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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 2015
Label revision date
December 4, 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 2015
Label revision date
December 4, 2025
Manufacturer
Chain Drug Manufacturing Assn
Registration number
M012
NDC root
63868-771
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 Relief is a medication designed to help manage cough and relieve chest congestion in children. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for your child to clear their airways. This product temporarily alleviates cough caused by minor throat and bronchial irritation, which can occur with common colds or from inhaling irritants. Additionally, it helps reduce the urge to cough, allowing your child to rest more comfortably.

This alcohol-free, cherry-flavored medication is formulated to make coughs more productive, helping to clear bothersome mucus from the bronchial passageways. Each dose comes with a dosage cup for easy measurement, ensuring that you can provide the right amount for your child's needs.

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 coughs 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 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, they should receive 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 ensure you are measuring the dose in milliliters (mL) for accuracy.

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 must 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 warnings and potential side effects when using this medication. It is not safe for children who are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping these medications. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this product, talk to a doctor if your child has a cough with excessive mucus or a persistent cough, such as one associated with asthma. You should stop using the medication 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 condition. 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 monoamine oxidase inhibitor (MAOI), which is a type of prescription drug 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 your child's 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 be signs of a more serious condition.

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 consult your doctor before using this medication, as its safety during pregnancy has not been established. There may be potential risks to your fetus that are not clearly defined, so caution is advised.

You should only use this medication if it is clearly needed and after discussing it with your healthcare provider. There are no specific dosage modifications provided for pregnant individuals, but your doctor can help determine the best course of action for your situation.

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.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks, do not use this medication. Before giving it to your child, consult a doctor if they have a cough with excessive mucus or a persistent cough, such as one caused by asthma. If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or ongoing 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 to note that this medication should not be given to children under 4 years old. Always follow these guidelines to ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help assess any individual health needs and determine the best approach for treatment. Always prioritize open communication with your healthcare team to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning optimally.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 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. Doing so can lead to serious interactions, and it’s also important to wait at least two weeks after stopping the MAOI before starting this medication.

Always discuss any medications or tests with your healthcare provider. They can help ensure that you avoid potential risks and that your treatment plan is safe and effective. Your health and safety should always come first, so don’t hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best use of your product, store it at room temperature and avoid refrigerating it, as this can affect its effectiveness. When handling the product, check the tamper-evident seal under the cap; do not use it if the seal is torn or missing, as this indicates that the product may not be safe to use.

A dosing cup is provided to help you measure the correct amount for use. Always follow these guidelines to maintain safety 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 Mucus & Cough Relief used for?

Children's Mucus & Cough Relief controls cough, relieves chest congestion, and breaks up mucus to make coughs more productive.

What are the dosage recommendations for Children's Mucus & Cough Relief?

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's 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 a child who is taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

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

Stop use and ask a doctor if the cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

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

Safety during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

What flavor does Children's Mucus & Cough Relief come in?

It is cherry flavored, making it more palatable for children.

How should I measure the dosage?

Measure only with the dosing cup provided and do not use the dosing cup with other products.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Packaging Info

Below are the non-prescription pack sizes of Childrens Mucus and Cough Relief (guaifenesin and dextromethorphan hydrobromide). 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

No description information is available for the 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 helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, thereby assisting children in achieving restful sleep.

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 dosage using only the dosing cup provided with the medication. The dosing cup should not be used with any other products to ensure accurate measurement.

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. This medication is not recommended for 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), 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

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. 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.

Prior to administration, it is essential to consult a healthcare provider if the child presents with a cough accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in cases of asthma. These conditions may require alternative therapeutic approaches.

If the child's cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, it is imperative to discontinue use and seek medical advice. These symptoms may indicate a more serious underlying condition that necessitates further evaluation.

To ensure safety, this product should be kept out of reach of children. In the event 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 product.

Serious adverse reactions may occur, particularly in patients who are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in such patients and should not be administered for at least 2 weeks after discontinuation of the MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, it is imperative to consult a doctor or pharmacist prior to use.

Patients are advised to seek medical advice before using this product if they experience a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, such as that which occurs with asthma.

Additionally, patients should discontinue use and consult a doctor if a 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 illness.

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

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 Childrens Mucus and Cough Relief (guaifenesin and dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Mucus and 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 discontinuing an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has a cough associated with excessive phlegm (mucus) or a persistent cough, such as that which occurs 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 healthcare provider should be consulted.

Dosing recommendations for pediatric patients are as follows: for children aged 6 years to under 12 years, the dosage is 5 mL to 10 mL every 4 hours; for children aged 4 years to under 6 years, the dosage is 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 medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

Safety during pregnancy has not been established for this medication. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. The potential risks to the fetus are not clearly defined, and caution is advised when considering treatment. There are no specific dosage modifications recommended for pregnant individuals. It is essential to use this medication only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

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 not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 effectively. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible.

Healthcare providers should ensure that they are familiar with the specific symptoms associated with the substance in question, as well as the recommended treatment protocols. This may include supportive care and symptomatic treatment tailored to the patient's needs.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, itching, and swelling. Neurological effects such as dizziness, drowsiness, confusion, and hallucinations have also been noted. Gastrointestinal disturbances, including nausea and vomiting, were reported alongside increased heart rate. Additionally, instances of respiratory depression and seizures have 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 two 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 seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

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

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at room temperature and to avoid refrigeration. The packaging features a tamper-evident design; therefore, it should not be used if the printed inner seal under the cap is torn or missing. Proper handling and storage conditions are crucial to ensure the integrity and safety 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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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.