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Childrens Mucus and Cough Relief

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2023
Label revision date
December 16, 2024
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Registration number
M012
NDC root
70000-0630
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

LEADER is a children's medication designed to provide relief from cough and mucus congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to help reduce the urge to cough, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination makes it easier for your child to cough up mucus, leading to more productive coughing and relief from chest congestion.

LEADER is intended for children aged 4 years and older and can temporarily relieve cough caused by minor throat and bronchial irritation, such as that which may occur with a cold or from inhaled irritants. Additionally, it can help your child get to sleep by reducing the intensity of coughing. The medication is cherry-flavored, making it more palatable for children.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This makes it easier for your body to drain the bronchial tubes and can help make your coughs more productive.

You can use this medication to temporarily relieve coughing caused by minor throat and bronchial irritation, which can happen with a cold or from inhaling irritants. It can also help reduce the urge to cough, making it easier for your child to fall asleep, and lessen the intensity of coughing.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully to ensure safety and effectiveness. You should never take more than 6 doses within a 24-hour period. To measure your dose accurately, use only the dosing cup that comes with the medication, and avoid using it with any other products.

For children aged 6 years to under 12 years, the recommended dose is between 5 mL and 10 mL every 4 hours. If your child is between 4 years and under 6 years, the dose should be between 2.5 mL and 5 mL every 4 hours. Please note that this medication is not suitable for children under 4 years of age, so do not use it for them. Always ensure you are measuring the dose in milliliters (mL) as indicated.

What to Avoid

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific drugs used for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, do not use this medication for at least 2 weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, it's important to consult with a doctor or pharmacist before administering this product.

Be mindful that misuse or abuse of this medication can lead to dependence (a condition where the body becomes reliant on a substance). Always follow these guidelines to ensure safety and effectiveness.

Side Effects

If you experience a cough that lasts more than 7 days, returns after disappearing, or is accompanied by symptoms like fever, rash, or a persistent headache, it could indicate a serious illness, and you should seek medical attention.

Additionally, be aware that a persistent or chronic cough, such as that associated with asthma, or a cough that produces excessive phlegm (mucus), may also occur. It's important to monitor these symptoms and consult with your healthcare provider if they arise.

Warnings and Precautions

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it’s important to stop using the medication and contact your doctor. These symptoms could indicate a more serious health issue that needs attention.

In the event of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so don’t hesitate to reach out for assistance if you find yourself in this situation.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate an overdose, such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus, and further studies are needed to fully understand these risks.

If your doctor determines that you need to use this product, it should only be used if the benefits clearly outweigh any potential risks to your baby. There are no specific dosage modifications provided for pregnant individuals, so it's essential to follow your healthcare provider's guidance closely.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If your child has a persistent or chronic cough, such as one caused by asthma, or a cough with excessive mucus, it's important to consult a doctor before using this medication.

For dosing, children aged 6 years to under 12 years can take 5 mL to 10 mL every 4 hours, while those aged 4 years to under 6 years should take 2.5 mL to 5 mL every 4 hours. This medication is not recommended for children under 4 years old. Always follow these guidelines to ensure your child's safety and well-being.

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 considering this medication, it’s important to consult with a healthcare provider. 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 your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, special monitoring will be required to manage your treatment effectively. Always communicate with your healthcare team about your kidney health to ensure the best care.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's crucial to be aware of potential interactions when considering medications for yourself or your child. For instance, you should not use this medication if your child is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of prescription drug often used for depression or certain psychiatric conditions. Additionally, you should wait at least two weeks after stopping an MAOI before using this medication. If you're unsure whether your child's prescription includes an MAOI, it's important to consult with a doctor or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure safety and effectiveness. They can help you navigate potential interactions and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 20 to 25°C (68 to 77°F). It's important not to refrigerate the product, as this can affect its effectiveness.

When using the product, a dosing cup is provided to help you measure the correct amount safely. Always handle the product with care to maintain its quality and effectiveness.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is LEADER used for?

LEADER is a children's mucus and cough relief medication that helps loosen phlegm and thin bronchial secretions, making coughs more productive.

What are the active ingredients in LEADER?

