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Cvs Childrens 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 2022
Label revision date
December 10, 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 2022
Label revision date
December 10, 2025
Manufacturer
CVS PHARMACY, INC
Registration number
M012
NDC root
69842-577
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 Relief is a medication designed to help alleviate cough and chest congestion in children aged 4 years and older. It contains two active ingredients: dextromethorphan HBr, which helps reduce the urge to cough, and guaifenesin, which works to loosen phlegm (mucus) and thin bronchial secretions. This combination makes coughs more productive by clearing mucus from the bronchial passageways, providing relief from minor throat and bronchial irritation often associated with the common cold or inhaled irritants.

In addition to controlling cough, Children's Cough Relief can help children sleep better by reducing the intensity of coughing. The product is available in a pleasant natural cherry flavor and comes with a dosage cup for easy measurement.

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 airways, making your coughs more productive.

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

Dosage and Administration

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

For children, the dosage varies by age. If your child is between 6 years and under 12 years, they can take between 5 mL and 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. However, if your child is under 4 years old, this medication should not be used. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific medications used 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, please consult with a doctor or pharmacist for guidance.

Using this medication inappropriately can lead to serious health risks, so always follow these instructions carefully to ensure your child's safety.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. It is not safe to use if your child is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or for two weeks after stopping an MAOI.

If your child has a cough that produces a lot of mucus or a persistent cough, such as one related to asthma, consult a doctor before using this medication. You should also stop using it and seek medical advice if the cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious issue. In case of an overdose, it’s crucial to get medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not give this medication to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain 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 administering this product.

Before using this medication, it's important to ask a doctor if your child has a cough that produces a lot of mucus or a persistent cough, such as one associated with asthma. If the cough lasts more than seven days, returns, or is accompanied by a fever, rash, or ongoing headache, stop using the medication and contact a doctor, as these may indicate a more serious issue.

Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

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

Pregnancy Use

If you are pregnant or 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, and further studies are needed to fully understand these risks. Therefore, it is crucial to consult your doctor before using this product.

Currently, there are no specific dosage modifications recommended for pregnant individuals, so it's best to seek guidance from a healthcare professional regarding its use. Your health and the health of your baby are the top priority, so always discuss any medications or treatments with your doctor.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

You should avoid giving this medication to your child if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or if they have stopped taking it within the last two weeks. Before using the medication, consult your doctor if your child has a cough that produces a lot of mucus or if they have a persistent cough, such as one associated with asthma.

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. It is important not to use this medication in children under 4 years old.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with their doctor about any potential risks or adjustments in dosage that may be necessary. Always ensure that their healthcare team is aware of any other medications they are taking, as this can help prevent interactions and ensure safe use.

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, especially if you have any concerns about your kidney health. They can provide the necessary guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be cautious when it comes to medications, especially if you or your child are taking certain drugs. For instance, if your child is on a prescription monoamine oxidase inhibitor (MAOI), a type of medication used to treat depression, you should avoid using this drug while they are taking the MAOI and for at least two weeks after stopping it. This is crucial because combining these medications can lead to serious interactions that may affect your child's health.

Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness. They can help you understand potential risks and make informed decisions about treatment options.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important not to refrigerate it, as this can affect its effectiveness. Before using, check the tamper-evident seal under the cap; do not use the product if this seal is torn or missing, as it indicates that the product may have been compromised. Following these guidelines will help you use the product safely and effectively.

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 Relief?

Children's Cough Relief is a cough medication that contains Dextromethorphan HBr and Guaifenesin, designed to control cough and relieve chest congestion.

What age group is Children's Cough Relief suitable for?

This product is suitable for children aged 4 years and older.

How does Children's Cough Relief work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough due to throat and bronchial irritation.

What is the recommended dosage for children?

For children 6 years to under 12 years, the dosage is 5 mL – 10 mL every 4 hours. For children 4 years to under 6 years, it is 2.5 mL – 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this product?

Do not use 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?

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

Is it safe to use Children's Cough Relief during pregnancy?

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

Can nursing mothers use Children's Cough Relief?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

What should I do in case of an overdose?

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

How should Children's Cough Relief be stored?

Store at room temperature and do not refrigerate. Ensure the inner seal under the cap is intact before use.

Packaging Info

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

Packaging configurations for Cvs Childrens Cough Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which can assist children in achieving restful sleep.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided, and this cup should not be used with any other products to ensure accurate dosing.

For children aged 6 years to under 12 years, the recommended dose is 5 mL to 10 mL administered every 4 hours as needed. For children aged 4 years to under 6 years, the appropriate dose is 2.5 mL to 5 mL every 4 hours as needed. It is important to note that this product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise caregivers to adhere strictly to these dosing guidelines or to follow any specific instructions provided by a physician.

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, use is contraindicated 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 administration 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 an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to administration of this product.

Healthcare professionals should advise caregivers to seek medical guidance before using this product if the child presents with a cough that is accompanied by excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that associated with asthma.

In the event that the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, caregivers should discontinue use and consult a healthcare provider. These symptoms may indicate a serious underlying condition that requires further evaluation.

It is essential to keep this product out of the reach of children. In the case of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication.

Warnings: The medication is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for a period of 2 weeks following the discontinuation of an MAOI. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease.

Precautions: Prior to use, it is advisable to consult a healthcare professional if the child has a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur with asthma.

Discontinuation Advice: Patients should discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Overdose Information: In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

These considerations are essential for ensuring the safe use of the medication and for recognizing potential serious adverse reactions.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary beyond the specified contraindication with MAOIs.

Packaging & NDC

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

Packaging configurations for Cvs Childrens Cough Relief.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has a cough accompanied by excessive phlegm (mucus) or a persistent cough, such as that associated with asthma.

If the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, the use of this medication should be discontinued, and a doctor should be consulted.

Dosing recommendations are as follows:

  • For children aged 6 years to under 12 years: 5 mL to 10 mL every 4 hours.

  • For children aged 4 years to under 6 years: 2.5 mL to 5 mL every 4 hours.

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

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

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. Further studies are needed to determine the safety profile of this product in pregnant individuals. Currently, no specific dosage modifications for pregnant individuals are provided; therefore, it is essential for healthcare professionals to offer guidance based on individual circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at 1-800-222-1222.

Prompt intervention is crucial in managing overdose situations. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise. It is essential to monitor the patient closely and provide supportive care as needed.

Management procedures should include a thorough evaluation of the patient's condition, including vital signs and any presenting symptoms. Depending on the severity of the overdose, treatment may involve decontamination, administration of antidotes, or other supportive measures as deemed appropriate by medical professionals.

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 associated with the product, reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, increased heart rate, and respiratory depression have also been documented.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 2 weeks of stopping such a 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 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

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

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence. It is essential to inspect the printed inner seal under the cap; the product should not be used if this seal is torn or missing.

For optimal storage, the product must be kept at room temperature. It is important to avoid refrigeration, as this may compromise the integrity 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 Cvs Childrens 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 Cvs Childrens 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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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.