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Leader Chest Congestion 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 2020
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 2020
Label revision date
December 18, 2024
Manufacturer
Cardinal Health
Registration number
M012
NDC root
70000-0055
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. 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. 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 aged 6 to 10 years, 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 this 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 the guidance provided by your healthcare professional for the best results.

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 mentioned, 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 is related to smoking, asthma, bronchitis, or emphysema. Additionally, if your cough is accompanied by 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. It's also crucial to stop use if your cough lasts more than a week or keeps coming back, as this could indicate a more serious health issue.

Warnings and Precautions

Before using this medication, it's important to consult your doctor 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 phlegm (mucus), you should also seek medical advice.

To ensure safety, keep this medication out of reach of children. If you suspect an overdose, seek medical help or contact a Poison Control Center right away. You should stop taking the medication and call your doctor if you experience symptoms like fever, rash, or a persistent headache. Also, if your cough lasts more than a week or keeps coming back, it's crucial to consult your doctor, as this could indicate a more serious health issue.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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

When giving this medication to children, it's important to follow specific guidelines based on their age. For children aged 12 and older, you can administer 1 tablet every 4 hours as needed. If your child is between 6 and 10 years old, the recommended dose is 1/2 tablet every 4 hours. For children under 6 years of age, you should consult a doctor before giving them this medication.

Always remember not to exceed 6 doses in a 24-hour period, unless directed otherwise by a healthcare professional. Keeping these guidelines in mind will help ensure the safe use of the medication for your child.

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 professional for personalized advice. They can help determine the best approach to using this medication safely and effectively, considering any unique health needs or conditions that may be present.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance 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 product's effectiveness and safety.

When handling the product, be sure to do so with clean hands or gloves to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

For adults and children aged 12 and over, you should take 1 tablet every 4 hours as needed. If your child is between 6 to 10 years old, give them 1/2 tablet every 4 hours as needed. For children under 6 years of age, it's important to consult a doctor before administering any medication. Remember not to exceed 6 doses in a 24-hour period unless directed by a healthcare professional.

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.

What is the dosage for children aged 6 to 10?

Children aged 6 to 10 should take 1/2 tablet every 4 hours as needed.

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

Consult a doctor before giving this drug to children under 6 years of age.

Are there any contraindications for this drug?

No specific contraindications are mentioned in the provided information.

What should I do if my symptoms are accompanied by fever or rash?

Stop use and ask your doctor if symptoms are accompanied by fever, rash, or a persistent headache.

Can I take this drug if I am pregnant or breastfeeding?

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

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

What is the maximum dosage allowed in a 24-hour period?

Do not exceed 6 doses in a 24-hour period or as directed by a doctor.

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

Stop use and ask your doctor if your cough persists for more than 1 week or tends to recur.

Packaging Info

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

Packaging configurations for Leader Chest Congestion Relief.
Details

Drug Information (PDF)

This file contains official product information for Leader Chest Congestion Relief, 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 SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 aged 12 years and older 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 within a 24-hour period, unless otherwise directed by a physician. Proper adherence to these guidelines is crucial for safe and effective use of the medication.

Contraindications

There are no specific contraindications identified 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, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought.

It is essential to keep this medication out of the reach of children. In the event of an overdose, immediate medical assistance should be obtained, or contact a Poison Control Center without delay.

Patients are advised to discontinue use and contact 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 a serious underlying 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, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought.

In the event that symptoms are accompanied by fever, rash, or a persistent headache, patients are instructed to discontinue use and consult a doctor. Furthermore, if a cough persists for more than one week or tends to recur, it is essential to seek medical attention, 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 Leader Chest Congestion Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Chest Congestion 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 healthcare professional. 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.

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

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 on 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent, provided there are no contraindications.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the medication and consult their doctor if they experience symptoms accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, patients should be encouraged to seek medical advice, as a persistent cough may indicate a serious underlying condition.

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 integrity and efficacy. 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 Leader Chest Congestion 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 Leader Chest Congestion 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.