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Mucinex Childrens Fever Sore Throat and Cough

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Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
April 3, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/10 mL
  • Dextromethorphan Hydrobromide 10 mg/10 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
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 2024
Label revision date
April 3, 2024
Manufacturer
RB Health (US) LLC
Registration number
M012
NDC root
72854-064
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 Mucinex® Honey Flavor Liquid is a medication designed to help relieve various symptoms associated with the common cold and other minor throat and bronchial irritations. It works by temporarily reducing coughing, which can help your child sleep better, and it also alleviates minor aches and pains, sore throat, headaches, and fever.

This liquid formulation is specifically tailored for children, providing a soothing honey flavor that makes it easier for them to take. By addressing these common discomforts, Children's Mucinex® aims to support your child's comfort during illness.

Uses

This medication is designed to help you and your child feel more comfortable when dealing with common cold symptoms and other minor irritations. It temporarily relieves cough caused by minor throat and bronchial irritation, which can happen due to the common cold or inhaled irritants. If your child is having trouble sleeping because of a cough, this medication can also reduce the urge to cough, making it easier for them to rest.

In addition to easing cough, this medication helps relieve minor aches and pains, sore throat, and headaches. It can also temporarily lower fever, providing further comfort during illness. Overall, it aims to make you and your child feel better while dealing with these common health issues.

Dosage and Administration

When using this product, it's important to follow the dosing instructions carefully. For children aged 6 to under 12 years, you should measure out 10 mL using the dosing cup provided and give it to them every 4 hours as needed for their symptoms. However, make sure not to exceed 5 doses in a 24-hour period.

For children under 6 years of age, this product is not recommended, so please do not use it for them. Always use the dosing cup that comes with the product, and avoid using it with any other medications to ensure accurate measurement. If you have any questions or concerns, consult with a doctor for guidance.

What to Avoid

Before using this medication, it's important to consult a doctor if your child has liver disease, a chronic cough (like asthma), or a cough with excessive mucus. Additionally, if your child is taking the blood thinner warfarin, please check with a doctor or pharmacist first.

You should stop using the medication and seek medical advice if your child's pain or cough worsens or lasts more than five days, if a fever persists for more than three days, or if you notice any redness, swelling, or new symptoms. Be especially cautious if a cough returns with a rash or headache, as these could indicate a more serious issue. Remember, taking more than the recommended dose can lead to liver damage, so if an overdose occurs, seek immediate medical help, even if there are no noticeable symptoms.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. There is a risk of severe liver damage if your child takes more than five doses in 24 hours or uses it alongside other medications containing acetaminophen. Additionally, be cautious of potential severe skin reactions, which may include symptoms like skin reddening, blisters, or rash. If any of these occur, stop using the medication and seek medical help immediately.

You should also consult a doctor before using this medication if your child has liver disease, a chronic cough (like asthma), or a cough with excessive mucus. If your child's pain or cough worsens or lasts longer than five days, or if a fever persists for more than three days, it's important to stop use and contact a doctor. New symptoms, redness, swelling, or a cough that returns with a rash or headache could indicate a more serious condition.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if your child takes more than 5 doses in 24 hours or uses it alongside other medications containing acetaminophen. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If any of these symptoms occur, stop using the product and seek medical help immediately. Additionally, if your child has a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

To ensure safety, do not use this product with any other medications that contain acetaminophen. If you are unsure whether a medication contains acetaminophen, ask a doctor or pharmacist. Avoid giving this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one within the last 2 weeks.

In case of an overdose, seek emergency medical help or contact a Poison Control Center right away, even if no symptoms are present. You should also stop using the product and call your doctor if pain or cough worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, redness or swelling occurs, new symptoms develop, or if a cough returns with a rash or headache that lasts. These could indicate a more serious condition.

