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Childrens Mucus Cough and Congestion Relief

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
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
May 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
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
May 10, 2025
Manufacturer
Walgreen Company
Registration number
M012
NDC root
0363-1056
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

Children’s Mucus Cough & Congestion Relief is an oral solution designed for children aged 4 to 11 years. It contains three active ingredients: dextromethorphan HBr (a cough suppressant), guaifenesin (an expectorant that helps break up mucus), and phenylephrine HCl (a nasal decongestant). This combination works to relieve chest congestion, cough, and a stuffy nose by loosening phlegm and thinning bronchial secretions, making coughs more productive and helping to ease the discomfort associated with colds.

The product temporarily alleviates cough caused by minor throat and bronchial irritation, as well as nasal congestion due to colds. It also helps reduce the intensity of coughing and the impulse to cough, which can assist children in getting a better night's sleep. Available in a pleasant berry flavor, this solution aims to provide relief for common cold symptoms in young children.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive.

You can also use this medication to temporarily relieve symptoms such as cough caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It can help with a stuffy nose and nasal congestion due to a cold, reduce the intensity of your cough, and lessen the urge to cough, making it easier for your child to sleep.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure safety and effectiveness. You should never take more than the directed amount, and make sure not to exceed 6 doses within a 24-hour period. Always use the dose cup that comes with the medication for accurate measurement.

For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours. If your child is between 4 and under 6 years old, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, you should not use this medication. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

What to Avoid

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

It's also important not to exceed the recommended dosage, as doing so can lead to potential risks. Always prioritize safety and seek guidance if you have any questions about the medications your child is taking.

Side Effects

You should be aware of some potential side effects when using this medication. If you experience nervousness, dizziness, or sleeplessness, it's important to stop using the medication and consult a doctor. Additionally, if your symptoms do not improve within 7 days, or if you develop a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice as these could indicate a more serious condition.

It's crucial not to use this medication in children who are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping them. Before using this medication, consult a doctor if the child has diabetes, heart disease, thyroid disease, high blood pressure, or a chronic cough, especially if it involves excessive mucus. In case of an overdose, seek immediate medical help or contact a Poison Control Center.

Warnings and Precautions

It's important to be cautious when using this medication, especially for children. Do not give it to a child who is currently taking a monoamine oxidase inhibitor (MAOI) for depression or other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

Before using this product, check with a doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, or a chronic cough, such as asthma. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days, stop using the medication and contact a doctor. Additionally, if a cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice, as these may indicate a more serious issue. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Your health and safety are the top priority.

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. There may be potential risks to your fetus, so you should approach its use with caution. Always consult your doctor before using this product to ensure it is safe for you and your baby.

There are no specific dosage modifications for pregnant individuals, so it's crucial to seek guidance from a healthcare professional regarding its use. Discussing your situation with your healthcare provider will help you make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using it, consult your doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a chronic cough (like asthma), or a cough with excessive mucus.

For dosing, children aged 6 to under 12 years can take 10 mL every 4 hours, while those aged 4 to under 6 years should take 5 mL every 4 hours. It's crucial not to exceed these recommended doses. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within 7 days, you should stop using the medication and consult a doctor. Additionally, if a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 be cautious when giving medications to children, especially if they are taking certain prescription drugs. Specifically, you should not use this medication in a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's prescription includes an MAOI, it's best to consult with a doctor or pharmacist for guidance.

Always discuss any medications or treatments with your healthcare provider to ensure safety and avoid potential interactions. Your provider can help you understand the risks and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F) occasionally. Always check the end flap of the packaging for the expiration date and lot number, as this information is important for safety and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling will help you use the product safely and effectively.

Additional Information

You should be aware that this medication is taken orally. If you are a parent, it's important to educate yourself about the potential for medicine abuse among teenagers. You can find helpful resources at www.StopMedicineAbuse.org to learn more about this issue and how to prevent it.

