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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 2025
Label revision date
January 29, 2025
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 2025
Label revision date
January 29, 2025
Manufacturer
CVS
Registration number
M012
NDC root
51316-552
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 Cough is a medication designed to help relieve cough and chest congestion in children aged 4 years and older. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to help control the urge to cough, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination works to make coughs more productive by breaking up mucus and relieving chest congestion, making it easier for your child to breathe and sleep.

This medication is free of alcohol, parabens, and high fructose corn syrup, and it comes in a pleasant natural cherry flavor. It is formulated to temporarily relieve cough caused by minor throat and bronchial irritation, such as that which may occur with a cold or from inhaled irritants.

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 lead to more productive coughs.

It also provides temporary relief from coughing caused by minor throat and bronchial irritation, which can happen due to a cold or when you inhale irritants. If your child is having trouble sleeping because of a cough, this medication can help reduce the urge to cough, allowing for a more restful night. Additionally, it can lessen the intensity of coughing, making it more manageable.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully to ensure safety and effectiveness. For children aged 6 years to under 12 years, you should give a dose of 5 mL to 10 mL every 4 hours. For younger children, specifically those aged 4 years to under 6 years, the recommended dose is 2.5 mL to 5 mL, also every 4 hours.

If your child is under 4 years old, do not use this medication. Remember to measure the doses using only the dosing cup provided with the medication, as using a different cup can lead to incorrect dosing. Additionally, make sure not to exceed 6 doses in any 24-hour period to avoid potential overdose.

What to Avoid

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

Taking these precautions is crucial to prevent potential harmful interactions and ensure your child's safety. Always prioritize open communication with healthcare professionals regarding any medications your child is taking.

Side Effects

If you experience a cough that lasts more than 7 days, returns after improvement, or is accompanied by fever, rash, or a persistent headache, it’s important to seek medical attention, as these could be signs of a serious illness.

Before using this medication, consult your doctor if your child has a persistent or chronic cough, such as one associated with asthma, or if the cough is accompanied by excessive phlegm (mucus).

Warnings and Precautions

If you experience an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this medication and call your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

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 have concerns about an overdose, 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 assistance if you think something is wrong.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this product during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Before using this product, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

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

You should not give this medication to your child if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or if they have stopped taking one within the last two weeks. Before using this medication, consult your doctor if your child has a persistent or chronic cough, such as one caused by asthma, or if the cough is accompanied by excessive mucus.

If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the medication and seek medical advice. For dosing, children aged 6 to under 12 years can take 5 mL to 10 mL every four hours, while those aged 4 to under 6 years should take 2.5 mL to 5 mL every four hours. This medication is not recommended for children under 4 years old.

Geriatric Use

When it comes to using this medication in older adults, there are no specific recommendations or precautions outlined. This means that, generally, the same guidelines apply to you as they do to younger adults. However, it's always important to consult with your healthcare provider about any concerns or questions you may have, especially regarding your overall health and any other medications you may be taking. Your doctor can help ensure that this treatment is safe and effective for your individual needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Regular monitoring of your renal function is essential, and this typically involves tests that measure creatinine clearance (a way to assess kidney function).

Before starting any new treatment, your healthcare provider will likely recommend renal function tests, and these should be repeated periodically to ensure your safety. If you have severe renal impairment, special care will be taken to adjust your dosage appropriately. Always communicate with your healthcare team about your kidney health to ensure the best possible care.

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 crucial to be aware of potential interactions when considering medications for yourself or your child. Specifically, 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, certain psychiatric conditions, or Parkinson's disease. 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 healthcare provider or pharmacist for clarification.

Always discuss any medications or treatments with your healthcare provider to ensure safety and effectiveness, especially when it comes to interactions that could affect 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 Children's Cough used for?

Children's Cough helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It temporarily relieves cough due to minor throat and bronchial irritation, helping your child get to sleep.

What are the active ingredients in Children's Cough?

Children's Cough contains Dextromethorphan HBr 5mg, a cough suppressant, and Guaifenesin 100 mg, an expectorant.

What is the recommended dosage for children aged 6 to under 12 years?

For children aged 6 to under 12 years, the recommended dose is 5 mL to 10 mL every 4 hours, not exceeding 6 doses in 24 hours.

Can I give Children's Cough to a child under 4 years old?

No, Children's Cough should not be used in children under 4 years of age.

