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Cough Dm

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Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
January 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 30 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
January 20, 2025
Manufacturer
Rite Aid Corporation
Registration number
ANDA091135
NDC root
11822-0958
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

CHILDREN’S COUGH DM is an extended-release oral suspension that contains dextromethorphan polistirex, a cough suppressant designed to provide relief from coughing. This medication is specifically formulated to temporarily relieve cough caused by minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. It helps reduce the urge to cough, making it easier for you or your child to get a good night's sleep.

This orange-flavored liquid is suitable for children aged 4 and older and is alcohol-free and gluten-free. With a dosage cup included, it offers convenient dosing for both day and night use, providing up to 12 hours of cough relief.

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 your cough is keeping you awake at night, this medication can help reduce the urge to cough, allowing you to get a better night's sleep.

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, 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 note that this medication is not recommended for children under 4 years of age. Always follow your doctor’s instructions if they differ from these guidelines.

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 this product for at least two weeks after stopping an MAOI. If you are unsure whether your prescription includes 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. If you have a known allergy to sulfites, you should avoid using this product as well.

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 promptly.

For any side effects you encounter, you can report them 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 individuals.

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 it comes to using this medication for children, it's important to follow specific guidelines based on their age. For 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 those between 6 and 12 years old, the dose is reduced to 5 mL every 12 hours, not exceeding 10 mL in a day.

For younger 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. However, this medication should not be used in children under 4 years of age. 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 dosage adjustments or safety concerns noted. This means that, generally, you can expect the same dosage to be appropriate for elderly patients as it is for younger adults. However, it's always important to consult with a healthcare provider to ensure that the medication is suitable 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 about medications and their effects is crucial. Always discuss any concerns with a healthcare professional 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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

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 crucial to be aware of potential interactions when taking medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease, you should not take this product. Additionally, you need to wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid harmful interactions. Your health and well-being are the top priority, so don't hesitate to ask questions about your treatments.

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 CHILDREN’S COUGH DM?

CHILDREN’S COUGH DM is an extended-release oral suspension containing Dextromethorphan Polistirex, which acts as a cough suppressant providing 12 hours of cough relief.

What age group can use CHILDREN’S COUGH DM?

This medication is suitable for children aged 4 and older.

How should I measure the dosage?

Use the dosing cup provided to measure the dosage accurately; do not use it with other products.

What are the recommended dosages for different age groups?

For children 12 years and older, the dose is 10 mL every 12 hours. For children 6 to under 12 years, it's 5 mL every 12 hours. For children 4 to under 6 years, it's 2.5 mL every 12 hours. Do not use for children under 4 years.

What should I do if I experience side effects?

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

Are there any contraindications for using CHILDREN’S COUGH DM?

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

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.

Is CHILDREN’S COUGH DM safe during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this product.

What are the storage conditions for CHILDREN’S COUGH DM?

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

What is the allergy alert for CHILDREN’S COUGH DM?

This product contains sodium metabisulfite, which may cause allergic-type reactions in some individuals.

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

This product is an alcohol-free, gluten-free oral suspension formulated for cough relief, suitable for children aged 4 years and older as well as adults. It contains dextromethorphan polistirex as the active ingredient, providing extended-release cough suppression for up to 12 hours. The formulation is presented as an orange-flavored liquid, packaged in a 3 fluid ounce (89 mL) bottle, and includes a dosage cup for accurate measurement. It is important to note that the product contains sodium metabisulfite, which may trigger allergic-type reactions in sensitive individuals.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It also serves to alleviate the impulse to cough, thereby 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 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 a 24-hour period. This product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that patients adhere to these dosing guidelines or follow any specific instructions provided by their physician.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should consult a healthcare professional if uncertain whether their prescription includes 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. 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 for allergic reactions associated with the use of this product, as it contains sodium metabisulfite, a sulfite known to cause allergic-type reactions in some individuals.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any side effects occur. Additionally, 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 that requires medical attention.

Patients are encouraged to report any side effects to the FDA at 1-800-FDA-1088 to contribute to ongoing safety monitoring.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

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 12 years and older may be administered 10 mL every 12 hours, with a maximum dosage 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 to exceed 10 mL in 24 hours. In 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. Use is not recommended in children under 4 years of age.

Geriatric Use

Elderly patients may not require specific dosage adjustments when using this medication, as there are no safety concerns or dosage modifications indicated in the available data. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with pharmacotherapy in geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

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 maternal health. 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 currently no available data regarding 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 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 drug. 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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has indicated that side effects may occur following the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088. Reports received are considered voluntary and contribute to ongoing surveillance efforts.

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 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. It is also important for healthcare providers to 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 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 are advised to consult a healthcare professional prior to use. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center can be contacted at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, 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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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.