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Mucosa Guifenesin

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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 2020
Label revision date
October 27, 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 2020
Label revision date
October 27, 2023
Manufacturer
Magno-Humphries, Inc.
Registration number
M012
NDC root
54257-776
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 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 respiratory issues that involve congestion.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. When you have a cough, this can make it more productive, allowing you to clear out bothersome mucus from your bronchial passageways. By doing so, it can help relieve discomfort and improve your overall respiratory function.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take one tablet every four hours as needed while your symptoms last. Make sure to swallow the tablet with a full glass of water. However, it’s important not to take more than six doses in a 24-hour period to avoid any potential risks.

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

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, avoid using this medication for more than 7 days, as prolonged use may not be safe.

By following these guidelines, you can help prevent potential issues and ensure that the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

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 could indicate a serious condition, and you should seek medical attention. It's also important to consult a doctor before using this medication if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus.

In the event of an accidental overdose, please get 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 cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus. While using the product, make sure to follow the recommended dosage and do not use it for more than 7 days.

If you accidentally take too much, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, stop using the product and call your doctor if your cough lasts longer than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

If you suspect an accidental overdose, it’s important 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

It's important to know that this medication 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, but you should not take more than six doses in a 24-hour period. Always make sure to take the tablet with a full glass of water.

To keep your child safe, store this medication out of their reach. If you suspect an accidental overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 before starting the medication. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 may affect you 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 and safety of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). This temperature range helps maintain the integrity of the device and its components.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is one tablet every 4 hours as needed, but do not exceed 6 doses in a 24-hour period. If you are caring for a child under 12 years of age, do not use this medication for them. Always take the tablet with a full glass of water to help with absorption.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive to clear bothersome mucus from the bronchial passageway.

How should adults and children 12 years and older take this drug?

You should take one 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 I accidentally take too much of this drug?

In case of accidental overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

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 before using this drug?

Yes, ask a doctor before use if you have a persistent or chronic cough, such as from smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive phlegm.

What should I do if I am pregnant or breastfeeding?

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

What is the recommended storage condition for this drug?

Store the drug at a controlled room temperature between 15° to 30°C (59° to 86°F).

Packaging Info

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

Packaging configurations for Mucosa Guifenesin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the other side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the relief of cough associated with respiratory conditions characterized by the production of excessive mucus. It helps to loosen phlegm and thin bronchial secretions, thereby facilitating more productive coughs to clear the bronchial passageways of bothersome mucus.

Limitations of Use: This medication is not intended for the treatment of cough due to smoking, asthma, or emphysema. It should be used with caution in patients with a history of respiratory conditions that may be exacerbated by increased mucus production.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take one tablet every 4 hours as needed while symptoms persist. It is important not to exceed 6 doses within a 24-hour period.

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

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following guidelines to ensure safe use:

  • Do not exceed the recommended dosage, as this may lead to adverse effects.

  • Do not use the product for more than 7 days to avoid potential complications associated with prolonged use.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product if they have a persistent or chronic cough, such as that 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 it. Furthermore, the product should not be used for a duration exceeding 7 days to mitigate the risk of adverse effects.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare provider if the 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 more serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important to note that a cough lasting more than 7 days, recurring, or accompanied by fever, rash, or persistent headache may indicate a serious underlying condition and should prompt immediate medical evaluation.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional prior to use. Additionally, a cough accompanied by excessive phlegm (mucus) warrants medical advice before initiating treatment.

In the event of an accidental overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

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 Guifenesin (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucosa Guifenesin.
Details

Pediatric Use

Children under 12 years of age should not use this medication. For adults and pediatric patients aged 12 years and older, the recommended dosage is one tablet every 4 hours with a full glass of water, while symptoms persist. The maximum allowable dosage is 6 tablets in a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an accidental 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 to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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 arise 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 provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an accidental overdose. It is important to inform patients that they should 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, as these may indicate a serious underlying condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. Additionally, patients should be instructed not to use the product for more than 7 days.

Patients should be encouraged to consult with their healthcare provider 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every 4 hours, taken with a full glass of water, while symptoms persist, with a maximum of 6 doses in a 24-hour period. The use of this medication is not recommended for children under 12 years of age.

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

Drug Information (PDF)

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