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Childrens Mucus Relief Cough

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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 16, 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 16, 2025
Manufacturer
Topco Associates
Registration number
M012
NDC root
76162-294
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 Mucus Relief is a medication designed for children aged 4 to 11 years, containing Dextromethorphan HBr (5 mg), which acts as a cough suppressant, and Guaifenesin (100 mg), an expectorant. This alcohol-free syrup has a pleasant cherry flavor and comes with a dosing cup for easy administration.

This product helps to loosen phlegm (mucus) and thin bronchial secretions, making it easier for your child to cough up bothersome mucus. It temporarily relieves cough caused by minor throat and bronchial irritation, which can occur with common colds or inhaled irritants, and can also help reduce the urge to cough, allowing your child to sleep more comfortably.

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 instructions carefully to ensure safety and effectiveness. First, make sure to shake the bottle well before each use. You should only measure the medication using the dosing cup that comes with the product—using any other device could lead to incorrect dosing. Keep the dosing cup with the product so you always have it on hand.

For children aged 6 to under 12 years, the recommended dose is between 5 to 10 milliliters (mL) every 4 hours. If your child is between 4 and 5 years old, they should receive 2.5 to 5 mL every 4 hours. It's crucial to remember that this medication should not be given to children under 4 years old. Additionally, do not take more than 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 is a type of medication used for depression, certain psychiatric conditions, or 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, please consult a doctor or pharmacist before proceeding.

If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and seek medical advice. These symptoms could indicate a more serious health issue that requires attention.

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 if they have stopped taking it within the last two weeks.

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

Warnings and Precautions

It's important to be cautious when using this medication for children. Do not give it to a child who is currently taking a 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 prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this medication, check with a 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 headache that persists, stop using the medication and contact a doctor, as these may indicate a more serious issue. In the event of an overdose, seek immediate medical assistance or call 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. 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, but specific studies or data are not available to clarify these risks. Therefore, it is crucial to consult your doctor before using this product.

Additionally, there are no specific dosage modifications mentioned for pregnant individuals, but discussing your options with a healthcare provider is strongly advised to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

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 one within the last two weeks. It's important to consult a doctor before using this medication 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 headache that persists, stop using the medication and seek medical advice.

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

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any age-related health considerations, as older adults may experience different effects from medications compared to younger individuals.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 treatments with your healthcare provider. They can help ensure that you avoid potential risks and make informed decisions about your health or your child's health.

Storage and Handling

To ensure the best results with your product, store it at room temperature, specifically between 20-25ºC (68-77ºF). It's important not to refrigerate it, as this can affect its effectiveness. Always keep the dosing cup with the product for easy and accurate measurement.

Before using, make sure to shake the product well to mix its contents thoroughly. Once opened, please remember to discard it after use to maintain safety and effectiveness. 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 Mucus Relief?

Children's Cough Mucus Relief is a medication that contains Dextromethorphan HBr (5 mg) as a cough suppressant and Guaifenesin (100 mg) as an expectorant, designed for children aged 4 to 11 years.

How does Children's Cough Mucus Relief work?

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

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

For children 6 to under 12 years, the dosage is 5-10 mL every 4 hours. For children 4 to 5 years, it is 2.5-5 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 headache that lasts.

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

The safety of this product during pregnancy has not been established, so consult a healthcare provider before use.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional 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, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Children's Cough Mucus Relief?

Store between 20-25ºC (68-77ºF), do not refrigerate, and keep the dosing cup with the product.

Packaging Info

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

Packaging configurations for Childrens Mucus Relief Cough.
Details

Drug Information (PDF)

This file contains official product information for Childrens Mucus Relief Cough, 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 alleviates the intensity of coughing and reduces the impulse to cough, which may assist children in achieving restful sleep.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage and administration guidelines.

Before administration, the product must be shaken well. The dosing cup provided with the product should be used exclusively for measuring doses; no other dosing devices should be utilized. It is essential to keep the dosing cup with the product at all times to ensure accurate measurement.

For children aged 6 to under 12 years, the recommended dosage is 5 to 10 mL every 4 hours, with a maximum of 6 doses within a 24-hour period. For children aged 4 to 5 years, the dosage is 2.5 to 5 mL every 4 hours, also not exceeding 6 doses in a 24-hour period. The product is not recommended for use in children under 4 years of age.

It is critical to monitor the total number of doses administered to prevent exceeding the maximum limit within a 24-hour timeframe.

Contraindications

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, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a lasting headache, the use of this product should be discontinued, and a healthcare provider should be consulted, as these symptoms may indicate a serious underlying condition.

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. 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 exercise caution and advise parents or guardians to seek medical advice before using this product if the child presents with a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in conditions such as asthma.

Patients should be instructed to discontinue use and consult a healthcare provider if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt action is essential to ensure the safety and well-being of the child.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It 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 such medication, as this may lead to serious interactions.

Before administering this medication to a child, it is advisable to consult a healthcare professional if the child has a cough that is accompanied by excessive phlegm or if the cough is persistent or chronic, such as that which occurs with asthma.

Patients are instructed to discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

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.

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 Relief Cough (dextromethorphan hbr, guaifensin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Mucus Relief Cough.
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 headache that lasts, the use of this medication should be discontinued, and a doctor should be consulted.

Dosing recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the recommended dose is 5-10 mL every 4 hours; for children aged 4 to 5 years, the dose is 2.5-5 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 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 possibility of polypharmacy and the presence of comorbid conditions that are common in geriatric patients, which 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 provider prior to use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned. It is strongly advised that women of childbearing potential discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential fetal outcomes.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. 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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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 at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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

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 at 1-800-222-1222 in the event of an overdose.

It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 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 healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a more serious underlying condition.

Additionally, healthcare providers should recommend that patients consult a doctor prior to use if the child has a cough associated with excessive phlegm (mucus) or if the child experiences a persistent or chronic cough, such as that which occurs with asthma.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. Prior to use, the product must be shaken well to ensure proper consistency. Once opened, the product should be discarded after use to maintain safety and efficacy.

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 Relief Cough, 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 Relief Cough, 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.

Learn more in our Editorial Policy

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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.