FAQ

What is Children's Mucus Cough & Congestion Relief?

Children's Mucus Cough & Congestion Relief is an oral solution that contains DEXTROMETHORPHAN HBr (cough suppressant), GUAIFENESIN (expectorant), and PHENYLEPHRINE HCl (nasal decongestant) to relieve chest congestion, cough, and stuffy nose.

What age group is this medication intended for?

This medication is intended for children aged 4 to 11 years.

How does this medication work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough, stuffy nose, and nasal congestion.

What are the recommended dosages for this medication?

For children 6 to under 12 years, the dose is 10 mL every 4 hours; for children 4 to under 6 years, it's 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this medication?

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

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days.

Is this medication safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a healthcare provider if pregnant or planning to become pregnant.

What should I do in case of an overdose?

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

How should this medication be stored?

Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

Packaging Info

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

Packaging configurations for Childrens Mucus Cough and Congestion Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation contains Dextromethorphan Hydrobromide, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine Hydrochloride, a nasal decongestant. It is presented as an oral solution with a berry flavor. The total volume of the solution is 6.8 fluid ounces (201 mL).

Uses and Indications

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

Additionally, this drug temporarily alleviates symptoms such as a stuffy nose and nasal congestion resulting from a cold. It may also reduce the intensity of coughing and the impulse to cough, aiding children in achieving restful sleep.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage. The maximum allowable dosage is 6 doses within a 24-hour period.

The provided dose cup must be utilized for accurate measurement. The dosing recommendations are as follows:

For children aged 6 to under 12 years, the recommended dose is 10 mL administered every 4 hours. For children aged 4 to under 6 years, the appropriate dose is 5 mL every 4 hours. It is contraindicated to use this medication in children under 4 years of age.

Healthcare professionals should ensure that caregivers are informed of these guidelines to promote safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Prior to administration, consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription.

Additionally, it is contraindicated to exceed the recommended dosage of this product.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). These conditions may necessitate additional monitoring or alternative treatment strategies.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, further evaluation is warranted. A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and requires prompt medical attention.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. If these symptoms occur, patients are advised to stop use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, patients should seek medical advice. A persistent cough lasting more than 7 days, particularly if it tends to recur or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and should be evaluated by a healthcare provider.

This medication is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks, as this combination may lead to serious interactions. Before use, it is important for caregivers to consult a healthcare professional if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, or a persistent or chronic cough, such as that associated with asthma. Additionally, a cough that produces excessive phlegm (mucus) should also prompt a discussion with a healthcare provider prior to use.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

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, certain psychiatric conditions, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 14 days of discontinuing 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 strongly recommended.

Packaging & NDC

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

Packaging configurations for Childrens Mucus Cough and Congestion Relief.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past 2 weeks. Prior to administration, it is advisable to consult a healthcare professional if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm.

Dosage recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours; for children aged 4 to under 6 years, the dose is 5 mL every 4 hours. The medication is not recommended for children under 4 years of age. It is crucial not to exceed the recommended dosage.

Parents or caregivers should discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

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. It is advisable to monitor these patients closely for any 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, as there may be potential risks to the fetus. Use of this product should be approached with caution, and it is advised that pregnant individuals discuss its use with their healthcare provider. No specific dosage modifications are provided for pregnant individuals; therefore, healthcare professionals should be consulted for guidance regarding appropriate use in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed that if symptoms do not improve within seven days, or if they occur alongside a fever, medical advice should be sought. Persistent cough lasting more than seven days, especially if it recurs or is accompanied by fever, rash, or a persistent headache, may indicate a serious condition and warrants further evaluation.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. 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 to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

Parents are encouraged to educate themselves about the potential for medicine abuse among teenagers, with resources available at www.StopMedicineAbuse.org. The medication is administered orally, and clinicians should ensure that patients understand the importance of adhering to the prescribed route and frequency of administration. No further information is available regarding laboratory tests, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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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.