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Cvs 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 2013
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
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 2013
Label revision date
September 8, 2025
Manufacturer
Sixarp, LLC
Registration number
ANDA091135
NDC root
59368-250
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

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 rest and sleep, whether during the day or at night.

This orange-flavored liquid is suitable for both children and adults aged 4 and older, providing up to 12 hours of cough relief. 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 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 medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, you should not use it for at least two weeks after stopping an MAOI.

Be aware that this medication 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 medication. Always consult with your healthcare provider if you have any questions or concerns about your medications.

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. 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 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

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 considering this medication for 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, with a maximum of 10 mL in a 24-hour period. If your child is between 4 and under 6 years old, they should take 2.5 mL every 12 hours, not exceeding 5 mL in a day.

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

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 used for younger adults may also be appropriate for older patients. However, it’s always important to consult with a healthcare provider to ensure that the medication is safe and effective for your individual health needs.

As you or your loved ones age, it’s crucial to monitor any changes in health or how the medication is working. If you notice any unusual side effects or if there are changes in health conditions, be sure to discuss these with a doctor. They can provide guidance tailored to the specific needs of older adults.

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 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, or within two weeks of stopping them, can lead to serious interactions that may affect your health.

Always discuss any medications you are taking with your healthcare provider to ensure they are safe to use together. This conversation is crucial for your safety and to avoid any potential complications.

Storage and Handling

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

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

Additional Information

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

FAQ

What is Dextromethorphan Polistirex Extended-Release Oral Suspension used for?

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

Who can use this medication?

It is indicated for use in children and adults aged 4 years and older.

How should I take Dextromethorphan Polistirex?

Shake the bottle well before use and measure with the dosing cup provided. Adults and children 12 years and over should take 10 mL every 12 hours, while younger children have different dosing guidelines.

Are there any contraindications for this medication?

Do not use if you are currently 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 an overdose?

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

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

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

What is the flavor of this medication?

It is an orange-flavored liquid.

How should I store Dextromethorphan Polistirex?

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

Packaging Info

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

Packaging configurations for Cvs Cough Dm.
Details

Drug Information (PDF)

This file contains official product information for Cvs 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 dosing cup should not be used with any other products to ensure accurate measurement.

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

Healthcare professionals should advise patients to follow these dosing instructions or any alternative dosing as directed by their physician.

Contraindications

Use is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for 2 weeks following the discontinuation of an MAOI.

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

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. Additionally, it is contraindicated for use within 2 weeks after discontinuing 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.

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 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 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 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 MAOIs to mitigate the risk of adverse effects.

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

Packaging & NDC

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

Packaging configurations for Cvs Cough Dm.
Details

Pediatric Use

Pediatric patients aged 4 years and older are indicated for use of the product. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 12 hours, with a maximum of 10 mL in a 24-hour period. For children aged 4 to under 6 years, the dosage is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. The product is not recommended for use in 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 general considerations associated with aging and polypharmacy.

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 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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous assessment and monitoring of vital signs are recommended to ensure patient safety and to guide further therapeutic interventions.

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 that side effects may occur 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, or a cough that recurs or is 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 with a dosing cup included for accurate measurement. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for maintaining the integrity of the product.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Cvs 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 Cvs Cough Dm, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.