Overdose

If your child takes more than 5 doses of this medication in a 24-hour period, it can lead to severe liver damage. It's also important to be cautious if your child is using this product alongside other medications that contain acetaminophen (a common pain reliever), as this can increase the risk of liver damage.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or abdominal pain. If you notice any of these symptoms or if you believe your child has taken too much of the medication, seek immediate medical help. It's always better to be safe and consult a healthcare professional in these situations.

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 seeking medical advice is strongly recommended to ensure your safety and that of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

When it comes to using this medication for children, there are specific guidelines to follow. For children aged 6 to under 12 years, you can give them 10 mL using the dosing cup provided every 4 hours as needed for symptoms. However, it's important not to exceed 5 doses in a 24-hour period to ensure their safety.

For children under 6 years of age, this medication is not recommended, so please avoid using it for younger children. Always consult with your healthcare provider if you have any questions or concerns about administering medication to your child.

Geriatric Use

When it comes to using this product for older adults, there isn't specific information available about its use in this age group. This means that there are no tailored guidelines or warnings provided for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional before starting this medication. They can help ensure that it is safe and appropriate based on individual health needs and any other medications being taken. Always prioritize open communication with healthcare providers to address any concerns.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious with medications that contain acetaminophen. Taking more than 5 doses in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, be aware that combining this product with other medications that also contain acetaminophen can increase the risk of liver damage.

To protect your liver, always follow the dosing instructions carefully and consult your healthcare provider if you have any questions or concerns about using products with acetaminophen. Your health and safety are the top priority, so make sure to keep track of all medications you are taking.

Drug Interactions

It's important to be cautious when using this medication, especially if you or your child are taking other drugs. You should avoid using it alongside any other medications that contain acetaminophen, whether they are prescribed or available over the counter. Additionally, if your child is on a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain other conditions—this medication should not be used, and you should wait at least two weeks after stopping the MAOI before starting it.

Before using this medication, it's also wise to consult with a healthcare provider if your child is taking warfarin, a blood-thinning medication. Discussing all medications and health conditions with your doctor or pharmacist helps ensure safety and effectiveness in your treatment plan.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important to keep it away from refrigeration, as cooling can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Children's Mucinex® Honey Flavor Liquid used for?

Children's Mucinex® Honey Flavor Liquid temporarily relieves cough due to minor throat and bronchial irritation, reduces the intensity of coughing, and helps relieve minor aches, pains, sore throat, headache, and fever.

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

For children aged 6 to under 12 years, the recommended dosage is 10 mL every 4 hours while symptoms last, with a maximum of 5 doses in any 24-hour period.

Can I give Children's Mucinex to children under 6 years of age?

No, do not use this product in children under 6 years of age.

What should I do if my child's symptoms worsen?

Stop use and ask a doctor if pain or cough gets worse or lasts more than 5 days, or if fever gets worse or lasts more than 3 days.

Are there any warnings associated with this product?

Yes, this product contains acetaminophen, which can cause severe liver damage if more than 5 doses are taken in 24 hours or if used with other acetaminophen-containing drugs.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

Is it safe to use Children's Mucinex during pregnancy?

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

What are the storage instructions for Children's Mucinex?

Store Children's Mucinex at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

Below are the non-prescription pack sizes of Mucinex Childrens Fever Sore Throat and Cough (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Childrens Fever Sore Throat and Cough.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's Mucinex® is a honey-flavored liquid formulation designed for pediatric use. It is packaged in a 4 fluid ounce (118 mL) bottle. The product is identified by the National Drug Code (NDC) 72854-064.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or inhaled irritants. It is effective in reducing the intensity of coughing and the impulse to cough, thereby assisting children in achieving restful sleep. Additionally, this drug provides relief from minor aches and pains, sore throat, and headache, and it temporarily reduces fever.

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

Dosage and Administration

This product is intended for use in children aged 6 to under 12 years. The recommended dosage is 10 mL, administered orally using the dosing cup provided, every 4 hours while symptoms persist. It is important not to exceed 5 doses within a 24-hour period.

For children under 6 years of age, this product is not recommended for use.

