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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 2016
Label revision date
April 8, 2024
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 2016
Label revision date
April 8, 2024
Manufacturer
H E B
Registration number
M012
NDC root
37808-594
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 Relief Cough is a medication designed for children aged 4 to 11 years, featuring a cherry flavor and alcohol-free formulation. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination works to relieve coughs caused by minor throat and bronchial irritation, such as those associated with the common cold or inhaled irritants, making coughs more productive and helping your child sleep better.

By easing chest congestion and reducing the impulse to cough, Children's Mucus Relief Cough provides temporary relief from bothersome symptoms, allowing your child to feel more comfortable.

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 it to temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with common colds or when you inhale 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; avoid using any other measuring devices to ensure you get the correct amount. Keep the dosing cup with the product for easy access.

For children aged 6 to under 12 years, the recommended dose is between 5 to 10 milliliters (mL) every 4 hours, but remember not to exceed 6 doses in a 24-hour period. For younger children aged 4 to 5 years, the dose is 2.5 to 5 mL every 4 hours. However, if your child is under 4 years old, do not use this medication. Always adhere to these guidelines to help keep your child safe and healthy.

What to Avoid

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

Taking this medication inappropriately can lead to serious health risks, so please follow these guidelines carefully to ensure 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 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 using this product, consult a doctor if your child has a cough with excessive mucus or a persistent cough, such as one caused by 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 lasting headache, as these may 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

You should not use this medication for a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of 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 giving this medication to your child, it's important to ask a doctor if they have a cough that produces a lot of mucus or a persistent cough, such as one associated with asthma. If your child experiences an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, stop using the medication and call your doctor if the cough lasts more than seven days, returns, or is accompanied by fever, rash, or a headache that persists, as these may indicate a more serious issue.

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 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, so it is generally advised to avoid using this product unless it is clearly necessary. Always consult your doctor before using it, as they can provide guidance tailored to your specific situation.

There are no specific dosage modifications for pregnant individuals, but discussing your options with a healthcare provider is crucial to ensure the best outcome for you and your baby.

Lactation Use

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

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

It's important to be cautious when giving medication to children. You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks. Before using it, consult your doctor if your child has a cough with a lot of 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 headache, 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 prioritize your child's safety and consult a healthcare professional with any concerns.

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 doctor is aware of your age and any existing health conditions, as this can influence treatment decisions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 may affect you 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 crucial to be aware of potential interactions when considering medications for yourself or your child. For instance, if your child is taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain psychiatric conditions—this product should not be used. Additionally, it should not be taken 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 healthcare provider or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure safety and effectiveness. They can help you navigate potential interactions and make informed decisions about your child's health.

Storage and Handling

To ensure the best results, store the product 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 accurate measurement, and remember to shake the bottle well before each use to mix the contents properly.

For your safety, check that the carton is sealed and that the printed safety seal around the bottle or under the cap is intact. If you find that the carton is opened or the seal is broken or missing, do not use the product. After opening, please discard any unused product 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 Relief Cough?

Children's Mucus Relief Cough is a cough suppressant and expectorant containing Dextromethorphan HBr 5 mg and Guaifenesin 100 mg, designed for children ages 4 to 11 years.

How does Children's Mucus Relief Cough 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 Mucus Relief Cough?

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 children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if unsure.

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

Stop use and consult a doctor if the cough lasts more than 7 days, returns, or occurs with fever, rash, or headache.

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

The safety of this product during pregnancy has not been established, and it should be avoided unless clearly needed. Consult a healthcare provider.

What are the storage instructions for Children's Mucus Relief Cough?

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

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

It comes in a cherry flavor and is alcohol-free.

Packaging Info

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

Packaging configurations for Mucus Relief Cough.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation contains Dextromethorphan HBr at a concentration of 5 mg, serving as a cough suppressant, and Guaifenesin at 100 mg, functioning as an expectorant. The product is alcohol-free and features a cherry flavor. It is intended for use in children aged 4 to 11 years and provides relief from cough, chest congestion, and mucus.

The product is not manufactured or distributed by Reckitt Benckiser, the distributor of Children's Mucinex® Cough. It is packaged with a tamper-evident seal; do not use if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. This product is made with pride and care for H-E-B®, located in San Antonio, TX 78204.

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

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 limit 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 adhering to the maximum of 6 doses in a 24-hour period.

It is important to note that this product 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, 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 medication is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such treatment 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 physician or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription regimen.

Before administering this medication, 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 seen in conditions such as asthma. These symptoms may indicate underlying health issues that require further evaluation.

In the event of an overdose, immediate medical assistance should be sought. Caregivers are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child's cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may signify a serious medical condition that necessitates further investigation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this medication. It is contraindicated for use in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is essential to consult a healthcare professional prior to administration.

Before using this medication, it is advisable to consult a doctor if the child has a cough accompanied by excessive phlegm or if the cough is persistent or chronic, as may occur in asthma.

Patients should discontinue use and seek medical advice 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 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 concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes patients who are currently taking prescription MAOIs for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be administered to children who have taken an MAOI within the past two weeks.

Healthcare professionals are advised to confirm whether a child's prescription medication contains an MAOI prior to the initiation of this product. It is essential to consult with a doctor or pharmacist for clarification and to ensure patient safety.

Packaging & NDC

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

Packaging configurations for 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 use, it is advisable to consult a healthcare professional if the child has a cough associated with excessive phlegm (mucus) or a persistent/chronic 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 headache that lasts, the medication should be discontinued, and a doctor should be consulted.

Dosing varies by age: 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 presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased 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. There may be potential risks to the fetus; therefore, use of this product should be avoided unless clearly needed. No specific dosage modifications are provided for pregnant individuals. 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 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide supportive care and monitor the patient closely for any adverse effects that may arise from the overdose.

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 compound in these areas.

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 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 healthcare professional if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a 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 safety, the packaging is tamper evident; therefore, it should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. After opening, the product should be discarded.

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 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 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.