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Mucosa

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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 2012
Label revision date
November 2, 2023
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 2012
Label revision date
November 2, 2023
Manufacturer
TIME CAP LABORATORIES, INC
Registration number
M012
NDC root
49483-272
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

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear bothersome mucus from your bronchial passageways. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes your coughs more productive, allowing you to clear out bothersome mucus from your bronchial passageways. This can be particularly helpful if you're dealing with congestion or respiratory issues.

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

If you are an adult or a child aged 12 years and older, you can take 1 tablet every 4 hours as needed while your symptoms last. It's important to drink a full glass of water with each tablet to help it work effectively. However, make sure not to take more than 6 tablets in a 24-hour period to avoid any potential side effects.

If your child is under 12 years old, you should not use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, it's advised not to use this medication for more than 7 days. Following these guidelines will help you avoid potential risks and ensure the medication works effectively for you.

Side Effects

If you experience a cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these could indicate a serious condition. Additionally, you should talk to your doctor before using this medication if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough comes with excessive phlegm (mucus), seek medical advice.

While using this product, make sure to follow the recommended dosage and do not use it for more than 7 days. If your cough lasts longer than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these symptoms may indicate a more serious condition.

In the event of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your health and safety are important, so please take these precautions seriously.

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.

Don’t wait to see if symptoms improve; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help as soon as you notice any concerning symptoms.

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 professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your healthcare professional before using any medication. They can provide guidance on the safety and potential effects on you and your baby. Always prioritize open communication with your doctor to ensure the best care for both you and your child.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years of age. For those who are 12 years and older, the recommended dosage is one tablet every four hours as needed, accompanied by a full glass of water. However, be cautious not to exceed six doses within a 24-hour period. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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 wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action, considering any unique health needs or conditions that may be present.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 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 of 25°C (77°F). It can safely be kept in a range between 15°C and 30°C (59°F to 86°F), but try to avoid exposing it to excessive heat. Make sure to keep it in a dry place to maintain its quality.

When handling the product, always do so with care to prevent any damage. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

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, accompanied by a full glass of water. However, do not exceed 6 doses within a 24-hour period. If you are caring for a child under 12 years old, do not use this medication for them.

FAQ

What is the main use of this drug?

This drug helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive, aiding in the removal of bothersome mucus from the bronchial passageway.

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

You should take 1 tablet every 4 hours with a full glass of water while symptoms persist, but do not exceed 6 doses in 24 hours.

Can children under 12 years of age use this drug?

No, this drug should not be used by children under 12 years of age.

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

You should stop using the drug and ask a doctor if your cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Are there any warnings I should be aware of?

Yes, 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 at 1-800-222-1222 right away.

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a healthcare professional before using this drug.

How should I store this drug?

Store the drug at 25°C (77°F), with excursions permitted between 15°-30°C (59°-86°F), and keep it in a dry place away from excessive heat.

Packaging Info

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

Packaging configurations for Mucosa.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3 in the provided text.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing productive coughs associated with respiratory conditions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the effectiveness of coughs to expel bothersome mucus from the bronchial passageway.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours as needed while symptoms persist. It is essential to administer the tablet with a full glass of water. The maximum allowable dosage is 6 tablets within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or use it for more than 7 days. Adherence to these guidelines is essential to prevent potential adverse effects associated with prolonged use or excessive dosing.

Warnings and Precautions

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

When utilizing this product, it is imperative to adhere to the recommended dosage and not to exceed the specified duration of use, which should not exceed 7 days. Prolonged use beyond this timeframe may pose risks to the patient’s health.

Patients are advised to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt action is essential to ensure patient safety in such situations.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to stop 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 could indicate a serious underlying condition.

Before using this medication, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, a cough accompanied by excessive phlegm (mucus) warrants consultation with a healthcare provider prior to use.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Mucosa.
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 full glass of water, as needed while symptoms persist. It is important not to exceed 6 doses in a 24-hour period.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare 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

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 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 or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition. It is important to emphasize that patients should not exceed the recommended dosage while using this product and should not use it for more than 7 days.

Additionally, healthcare providers should encourage patients to consult a doctor before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 and 86°F).

It is essential to keep the product in a dry place and to avoid exposure to excessive heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for ensuring the product's quality throughout its shelf life.

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, not to exceed six doses within a 24-hour period. The use of this medication is not recommended for children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mucosa, 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 Mucosa, 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.