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Cough Dm

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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
59368-261
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 help relieve coughing caused by minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. This medication works by temporarily reducing the urge to cough, making it easier for you to get to sleep.

This grape-flavored liquid provides up to 12 hours of cough relief and is suitable for both day and night use. It is alcohol-free and comes with a dosing cup for your convenience.

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 get a better night's rest.

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 do not take more than 20 mL in a 24-hour period. If your child is between 6 and 12 years old, they should take 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 note that this medication is not recommended 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 or emotional 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 taking 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 may experience side effects while using this medication. It's important to report any side effects to the FDA at 1-800-FDA-1088. If you have a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could be signs of a more serious condition that requires medical attention.

Additionally, if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough produces excessive phlegm (mucus), you should consult your healthcare provider.

Warnings and Precautions

If you are considering using this medication, please be aware of some important warnings. Do not take this product if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication 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, consult your doctor or pharmacist. Additionally, this product contains sodium metabisulfite, which can cause allergic reactions in some individuals.

You should stop using this medication and contact your doctor 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, as these may indicate a more serious health issue. In the event of an overdose, seek medical help immediately or call the 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’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. 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.

If your child is under 4 years old, this medication should not be used at all. Always ensure you adhere to these guidelines to keep your child safe and healthy.

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 or your loved ones age, staying informed and discussing any concerns with a doctor can help ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your kidney function regularly, especially through tests that measure creatinine clearance (a way to assess how well your kidneys are filtering waste). If you have moderate to severe renal impairment, you might require a lower dose of your medication.

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety and the effectiveness of the therapy. Always communicate with your healthcare team about your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) while you are taking this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's important to be cautious when taking dextromethorphan, especially if you are also using monoamine oxidase inhibitors (MAOIs), which are a type of medication used to treat certain mental health conditions. Using dextromethorphan while on MAOIs can lead to serious interactions, so you should avoid taking dextromethorphan during MAOI therapy and for at least two weeks after stopping the MAOI.

Since there are no other specific drug interactions or laboratory test interactions noted, it's still essential to discuss all medications and any tests you may be undergoing with your healthcare provider. This ensures your safety and helps prevent any potential issues with your treatment. Always keep your healthcare team informed about what you are taking.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should take this medication according to the following guidelines: For adults and children aged 12 and over, the recommended dose is 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. For children aged 4 to under 6 years, the dose is 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 your 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 Dextromethorphan Polistirex Extended-Release Oral Suspension used for?

It is a cough suppressant that temporarily relieves cough due to minor throat and bronchial irritation, as may occur with the common cold or inhaled irritants.

How should I take Dextromethorphan Polistirex?

Shake the bottle well before use and measure only with the dosing cup provided. Adults and children 12 years and over should take 10 mL every 12 hours, not exceeding 20 mL in 24 hours.

Are there any age restrictions for using this medication?

Do not use this medication in children under 4 years of age. For children 4 to under 6 years, the dose is 2.5 mL every 12 hours, and for children 6 to under 12 years, it is 5 mL every 12 hours.

What should I do if I experience side effects?

If side effects occur, stop use and ask a doctor. You can report side effects to the FDA at 1-800-FDA-1088.

Can I use Dextromethorphan Polistirex if I am taking other medications?

Do not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

Is it safe to use Dextromethorphan Polistirex during pregnancy or breastfeeding?

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

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 are the storage conditions for this medication?

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

What is the flavor of Dextromethorphan Polistirex?

It is available in a grape-flavored liquid.

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

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache, stop use and ask a doctor, as these could be signs of a serious condition.

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 each use. Dosing must be measured exclusively with the dosing cup provided; the use of this cup with other products is not recommended.

For dosing, the following guidelines should be adhered to, or as directed by a healthcare professional:

Adults and Children 12 Years of Age and Over: Administer 10 mL every 12 hours, with a maximum dosage of 20 mL within a 24-hour period.

Children 6 to Under 12 Years of Age: Administer 5 mL every 12 hours, with a maximum dosage of 10 mL within a 24-hour period.

Children 4 to Under 6 Years of Age: Administer 2.5 mL every 12 hours, with a maximum dosage of 5 mL within a 24-hour period.

Children Under 4 Years of Age: The product is not recommended for use in this age group.

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. MAOIs are commonly 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 medication.

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

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

This product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Patients should be aware of the Allergy Alert, as this product contains sodium metabisulfite, a sulfite that may trigger allergic-type reactions in susceptible individuals.

Patients are advised 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 headache that lasts, it may indicate a serious underlying condition, and medical advice should be sought promptly.

In case of overdose, it is imperative to obtain emergency medical help or contact the Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients may experience various adverse reactions associated with the use of this medication. It is important to note that side effects can occur, and patients are encouraged to report any adverse reactions to the FDA at 1-800-FDA-1088.

Serious adverse reactions may include a persistent cough that lasts more than 7 days, a cough that recurs, or a cough accompanied by fever, rash, or headache. These symptoms could indicate a serious underlying condition that requires medical attention.

Common adverse reactions reported include chronic cough, particularly in patients with a history of smoking, asthma, or emphysema. Additionally, some patients may experience a cough that is associated with excessive phlegm (mucus).

Patients should be vigilant for these symptoms and consult healthcare professionals if they arise, as they may necessitate further evaluation and management.

Drug Interactions

Dextromethorphan is contraindicated for use in conjunction with monoamine oxidase inhibitors (MAOIs) due to the potential for serious interactions. It is advised to avoid the use of dextromethorphan during MAOI therapy and for a period of 2 weeks following the discontinuation of the MAOI to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been identified for dextromethorphan.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Additionally, renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate management of the patient's condition.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to guide further management.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide clear instructions on what to do in the event of a suspected overdose.

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 specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

Postmarketing experience has identified various side effects associated with the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

Additionally, it has been noted that a cough persisting for more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or headache may indicate the presence of 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.

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 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 in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

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

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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.