LEADER contains Dextromethorphan HBr (5 mg) and Guaifenesin (100 mg).

What age group can use LEADER?

LEADER is intended for children aged 4 years and older.

How should I dose LEADER for my child?

For children 6 years to under 12 years, give 5 mL to 10 mL every 4 hours. For children 4 years to under 6 years, give 2.5 mL to 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using LEADER?

Do not use LEADER in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

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

Stop using LEADER and consult a doctor if the cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

Is LEADER safe to use during pregnancy?

The safety of LEADER during pregnancy has not been established, and it should only be used if clearly needed.

What are the storage instructions for LEADER?

Store LEADER between 20 to 25°C (68 to 77°F) and do not refrigerate.

What should I do in case of an overdose?

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

Packaging Info

Below are the non-prescription pack sizes of Childrens Mucus and Cough Relief (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Mucus and Cough Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Mucus & Cough Relief is a formulation designed for pediatric use, containing active ingredients of Dextromethorphan HBr at a concentration of 5 mg and Guaifenesin at 100 mg. This product serves as both a cough suppressant and an expectorant, effectively controlling cough, relieving chest congestion, and thinning and loosening mucus. It is indicated for children aged 4 years and older and is presented in a 4 FL OZ (118 mL) volume. The product features a cherry flavor and is comparable to Children's Mucinex® Cough.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to colds or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the impulse to cough, which may help children achieve restful sleep, and reduces the intensity of coughing episodes.

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

Dosage and Administration

Healthcare professionals should adhere to the following dosage and administration guidelines when prescribing this medication.

For children aged 6 years to under 12 years, the recommended dosage is 5 mL to 10 mL administered every 4 hours as needed. For children aged 4 years to under 6 years, the dosage is 2.5 mL to 5 mL every 4 hours as needed. It is important to note that this medication should not be used in children under 4 years of age.

Healthcare professionals must ensure that no more than 6 doses are administered within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the medication, and this cup should not be used for measuring other products to ensure accurate dosing.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be administered for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is advised prior to use.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if a 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 the presence of a serious underlying condition that requires further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may include a persistent or chronic cough, which can occur in conditions such as asthma. Additionally, patients experiencing a cough that is accompanied by excessive phlegm (mucus) should seek medical attention, as this may indicate a more serious underlying condition.

It is important for patients to monitor their symptoms closely. If a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, these could be signs of a serious illness requiring immediate medical evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, or Parkinson's disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 14 days following the discontinuation of such therapy.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is recommended to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Mucus and Cough Relief (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Mucus and Cough Relief.
Details

Pediatric Use

Pediatric patients aged 4 years and older may use this medication; however, it is contraindicated in children under 4 years of age. For children aged 6 years to under 12 years, the recommended dosage is 5 mL to 10 mL every 4 hours. For those aged 4 years to under 6 years, the dosage is 2.5 mL to 5 mL every 4 hours.

It is critical to avoid use in any child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken an MAOI within the past 2 weeks. Additionally, caregivers should consult a healthcare professional before administering this medication if the child has a persistent or chronic cough, such as that associated with asthma, or if the cough is accompanied by excessive phlegm (mucus).

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. There may be potential risks to the fetus, and further studies are needed to determine the safety profile of this product in pregnant individuals.

No specific dosage modifications are provided for pregnant individuals. It is recommended that this product be used during pregnancy only if clearly needed, and when the potential benefits justify the potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Although no specific symptoms are documented, vigilance is essential, as the clinical presentation may vary based on individual patient factors and the context of the overdose.

In the event of suspected overdosage, it is recommended that healthcare professionals initiate supportive care. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety. Consultation with a poison control center or a medical toxicologist may also be beneficial for guidance on management strategies tailored to the specific situation.

Given the lack of detailed information, it is crucial for healthcare providers to remain alert and prepared to address any complications that may arise from an overdose, while also documenting the incident thoroughly for future reference.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include anaphylaxis, skin reactions, and respiratory reactions.

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 crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious condition.

Additionally, healthcare providers should recommend that patients seek medical advice before using this medication if the child has a persistent or chronic cough, such as that associated with asthma, or if the cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Mucus and Cough 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 Childrens Mucus and Cough 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.

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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.