Symptom checker
Select audience type

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

ADD CONDITION

items per page

Leader Cough Dm

Last content change checked dailysee data sync status

Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
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
September 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
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
September 15, 2025
Manufacturer
Sixarp, LLC
Registration number
ANDA091135
NDC root
59368-266
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

Cough DM is an extended-release oral suspension that contains dextromethorphan polistirex, a cough suppressant designed to help relieve coughing. This orange-flavored liquid is alcohol-free and comes with a dosing cup for your convenience. It works by temporarily relieving cough caused by minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. Additionally, it can help reduce the urge to cough, making it easier for you to get a good night's sleep.

With a formulation that provides up to 12 hours of cough relief, Cough DM is a suitable option for those seeking to manage their cough symptoms effectively. However, it's important to ensure that the carton is unopened and the foil under the cap is intact before use.

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 you're struggling to sleep because of the urge to cough, this medication can also help reduce that impulse, allowing you to rest more comfortably.

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 prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

Be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals. If you have a known allergy to sulfites, it's important to avoid this product. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

Side Effects

You should be aware that this medication contains sodium metabisulfite, which can cause allergic reactions in some individuals. 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 be signs of a more serious condition, 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), 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. Additionally, be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some people.

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 a persistent 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

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency services or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 children, 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 a total of 10 mL in a 24-hour period. For younger children aged 4 to under 6 years, the dosage is reduced to 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. Always consult with your child's healthcare provider if you have any questions or concerns about their treatment.

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 ensure that your healthcare provider is aware of your age and any existing health conditions, as this can influence how the medication works for you. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 should be used 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 you understand how to manage your treatment effectively while considering 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 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 important to be cautious when taking certain medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should avoid using this medication. Taking these together can lead to serious interactions that may affect your health.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that your treatments are safe and effective, and they can provide guidance on any potential interactions with other drugs or tests. Your safety is the top priority, so don't hesitate to ask questions about your medications.

Storage and Handling

To ensure the best results with your product, store it in a cool, dry place at a temperature between 20 °C to 25 °C (68 °F to 77 °F). Before using, make sure to shake the bottle well to mix the contents thoroughly. Always use the dosing cup provided to measure your dosage, and avoid using it with any other products to maintain safety and accuracy.

Once you open the carton or if the printed foil under the cap is broken or missing, please discard the product to ensure your safety. Following these guidelines will help you use the product effectively and safely.

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 Cough DM?

Cough DM is an extended-release oral suspension that contains Dextromethorphan Polistirex, which acts as a cough suppressant. It is an orange-flavored, alcohol-free liquid.

How does Cough DM work?

Cough DM temporarily relieves cough due to minor throat and bronchial irritation, which may occur with the common cold or inhaled irritants. It also helps relieve the impulse to cough to assist with sleep.

What are the dosing instructions for Cough DM?

Adults and children 12 years and older should take 10 mL every 12 hours, not exceeding 20 mL in 24 hours. For children 6 to under 12 years, the dose is 5 mL every 12 hours, and for children 4 to under 6 years, it is 2.5 mL every 12 hours.

Are there any warnings associated with Cough DM?

Do not use Cough DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. It also contains sodium metabisulfite, which may cause allergic-type reactions.

What should I do if I experience side effects?

If side effects occur, stop using Cough DM and consult a doctor. You can report side effects to the FDA at 1-800-FDA-1088.

Can I use Cough DM if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Cough DM.

How should I store Cough DM?

Store Cough DM at 20 °C to 25 °C (68 °F to 77 °F) and shake the bottle well before use. Discard the product if the carton is opened or the printed foil under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Leader Cough Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available.

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. Additionally, it is indicated for the temporary relief of the impulse to cough, 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 use of this cup with other products is not recommended.

For adults and children aged 12 years and older, the recommended dosage is 10 mL every 12 hours, with a maximum limit of 20 mL within 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 dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. This product is not indicated for use in children under 4 years of age.

Healthcare professionals should ensure that patients adhere to these dosing guidelines or any adjustments as directed by a physician.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their prescription.

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

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 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.

Allergy Alert This product contains sodium metabisulfite, which is a sulfite that may provoke allergic-type reactions in susceptible individuals.

General Precautions Before using this product, patients should seek medical advice if they have a chronic cough associated with smoking, asthma, or emphysema, or if they experience a cough accompanied by excessive phlegm (mucus).

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

Get Emergency Medical Help Instructions In the event of an overdose, it is crucial 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 medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on an MAOI or for a period of two weeks following the discontinuation of an MAOI. The combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

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

Packaging configurations for Leader 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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and mental status. Monitor for any signs of toxicity or adverse reactions.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, intravenous fluids, and monitoring in a controlled environment.

  3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration to limit further absorption of the substance. However, this should be avoided in cases of altered consciousness or risk of aspiration.

  4. Specific Antidotes: If applicable, administer specific antidotes as indicated for the substance involved in the overdose.

  5. Consultation: Engage with a poison control center or toxicology expert for guidance on management and treatment protocols tailored to the specific situation.

  6. Documentation: Ensure thorough documentation of the incident, including the substance involved, estimated dose, time of ingestion, and all interventions performed.

Healthcare professionals are encouraged to familiarize themselves with the management protocols for potential overdoses related to the specific substances they may encounter in their practice.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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.

Patients are advised to discontinue use and consult a healthcare professional if side effects occur. Additionally, side effects can be reported 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 they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients who are uncertain whether their prescription medication contains an MAOI should be encouraged to consult with their doctor or pharmacist prior to using this product.

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

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

Storage and Handling

The product is supplied in a bottle that requires careful handling and storage to maintain its integrity. It should be stored at a temperature range of 20 °C to 25 °C (68 °F to 77 °F). Prior to use, the bottle must be shaken well to ensure proper mixing of the contents.

For accurate dosing, it is essential to use only the dosing cup provided with the product. The dosing cup should not be used with any other products to prevent cross-contamination. Additionally, if the carton is opened or if the printed foil under the cap is broken or missing, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should inform patients that the formulation 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 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 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.

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.