Are there any contraindications for using Children's Cough?

Do not use Children's Cough in a child who is 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?

If your child's cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, stop use and consult a doctor.

Is Children's Cough safe during pregnancy or for nursing mothers?

The insert does not provide specific information regarding the use of Children's Cough during pregnancy or while nursing.

What are the storage instructions for Children's Cough?

Store Children's Cough between 20 to 25°C (68 to 77°F) and do not refrigerate.

What flavor does Children's Cough have?

Children's Cough has a natural cherry flavor.

What should I do in case of an overdose?

In case of overdose, get 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

CVS Health Children's Cough is a liquid formulation designed for the relief of cough and chest congestion in children aged 4 years and older. Each 4 FL OZ (118 mL) bottle contains Dextromethorphan HBr 5 mg, a cough suppressant, and Guaifenesin 100 mg, an expectorant that aids in breaking up mucus. The product is free of alcohol, parabens, and high fructose corn syrup, and features a natural cherry flavor for palatability. A dosage cup is included for accurate measurement. The National Drug Code (NDC) for this product is 51316-552-03.

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 the drainage of bronchial tubes and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the impulse to cough, which may assist children in achieving 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.

The maximum allowable dosage is 6 doses within any 24-hour period. It is imperative to measure the medication using only the dosing cup provided with the product. The dosing cup should not be used for any other products to ensure accurate dosing.

For children aged 6 years to under 12 years, the recommended dose is between 5 mL and 10 mL, administered every 4 hours as needed. For children aged 4 years to under 6 years, the appropriate dose ranges from 2.5 mL to 5 mL, also given every 4 hours as necessary.

This medication is not recommended for use in children under 4 years of age.

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 cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying illness.

Additionally, it is advised that patients consult a healthcare professional before using this medication if the child has a persistent or chronic cough, such as that which occurs with asthma, or if the cough is associated with excessive phlegm (mucus). These considerations are important to ensure the safe and effective use of the medication.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. Specifically, it should not be administered to children who are currently taking a prescription MAOI, which includes certain medications prescribed for depression, psychiatric disorders, emotional conditions, or Parkinson's disease. Additionally, this product should not be used for a period of 2 weeks following the discontinuation of an MAOI.

Healthcare professionals are advised to confirm whether a child's prescription medication contains an MAOI prior to the administration of this product. If there is any uncertainty, consultation with a doctor 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 6 years to under 12 years may be administered a dose of 5 mL to 10 mL every 4 hours. For children aged 4 years to under 6 years, the recommended dose is 2.5 mL to 5 mL every 4 hours. Use is not recommended in children under 4 years of age.

Caution is advised when considering use in pediatric patients who are taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks. Parents or caregivers should consult a healthcare professional before use 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).

If the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, parents or caregivers should discontinue use and seek medical advice.

Geriatric Use

Elderly patients may not require specific recommendations or precautions based on the available data. However, healthcare providers should remain vigilant when prescribing to this population, considering the potential for altered pharmacokinetics and increased sensitivity to medications. Regular monitoring and assessment of therapeutic response and adverse effects are advisable to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative therapies may be warranted based on individual patient circumstances. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

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 may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, ensuring that appropriate modifications are made to optimize therapeutic outcomes. Special consideration is warranted for patients with severe renal impairment, as they may require more stringent monitoring and adjustments. Renal function tests are recommended prior to initiating therapy and should be conducted periodically thereafter to assess any changes in renal status.

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 in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for potential overdosage scenarios.

Recommended Actions

In the event of suspected overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms

While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures

Healthcare providers should follow standard protocols for managing drug overdosage, which may include activated charcoal administration if the patient presents within a suitable timeframe. Additionally, consultation with a poison control center or toxicology expert is recommended to guide further management and treatment options.

In summary, due to the absence of detailed overdosage information, healthcare professionals must rely on their clinical judgment and established guidelines for the management of potential overdosage cases.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, gastrointestinal disturbances have been noted, including nausea and vomiting. Central nervous system effects, specifically dizziness and drowsiness, have also been reported.

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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be administered for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and consult a doctor if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious condition.

Furthermore, 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 with a dosing cup included for accurate measurement. It should be stored at a temperature range of 20 to 25°C (68 to 77°F). It is important to note that refrigeration is not permitted for this product. Proper storage conditions must be maintained to ensure 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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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.