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Topcare Mucus Er

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Active ingredient
Guaifenesin 1200 mg
Other brand names
Dosage form
Tablet, Multilayer, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
September 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 1200 mg
Other brand names
Dosage form
Tablet, Multilayer, Extended Release
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 2022
Label revision date
September 16, 2024
Manufacturer
Topco Associates LLC
Registration number
ANDA213420
NDC root
76162-523
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Guaifenesin Extended-Release Tablets (1200 mg) are a maximum strength expectorant designed to help you relieve chest congestion. This medication works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier to clear mucus from your airways and making coughs more productive.

These tablets provide both immediate and extended release of the active ingredient, allowing for relief over a 12-hour period. If you're dealing with bothersome mucus, Guaifenesin can help you breathe easier by clearing 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.

You can expect this treatment to assist in clearing your airways, allowing for better airflow and easier breathing.

Dosage and Administration

When taking this medication, it's important to swallow the tablet whole—do not crush, chew, or break it. Make sure to take it with a full glass of water, which helps the tablet dissolve properly. You can take this medication at any time, regardless of your meal schedule.

For adults and children aged 12 years and older, the recommended dose is one tablet every 12 hours. However, be careful not to take more than two tablets in a 24-hour period. If you have children under 12 years of age, this medication is not suitable for them, so please avoid using it for that age group.

What to Avoid

It's important to be aware of specific guidelines when considering this medication. You should not use it for children under 12 years of age, as it may not be safe for them.

Currently, there are no specified contraindications, risks of abuse or misuse, or concerns regarding dependence (which refers to a condition where the body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. Before using it, consult your doctor if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and seek medical advice, as these symptoms may indicate a more serious condition.

Warnings and Precautions

You should not use this medication if you are under 12 years old. Before using it, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces a lot of mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop taking the medication and contact your doctor, as these may indicate a more serious condition. In the event of an overdose, seek emergency medical help immediately or call the Poison Control Center at 1-800-222-1222.

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.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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

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 aged 12 and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets in a 24-hour period.

If your child is under 12 and has a persistent or chronic cough—especially if it’s related to smoking, asthma, chronic bronchitis, or emphysema, or if it comes with excessive mucus, lasts more than seven days, or is accompanied by fever, rash, or a persistent headache—you should consult a doctor for evaluation.

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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare provider for personalized advice, as they can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with medical professionals to ensure safe and effective use of any medication.

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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness and safety.

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

No further information is available.

FAQ

What is Guaifenesin Extended-Release Tablets used for?

Guaifenesin Extended-Release Tablets help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

How should I take Guaifenesin Extended-Release Tablets?

You should take 1 tablet every 12 hours with a full glass of water, and do not exceed 2 tablets in 24 hours.

Who should not use Guaifenesin Extended-Release Tablets?

Do not use this product for children under 12 years of age.

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

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, stop use and ask a doctor.

Are there any teratogenic effects associated with Guaifenesin?

No teratogenic effects are mentioned for Guaifenesin Extended-Release Tablets.

Can I take Guaifenesin Extended-Release Tablets if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Topcare Mucus Er.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Guaifenesin Extended-Release Tablets contain 1200 mg of guaifenesin, an expectorant designed for both immediate and extended release. Each bottle contains 14 extended-release tablets, formulated to facilitate the effective management of symptoms associated with respiratory conditions.

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

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended that the tablet be ingested with a full glass of water. This medication can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours. The maximum allowable dosage is 2 tablets within a 24-hour period.

This medication is not indicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age due to safety concerns associated with this population. No other contraindications have been specified.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age.

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

Patients must be instructed to discontinue use and contact their healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of overdose situations.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated for children under 12 years of age. Prior to use, patients are advised to consult a healthcare professional if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Patients should discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms 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 with 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 Topcare Mucus Er (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topcare Mucus Er.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

In children under 12 years, persistent or chronic coughs—such as those associated with smoking, asthma, chronic bronchitis, or emphysema—should be evaluated by a healthcare professional. Additionally, coughs accompanied by excessive phlegm, lasting more than 7 days, or associated with fever, rash, or persistent headache warrant medical assessment.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 regarding 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 these patients to ensure safety and efficacy.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous assessment and monitoring of vital signs are recommended to ensure patient safety and to guide further therapeutic interventions.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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 at 1-800-222-1222 in the event of an overdose. It is important to inform patients that this medication is not recommended for use in children under 12 years of age.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, 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 persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also 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 temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Topcare Mucus Er, 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 Topcare Mucus Er, 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.