Healthcare professionals should ensure that the dosing cup provided is used exclusively for this product and not with any other medications. Care should be taken to adhere to the specified dosing instructions to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should consult a healthcare professional prior to use if the child has liver disease, chronic cough associated with asthma, or cough accompanied by excessive phlegm (mucus). Additionally, consultation is advised if the child is concurrently taking the anticoagulant warfarin due to potential interactions.

Discontinue use and seek medical advice if pain or cough worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. A return of cough or its occurrence alongside a rash or headache that persists warrants immediate medical evaluation, as these may indicate a serious condition.

Overdose of this product may lead to liver damage; therefore, exceeding the recommended dosage is contraindicated. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, even in the absence of symptoms.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to monitor the total intake of acetaminophen from all sources to prevent potential toxicity.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should caution against the concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to consult a doctor or pharmacist.

This product should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as these drugs are used for treating depression, psychiatric or emotional conditions, or Parkinson’s disease. Caregivers should be encouraged to verify the presence of MAOIs in their child’s prescription medications by consulting a healthcare professional.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a doctor if any of the following occur: pain or cough worsens or persists beyond 5 days; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the medication are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases when the medication is used concurrently with other drugs containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Before using this medication, it is advisable for patients to consult a healthcare professional if they have a history of liver disease, chronic cough (such as that which occurs with asthma), or cough associated with excessive phlegm (mucus).

Patients are instructed to stop use and seek medical advice if any of the following occur: pain or cough worsens or lasts more than 5 days; fever worsens or lasts more than 3 days; redness or swelling is present; new symptoms develop; or if a cough recurs or occurs with a rash or headache that lasts. These symptoms could indicate a serious condition requiring medical evaluation.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

In pediatric patients, this medication should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is advised to avoid use for at least two weeks following the discontinuation of an MAOI to prevent serious interactions.

Caution is advised when considering the use of this medication in children who are concurrently taking the anticoagulant warfarin. It is recommended to consult a healthcare professional, such as a doctor or pharmacist, prior to use to ensure safe and effective management of potential drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Childrens Fever Sore Throat and Cough (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Childrens Fever Sore Throat and Cough.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 10 mL using the dosing cup provided every 4 hours as needed for symptom relief, with a maximum of 5 doses in a 24-hour period. For children under 6 years of age, the use of this medication is not recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this population. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of geriatric patients.

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 prior to use. 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 medical advice be sought before using this product during pregnancy to ensure the safety of both the patient and the developing fetus.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed the maximum daily amount of 5 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen to mitigate the risk of hepatotoxicity.

Healthcare providers should assess liver function prior to initiating treatment and consider regular monitoring of liver enzymes during therapy, particularly in patients with known liver dysfunction. Adjustments to dosing or alternative therapies may be necessary based on the severity of hepatic impairment.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients for signs of hepatotoxicity, especially in instances of dosing errors or accidental ingestion.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk for liver injury. It is essential to assess the patient's medication history thoroughly to identify any potential interactions that could exacerbate the risk of overdosage.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function tests. If indicated, the administration of N-acetylcysteine may be considered as an antidote to mitigate the effects of acetaminophen toxicity.

Prompt recognition and intervention are crucial in minimizing the risk of severe complications associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial even if no signs or symptoms are present.

Patients should be encouraged to consult a doctor before using this medication if the child has any of the following conditions: liver disease, a chronic cough lasting as seen in asthma, or a cough accompanied by excessive phlegm (mucus). Additionally, it is essential to recommend that patients speak with a doctor or pharmacist prior to use if the child is currently taking the blood-thinning medication warfarin.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: pain or cough worsens or persists for more than 5 days; fever worsens or lasts more than 3 days; there is the presence of redness or swelling; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition that requires medical evaluation.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as exposure to lower temperatures may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Mucinex Childrens Fever Sore Throat and 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 Mucinex Childrens Fever Sore Throat and 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.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.