Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Mucinex Childrens Mighty Chews Cough

Last content change checked dailysee data sync status

Active ingredient
Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet, Chewable
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
July 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet, Chewable
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
July 18, 2024
Manufacturer
RB Health (US) LLC
Registration number
M012
NDC root
72854-081
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® is a cough suppressant that contains the active ingredient dextromethorphan HBr (a medication that helps reduce coughing). It is designed to temporarily relieve cough caused by minor throat and bronchial irritation, which can happen during a cold. This product is suitable for children aged 6 and older and comes in a chewable tablet form with a pleasant mixed berry flavor.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens when you have a cold. It helps soothe your symptoms, making it easier for you to feel comfortable while you recover.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

You should take this medication every 4 hours, or as your doctor directs. It’s important to chew the tablets thoroughly before swallowing them to ensure they work effectively.

For adults and children aged 12 and older, the recommended dose is 2 chewable tablets every 4 hours, but you should not take more than 12 tablets in a 24-hour period. If your child is between 6 and 12 years old, they should take 1 chewable tablet every 4 hours, with a maximum of 6 tablets in a day. Please note that this medication is not suitable for children under 6 years of age, so avoid using it for that age group.

What to Avoid

If you are pregnant or breastfeeding, it’s important to consult a healthcare professional before using this medication. Additionally, you should keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help.

Remember, your safety is a priority, so always follow these guidelines to ensure proper use.

Side Effects

You should avoid using this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. It's important to consult your doctor before using this product if you are on a sodium-restricted diet, have a persistent cough due to smoking, asthma, or emphysema, or if your cough is accompanied by excessive mucus.

While using this medication, make sure not to exceed the recommended dosage. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or headache, you should stop using the product and consult your doctor, as these symptoms may indicate a more serious condition.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before using this product.

Before using this product, it's important to talk to your doctor if you have a sodium-restricted diet, a persistent cough due to smoking, asthma, or emphysema, or if your cough produces a lot of mucus. Always follow the recommended dosage and do not exceed it. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or headache, stop using the product and contact your doctor, as these may indicate a more serious issue.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

It's important to follow the recommended dosage when using this product. Taking more than the suggested amount can lead to an overdose, which may cause serious health issues. Signs of an overdose can include symptoms like extreme drowsiness, confusion, or difficulty breathing.

If you suspect an overdose, seek immediate medical help. It's crucial to act quickly, as timely intervention can make a significant difference in your recovery. Always remember, when it comes to medication, sticking to the recommended dosage is key to ensuring your safety and well-being.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 6 years old, it's important to know that this medication should not be used for them. For children aged 6 to under 12 years, the recommended dosage is 1 chewable tablet every 4 hours, but make sure not to give more than 6 chewable tablets in a 24-hour period.

For older children and adults, aged 12 years and over, the dosage increases to 2 chewable tablets every 4 hours, with a maximum of 12 chewable tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney issues, 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

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 provide guidance based on your individual situation.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity of the device and its components.

When handling the product, be sure to do so with clean hands and in a sterile environment to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of the product once it is no longer needed.

Additional Information

No further information is available.

FAQ

What is Children's Mucinex® used for?

Children's Mucinex® is a cough suppressant that temporarily relieves cough due to minor throat and bronchial irritation, which may occur with a cold.

What is the active ingredient in Children's Mucinex®?

The active ingredient in Children's Mucinex® is Dextromethorphan HBr 5 mg.

What age group can use Children's Mucinex®?

Children's Mucinex® is indicated for use in children aged 6 years and older.

How should I take Children's Mucinex®?

You should take Children's Mucinex® every 4 hours or as directed by a doctor, chewing the tablets thoroughly before swallowing.

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

Children aged 6 to under 12 years can take 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in any 24-hour period.

What is the maximum dosage for adults and children 12 years and older?

Adults and children 12 years of age and over can take 2 chewable tablets every 4 hours, not to exceed 12 chewable tablets in any 24-hour period.

Are there any contraindications for using Children's Mucinex®?

Do not use Children's Mucinex® if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Can I use Children's Mucinex® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Children's Mucinex®.

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

Stop using Children's Mucinex® and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache.

Packaging Info

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

Packaging configurations for Mucinex Childrens Mighty Chews Cough.
Details

Drug Information (PDF)

This file contains official product information for Mucinex Childrens Mighty Chews 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 cough suppressant formulated for pediatric use in children aged 6 years and older. Each chewable tablet contains 5 mg of dextromethorphan hydrobromide (HBr) as the active ingredient. The product is presented in a mixed berry flavor, designed to enhance palatability for younger patients. The National Drug Code (NDC) for this formulation is 72854-061-16.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 chewable tablets every 4 hours, with a maximum limit of 12 chewable tablets within a 24-hour period. For children aged 6 to under 12 years, the dosage is 1 chewable tablet every 4 hours, not to exceed 6 chewable tablets in a 24-hour period.

It is essential that the tablets are chewed thoroughly before swallowing to ensure proper absorption.

Use of this medication is not recommended for children under 6 years of age. Healthcare professionals should advise patients to follow these guidelines closely and to consult a physician if there are any questions or concerns regarding the appropriate use of this medication.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding; consultation with a healthcare professional is advised prior to use in these populations.

Additionally, the product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

Patients should not use this product if they 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 of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: a sodium-restricted diet, a persistent or chronic cough associated with smoking, asthma, or emphysema, or a cough that produces excessive phlegm (mucus).

While using this product, it is crucial that patients adhere strictly to the recommended dosage and not exceed it.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. The use of this product is contraindicated in such cases.

Common adverse reactions may include symptoms related to the respiratory system. Patients with a sodium-restricted diet, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or cough accompanied by excessive phlegm should consult a healthcare professional before using this product.

During the use of this product, it is crucial for patients to adhere to the recommended dosage. Exceeding this dosage may lead to adverse effects. Patients are advised to discontinue use and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious underlying condition.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Mucinex Childrens Mighty Chews Cough.
Details

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 1 chewable tablet every 4 hours, with a maximum of 6 chewable tablets in a 24-hour period. In contrast, adults and children 12 years of age and older may take 2 chewable tablets every 4 hours, not exceeding 12 chewable tablets in a 24-hour period.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Exceeding the recommended dosage of this product may lead to serious health consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage and to educate patients on the importance of adhering to the prescribed dosage guidelines.

In the event of suspected overdosage, it is crucial to assess the patient for potential symptoms, which may vary depending on the specific product and individual patient factors. Common symptoms associated with overdosage may include, but are not limited to, gastrointestinal disturbances, neurological effects, and cardiovascular complications.

Management of overdosage should be initiated promptly. Healthcare providers should consider supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and, if necessary, implementing specific interventions based on the symptoms presented. In cases of severe overdosage, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is imperative that healthcare professionals remain vigilant and proactive in preventing overdosage by ensuring that patients are well-informed about the risks associated with exceeding the recommended dosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

Providers should also emphasize the importance of keeping the medication out of reach of children. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring the safety and well-being of both patients and their families.

Storage and Handling

The product is supplied in a package configuration that includes NDC numbers relevant to its identification. It should be stored in a cool, dry place, maintaining a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Mucinex Childrens Mighty Chews 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 Mighty Chews 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

Last AI update:

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.