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Cough Dm

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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 2012
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 2012
Label revision date
September 15, 2025
Manufacturer
Sixarp, LLC
Registration number
ANDA091135
NDC root
59368-265
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

Dextromethorphan Polistirex Extended-Release Oral Suspension is a cough suppressant designed to provide relief from coughing for up to 12 hours. This orange-flavored liquid is alcohol-free and is intended to temporarily relieve cough caused by minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. It works by helping to reduce the urge to cough, making it easier for you to rest and sleep.

This medication is similar to the active ingredient found in Delsym®, and it comes in a convenient 3 FL OZ (89 mL) bottle with a dosing cup included for easy measurement.

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 a persistent cough, this medication can also help reduce the urge to cough, allowing you to rest more comfortably.

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 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, you should 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 before using this product.

It's also important to note that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals. Always prioritize your safety and seek professional advice 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 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), 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 produces a lot of 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 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

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or a poison control center for guidance on what to do next. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risks.

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 make sure not to 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 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 are no specific guidelines about adjusting the dosage or any unique safety concerns. This means that, generally, the same dosage may be used for older patients as for younger adults. However, it's always important to consult with a healthcare provider to ensure that the medication is appropriate for your individual health needs, especially if you have other medical conditions or are taking multiple medications.

As you age, your body may process medications differently, so staying in close communication with your doctor can help manage any potential risks. Always report any unusual symptoms or side effects you experience while taking the medication.

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 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 be cautious when taking medications like dextromethorphan. You should not use dextromethorphan if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), or for at least two weeks after stopping an MAOI. This is because combining these medications can lead to serious interactions that may affect your health.

Always discuss any medications you are taking, including over-the-counter drugs, 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 medications or tests. Your safety is the top priority, so don't hesitate to ask questions.

Storage and Handling

To ensure the best results, store the product at a temperature between 20° to 25°C (68° to 77°F). Before using it, make sure to shake the bottle well to mix the contents thoroughly. When measuring your dose, always use the dosing cup provided, as it is specifically designed for this product. Avoid using this dosing cup with any other products to maintain safety and accuracy. Following these guidelines will help you use the product effectively and safely.

Additional Information

For adults and children aged 12 and older, the recommended dosage 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 exceeding 10 mL in 24 hours. 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. It is important to note that this medication should not be used in children under 4 years of age.

FAQ

What is Dextromethorphan Polistirex Extended-Release Oral Suspension?

It is a cough suppressant that provides 12 hours of cough relief in an orange-flavored, alcohol-free liquid.

How does Dextromethorphan work?

It temporarily relieves cough due to minor throat and bronchial irritation, helping you get to sleep.

What are the dosing instructions for adults?

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

What are the dosing instructions for children?

Children 6 to under 12 years should take 5 mL every 12 hours (max 10 mL in 24 hours), and children 4 to under 6 years should take 2.5 mL every 12 hours (max 5 mL in 24 hours).

Are there any contraindications for using this medication?

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 there an allergy alert for this medication?

Yes, it contains sodium metabisulfite, which may cause allergic-type reactions.

What should I do in case of overdose?

Get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Dextromethorphan?

Store it at 20° to 25°C (68° to 77°F).

Can I use this medication if I am pregnant or breastfeeding?

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

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 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 appropriate 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 alternative instructions provided by their physician.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for 2 weeks following the discontinuation of an MAOI. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

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

General Precautions Prior to 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

Dextromethorphan is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. The combination of dextromethorphan and an MAOI may lead to serious interactions, which can result in significant adverse effects. Therefore, it is essential to avoid the use of dextromethorphan in these circumstances to ensure patient safety. No additional drug or laboratory test interactions have been identified.

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

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the variability in pharmacokinetics and pharmacodynamics that can occur with aging.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, and specific interventions may be required based on the symptoms presented.

Management of an overdose may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, advanced interventions such as airway management, intravenous fluids, or antidotes may be indicated, depending on the specific agent involved.

It is crucial for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the latest evidence and clinical protocols.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, no information is provided concerning animal pharmacology and toxicology.

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 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, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. Healthcare providers should also 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 in a container that requires careful handling to ensure its integrity and effectiveness. It should be stored at a temperature range of 20° to 25°C (68° 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 measure only with the dosing cup provided with the product. The dosing cup should not be used with any other products to maintain its intended use and prevent cross-contamination.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 10 mL every 12 hours, with a maximum dosage of 20 mL within a 24-hour period. For children aged 6 to under 12 years, the recommended dose is 5 mL every 12 hours, not exceeding 10 mL in 24 hours. 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. The medication is not recommended for children under 4 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.

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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.