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Leader Childrens Cough Dm

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Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Suspension
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
June 17, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Suspension
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
June 17, 2021
Manufacturer
Cardinal Health 110, LLC. dba Leader
Registration number
ANDA091135
NDC root
70000-0195
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 DM is a cough suppressant that comes in an orange-flavored liquid form, designed for both children and adults aged 4 and older. It contains dextromethorphan polistirex, which works by temporarily relieving cough caused by minor throat and bronchial irritation, such as that which may occur with the common cold or from inhaled irritants. This medication can also help reduce the urge to cough, making it easier for you to get to sleep.

This product provides up to 12 hours of cough relief and is alcohol-free, ensuring a safer option for your family. A dosing cup is included for easy measurement, and it does not contain any fever reducers or pain relievers.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a common cold or from inhaling irritants, this medication can help. It works by temporarily relieving your cough, making it easier for you to go about your day.

Additionally, if your cough is keeping you awake at night, this medication can help reduce the urge to cough, allowing you to get a better night's sleep.

Dosage and Administration

Before you use the medication, make sure to shake the bottle well. It's important to measure your dose using only the dosing cup that comes with the product, as using it with other products can lead to incorrect dosing.

For adults and children aged 12 and older, the recommended dose is 10 mL every 12 hours, but you should not take more than 20 mL in a 24-hour period. If your child is between 6 and 12 years old, the dose is 5 mL every 12 hours, with a maximum of 10 mL in a day. For children aged 4 to under 6 years, the dose is 2.5 mL every 12 hours, not exceeding 5 mL in 24 hours. Please do not use this medication for children under 4 years of age. Always follow your doctor’s instructions if they provide different guidance.

What to Avoid

You should avoid using this product 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. Additionally, do not use it for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's also important to note that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals. Always prioritize your safety by checking with a healthcare professional if you have any concerns about potential interactions or allergies.

Side Effects

You should be aware that this medication contains sodium metabisulfite, which can cause allergic reactions in some people. If you experience any side effects, it's important to stop using the medication and consult your doctor. Additionally, if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious health issue, and you should seek medical attention. You can report any side effects to the FDA at 1-800-FDA-1088.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, 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. Additionally, be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals.

Before using this product, it's important to talk to your doctor if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough is accompanied by excessive mucus. If you experience any side effects, or if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or headache, stop using the product and contact your doctor. These symptoms could indicate a more serious condition.

In the event of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about a possible overdose, don’t hesitate to reach out for help right away. Your safety is the top priority.

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

When giving this medication to your child, it's important to follow the recommended dosages based on their age. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, but you should not exceed 10 mL in a 24-hour period. If your child is between 4 and under 6 years old, the dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours.

Please note that this medication is not recommended for children under 4 years of age, so it's crucial to avoid using it for younger children. Always consult with your healthcare provider if you have any questions or concerns about your child's medication.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's crucial to be aware of potential interactions when taking medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease, you should not take this product. Additionally, you need to 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 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 of your product, store it at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When using the product, a dosing cup is provided to help you measure the correct amount easily. Always handle the product with care to avoid contamination and ensure it remains safe for use.

Additional Information

You should take this medication orally. It's important to be aware that it contains sodium metabisulfite, which can cause allergic reactions in some people. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Children's Cough DM?

Children's Cough DM is a dextromethorphan polistirex extended-release oral suspension that temporarily relieves cough due to minor throat and bronchial irritation.

Who can use Children's Cough DM?

Children's Cough DM is for children aged 4 and older, as well as adults.

How should I take Children's Cough DM?

Shake the bottle well before use and measure the dose with the provided dosing cup. Follow the dosing instructions based on age.

What are the dosing instructions for Children's Cough DM?

Adults and children 12 years and older should take 10 mL every 12 hours. Children 6 to under 12 years should take 5 mL, and children 4 to under 6 years should take 2.5 mL, both every 12 hours.

Are there any contraindications for using Children's Cough DM?

Do not use 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 side effects?

Stop use and ask a doctor if side effects occur, or if your cough lasts more than 7 days or comes back with fever, rash, or headache.

Is Children's Cough DM safe during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What is the allergy alert for Children's Cough DM?

Children's Cough DM contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

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.

What flavor is Children's Cough DM?

Children's Cough DM is an orange-flavored liquid.

Packaging Info

Below are the non-prescription pack sizes of Leader Childrens Cough Dm (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Childrens Cough Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dextromethorphan Polistirex Extended-Release Oral Suspension is a cough suppressant formulated as an orange-flavored liquid. Each bottle contains 3 fluid ounces (89 mL) of the suspension. The formulation includes sodium metabisulfite, which is a sulfite that may cause allergic-type reactions in sensitive individuals.

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 as a result of inhaled irritants. It also serves to relieve the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

The bottle should be shaken well before use. Dosing must be measured exclusively with the dosing cup provided; the dosing cup should not be used with any other products to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 10 mL every 12 hours, with a maximum of 20 mL in a 24-hour period. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, not to exceed 10 mL in a 24-hour period. For children aged 4 to under 6 years, the appropriate dose is 2.5 mL every 12 hours, with a maximum of 5 mL in a 24-hour period. This product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that patients adhere to these dosing guidelines or follow any specific instructions provided by their healthcare provider.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Additionally, this product contains sodium metabisulfite, which may cause allergic-type reactions in individuals with sulfite sensitivity.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is also advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Allergy Alert This product contains sodium metabisulfite, which is a sulfite that may provoke allergic-type reactions in susceptible individuals. Patients with known sulfite allergies should be advised accordingly.

General Precautions Prior to using this product, patients should consult a healthcare provider if they have a chronic cough associated with smoking, asthma, or emphysema. Additionally, individuals experiencing a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before use.

Stop Taking and Call Your Doctor Instructions Patients are instructed to discontinue use and consult a healthcare professional if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, patients should seek medical attention, as these symptoms may indicate a serious underlying condition.

Get Emergency Medical Help Instructions In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Notably, the formulation contains sodium metabisulfite, which may lead to allergic-type reactions in susceptible individuals. Therefore, patients with a known allergy to sulfites should avoid using this product.

In the event that side effects occur, patients are advised to discontinue use and consult a healthcare professional. It is important to report any side effects to the FDA at 1-800-FDA-1088. Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, patients should seek medical attention, 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 or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a period 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 medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Leader Childrens Cough Dm (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Childrens Cough Dm.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL every 12 hours, with a maximum dosage of 10 mL in a 24-hour period. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. The use of 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, 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

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 individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. The product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in sensitive individuals. No additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology has been extracted.

Postmarketing Experience

Postmarketing experience has identified the presence of sodium metabisulfite in the formulation, which is a sulfite that may lead to allergic-type reactions in susceptible individuals. Additionally, side effects have been reported. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

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 product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Providers should alert patients to the presence of sodium metabisulfite in the formulation, which may trigger allergic-type reactions in susceptible individuals. Patients must be instructed to discontinue use and consult a doctor if they experience any side effects. Additionally, they should be informed that side effects can be reported to the FDA at 1-800-FDA-1088.

Patients should be advised to stop using the product and seek medical advice if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if they have a chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for maintaining the integrity of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should inform patients that the product contains sodium metabisulfite, which may trigger allergic-type reactions in susceptible individuals. Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Leader Childrens Cough Dm, 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 Leader Childrens Cough Dm, 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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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.