Pregnancy Use

If you are pregnant, trying to become pregnant, or breastfeeding, it is important to avoid using this product. The potential risks to your health and the health of your baby are significant, and it is best to prioritize safety during this time. Always consult with your healthcare provider for guidance on medications and treatments that are safe for you and your baby.

Lactation Use

If you are breastfeeding, it is important to avoid using this product. The safety of this medication during breastfeeding has not been established, and it may pose risks to you and your nursing infant. Always consult with your healthcare provider for guidance on safe options while you are nursing. Your health and the well-being of your baby are paramount, so make informed choices regarding any medications you consider.

Pediatric Use

When giving this medication to children aged 6 to 11 years, you should administer ½ to 1 tablet every 4 hours, but be careful not to exceed 6 tablets in a 24-hour period. For children under 6 years old, it’s important to consult a doctor before using this medication to ensure it’s safe and appropriate for their age. Always follow these guidelines to help keep your child safe and healthy.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 you understand how your kidney health may affect your medication and what steps to take for your safety.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are currently taking any other medications. This is to ensure that there are no potential interactions that could affect how well the medication works or increase the risk of side effects.

While there are no specific laboratory test interactions noted, discussing all aspects of your health and any tests you may undergo with your doctor is always a good practice. Open communication helps ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

This medication is taken orally. It's important to avoid using it if you are pregnant, trying to become pregnant, or breastfeeding. Before using this product, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, especially if your cough produces a lot of mucus. Additionally, if you have diabetes or are taking other medications, it's wise to check with your healthcare provider first.

If your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, stop using the medication and seek medical advice.

FAQ

What is the main use of this medication?

This medication helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

What should I do if my cough persists for more than a week?

You should stop using the medication and ask a doctor if your cough persists more than one week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Can I use this medication if I am pregnant or breastfeeding?

No, you should not use this product if you are pregnant, attempting to be pregnant, or breastfeeding.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years of age and older should take 1-2 tablets every 4 hours, not to exceed 12 tablets in 24 hours.

What is the dosage for children aged 6 to 11 years?

Children aged 6 to 11 years should take ½ to 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours.

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

Consult a doctor before using this medication for children under 6 years of age.

Are there any contraindications for this medication?

No specific contraindications are mentioned in the provided information.

What should I do if I have a chronic cough?

Ask a doctor before use if you have a persistent or chronic cough, especially if it is associated with smoking, asthma, chronic bronchitis, or emphysema.

How should I store this medication?

Store at room temperature, 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Muca Clear.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LZP13653.H02-Muca-Clear is identified by the SPL code 34089-3. The product is available in a dosage form of 100 tablets. The appearance of the tablets is depicted in the associated image file, LZP13653.H02-Muca-Clear-(OTC)-100-tabs.jpg.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions characterized by excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of 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 advised to take 1 to 2 tablets every 4 hours, with a maximum dosage not to exceed 12 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is ½ to 1 tablet every 4 hours, ensuring that the total does not exceed 6 tablets in a 24-hour timeframe.

In the case of children under 6 years of age, it is essential to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache. In such cases, it is advised to discontinue use and consult a healthcare professional for further evaluation.

Warnings and Precautions

The use of this product is contraindicated in individuals who are pregnant, attempting to conceive, or currently breastfeeding. Healthcare professionals should advise patients against using this product in these circumstances to avoid potential risks to the mother and child.

This product is not indicated for the treatment of persistent or chronic coughs, including those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, it should not be used when cough is accompanied by excessive phlegm (mucus) unless specifically directed by a healthcare provider. Such conditions may require alternative therapeutic approaches and careful evaluation by a physician.

Patients should be instructed to discontinue use and consult a healthcare professional if the cough persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that necessitates further medical assessment and intervention. Regular monitoring and appropriate laboratory tests may be warranted based on the clinical presentation and history of the patient.

Side Effects

Patients should be aware of several important warnings and recommendations regarding the use of this product. It is contraindicated for individuals who are pregnant, attempting to become pregnant, or breastfeeding. Additionally, the product should not be used for persistent or chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema, nor should it be used when cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare professional.

Patients are advised 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. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). Additionally, individuals with diabetes or those currently taking other medications should consult a healthcare provider prior to use.

Drug Interactions

Patients are advised to consult a healthcare professional prior to using this medication if they are currently taking any other medications. This precaution is essential to ensure safety and efficacy, as potential drug interactions may occur.

There are no specific laboratory test interactions associated with this medication. However, it remains important for healthcare providers to consider the overall medication regimen of the patient when interpreting laboratory results. Regular monitoring may be warranted based on the patient's complete clinical picture and concurrent therapies.

Packaging & NDC

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

Packaging configurations for Muca Clear.
Details

Pediatric Use

Pediatric patients aged 6 to 11 years may take ½ to 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. For children under 6 years of age, it is advised to consult a doctor before use.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients, those attempting to become pregnant, or breastfeeding individuals should not use this product. The potential risks associated with the use of this product during pregnancy have not been established, and its safety profile in this population remains unclear. Therefore, healthcare professionals are advised to counsel patients on the importance of avoiding this product during pregnancy and while breastfeeding to prevent any potential adverse effects on fetal outcomes or infant health.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. There is no available data on the excretion of the product in human milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

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

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. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Monitoring the patient for any adverse effects is essential, as timely intervention can significantly impact the outcome.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and provide appropriate interventions based on the severity of symptoms and the substance involved. Continuous monitoring and evaluation are recommended to address any complications that may arise during the management process.

Nonclinical Toxicology

The use of this product is contraindicated in individuals who are pregnant, attempting to become pregnant, or breastfeeding due to potential teratogenic effects. No specific non-teratogenic effects or additional nonclinical toxicology details have been provided. Furthermore, there are no specific findings related to animal pharmacology and toxicology available in the current data.

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. Patients should be instructed to stop using the medication 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. It is important to communicate that a persistent cough may indicate a serious underlying condition that requires medical evaluation.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be informed to consult a doctor if their cough is accompanied by excessive phlegm (mucus), if they have diabetes, or if they are currently taking any other medications. This information is crucial for ensuring safe and effective use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its stability. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential misuse or degradation.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients not to use this product if they are pregnant, attempting to become pregnant, or breastfeeding. Patients should consult a doctor prior to use if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, if their cough is accompanied by excessive phlegm, or if they have diabetes or are taking other medications. Patients are also instructed to discontinue use and seek medical advice if their cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache.

Drug Information (PDF)

This file contains official product information for Muca Clear, 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 Muca Clear, 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.