Symptom checker
Select audience type

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

ADD CONDITION

items per page

Cough Dm

Last content change checked dailysee data sync status

Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Dosage form
Suspension, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
September 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Dosage form
Suspension, Extended Release
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 2015
Label revision date
September 8, 2025
Manufacturer
Sixarp, LLC
Registration number
ANDA091135
NDC root
59368-260
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 a cough suppressant that contains dextromethorphan polistirex, designed to provide temporary relief from coughing caused by minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. This medication helps reduce the urge to cough, making it easier for you to rest and sleep.

With its extended-release formula, Cough DM offers up to 12 hours of cough relief. It comes in a grape-flavored liquid form and is alcohol-free, making it a suitable option for those looking for a soothing solution to manage their cough symptoms.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which can happen with the common cold or from inhaling irritants. If you're having trouble sleeping because of a persistent cough, this medication can also help reduce the urge to cough, allowing you to rest more comfortably.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

Before you use this 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 over, 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.

Be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals. 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 may indicate a more serious condition.

Side Effects

You should be aware of some important warnings and potential side effects associated with this medication. First, do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist. Additionally, this product 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. You should also seek medical advice if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue. You can report 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. If you have recently stopped taking an MAOI, wait at least two weeks before using this product. 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. You should stop using the product and contact your doctor if you experience any side effects, if your cough lasts more than seven days, or if it returns with symptoms like fever, rash, or a persistent headache, as these may indicate a more serious issue.

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 your health, 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, it’s important to consult with a healthcare provider before starting the medication. 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 your kidneys are not functioning properly.

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 help monitor your condition 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 may affect you if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment is safe and effective.

Always feel free to ask questions and share all the medications, supplements, or tests you are using. This way, you can work together to avoid any potential issues and make informed decisions about your health.

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, you will find a dosing cup included, which is designed to help you measure the correct amount safely. Always handle the product with care to avoid any contamination or damage. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication according to the following guidelines: Adults and children aged 12 and older can take 10 mL every 12 hours, with a maximum of 20 mL in 24 hours. For children aged 6 to under 12 years, the dose is 5 mL every 12 hours, not exceeding 10 mL in 24 hours. Children aged 4 to under 6 years should take 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. This medication is not recommended for children under 4 years of age.

Before using this medication, consult a doctor if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough produces a lot of mucus. If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before use. If you experience any side effects, stop using the medication and contact your doctor. You can also report side effects to the FDA at 1-800-FDA-1088.

FAQ

What is Cough DM?

Cough DM is a cough suppressant that contains dextromethorphan polistirex extended-release oral suspension, designed to temporarily relieve cough due to minor throat and bronchial irritation.

How does Cough DM work?

It temporarily relieves the impulse to cough, helping you get to sleep and alleviating cough caused by common colds or inhaled irritants.

What is the recommended dosage for adults?

Adults and children 12 years and over should take 10 mL every 12 hours, not exceeding 20 mL in 24 hours.

Can children use Cough DM?

Children aged 6 to under 12 years can take 5 mL every 12 hours, while those aged 4 to under 6 years can take 2.5 mL every 12 hours. Do not use in children under 4 years of age.

Are there any contraindications for using Cough DM?

Do not use Cough DM if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks.

What should I do if I experience side effects?

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

Is Cough DM safe during pregnancy or breastfeeding?

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

What should I know about allergies related to Cough DM?

Cough DM contains sodium metabisulfite, which may cause allergic-type reactions in some individuals.

How should I store Cough DM?

Store Cough DM at a temperature between 20° to 25°C (68° to 77°F).

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Cough Dm.
Details

Drug Information (PDF)

This file contains official product information for 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 for the specified drug.

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 recommended for use in children under 4 years of age. Dosing should be conducted as directed by a healthcare professional when necessary.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Additionally, this product contains sodium metabisulfite, which may provoke allergic-type reactions in susceptible individuals.

Patients should discontinue use and consult a healthcare provider if side effects occur, or if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, as these may indicate a serious underlying condition.

Warnings and Precautions

Do not use this product if currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

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

Before using this product, it is advisable to consult a healthcare provider if the patient has a chronic cough associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Patients should discontinue use and seek medical advice 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 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, these may indicate a serious underlying condition requiring medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222 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 or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in patients taking MAOIs or within 2 weeks of stopping such medication. It is essential for patients to consult with a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Additionally, an allergy alert is warranted as the product contains sodium metabisulfite, which is a sulfite that may provoke allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and seek medical attention if side effects occur. It is also recommended that patients consult a healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious underlying condition. Side effects can be reported to the FDA at 1-800-FDA-1088.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for 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 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 assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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. Healthcare professionals should advise patients or caregivers to call 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. Depending on the specific circumstances of the overdose, additional treatments may be warranted to mitigate adverse effects and ensure patient safety.

Nonclinical Toxicology

If pregnant or breast-feeding, 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 specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified that the product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals. Users are advised to discontinue use and consult a healthcare professional if side effects occur. Additionally, it is recommended that individuals report any side effects to the FDA at 1-800-FDA-1088.

Reports indicate that if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, these symptoms may indicate a serious underlying condition.

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. These symptoms may indicate a serious underlying condition. Furthermore, patients should be encouraged to consult a doctor before using the 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

Patients aged 12 years and older are advised to administer 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 recommended dosage is 5 mL every 12 hours, not exceeding 10 mL in 24 hours. Children aged 4 to under 6 years should receive 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. The medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to consult a doctor prior to use if they have a chronic cough associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use. Patients are also advised to discontinue use and consult a doctor if side effects occur, with the option to report adverse effects to the FDA at 1-800-FDA-1088.

Drug Information (PDF)

This file contains official product information for 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 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.