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Careone 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 2012
Label revision date
July 1, 2020
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 2012
Label revision date
July 1, 2020
Manufacturer
American Sales Company
Registration number
ANDA091135
NDC root
41520-384
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

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

With its 12-hour cough relief, COUGH DM can be used both day and night, and it comes in a pleasant orange flavor. It is alcohol-free and includes 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 rest more comfortably.

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

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. It's important to measure your dose using only the dosing cup that comes with the product, as using it with other products can lead to incorrect dosing.

For adults and children aged 12 and 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, certain psychiatric conditions, or Parkinson’s disease. Additionally, do not use it for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before using this product.

Be aware that this product contains sodium metabisulfite, which can cause allergic reactions in some individuals. If you experience any side effects, or if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or headache, stop using the product and consult your doctor. You can also report side effects to the FDA at 1-800-FDA-1088.

Side Effects

You may experience side effects while using this medication. It's important to be aware that 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, and you should seek medical attention.

Additionally, if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough produces excessive mucus, these are also important to discuss with your healthcare provider. If you notice any side effects, you can report them to the FDA at 1-800-FDA-1088.

Warnings and Precautions

If you are considering using this medication, please be aware of some important warnings. Do not take it 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 people.

You should stop using this medication and call 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 issue. In case of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. No specific lab tests are required for safe use of this medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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.

Please note that this medication is not recommended for children under 4 years of age. Always consult with your child's healthcare provider if you have any questions or concerns about their treatment.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of the medication. Before starting treatment, your healthcare provider will assess your creatinine clearance (a test that measures how well your kidneys are filtering waste). Regular tests to monitor your kidney function are also recommended to ensure your safety while on this medication. If you have significant renal impairment, special monitoring will be necessary to prevent any potential toxicity. Always discuss your kidney health with your doctor 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.

Your healthcare provider will likely monitor your liver function tests (which are blood tests that check how well your liver is working) to keep an eye on your liver health while you are taking the medication. Always use caution and discuss any concerns with your doctor when starting a new treatment, as they will guide you on the best approach for your specific situation.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson’s disease, you should not use this product. Additionally, you should 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 potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.

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, make sure to shake the bottle well to mix the contents thoroughly. When measuring your dose, always use the dosing cup provided, as using it with other products can lead to inaccurate dosing and potential safety issues.

By following these simple steps, you can safely handle and store the product, ensuring its effectiveness and your well-being.

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 COUGH DM?

COUGH DM is an extended-release oral suspension containing Dextromethorphan Polistirex, used to temporarily relieve cough due to minor throat and bronchial irritation.

How does COUGH DM work?

It temporarily relieves cough by suppressing the impulse to cough, helping you get to sleep.

What are the dosing instructions for adults?

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

Can children use COUGH DM?

Yes, but specific dosing varies: children 6 to under 12 years should take 5 mL every 12 hours, and those 4 to under 6 years should take 2.5 mL every 12 hours. Do not use in children under 4 years.

Are there any contraindications for using COUGH DM?

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

What should I do if I experience side effects?

If side effects occur, stop using COUGH DM and consult a doctor. You can report side effects to the FDA at 1-800-FDA-1088.

Is COUGH DM safe during pregnancy or breastfeeding?

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

What should I know about allergies related to COUGH DM?

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

How should I store COUGH DM?

Store COUGH DM at 20° to 25°C (68° to 77°F) and shake the bottle well before use.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Careone Cough Dm.
Details

Drug Information (PDF)

This file contains official product information for Careone Cough Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Dextromethorphan Polistirex is an extended-release oral suspension formulated as a cough suppressant. This preparation provides cough relief for up to 12 hours, making it suitable for use both day and night. The product is alcohol-free and is presented as an orange-flavored liquid, contained in a 3 FL OZ (89 mL) bottle. A dosing cup is included for accurate administration. It is important to note that this formulation contains sodium metabisulfite, which is a sulfite that may trigger allergic-type reactions in sensitive individuals.

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. It also serves to relieve 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 appropriate dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. This product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise patients to follow these dosing guidelines or 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 such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

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

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. It is also advised not to use this product for at least two weeks following the cessation of an MAOI. Healthcare professionals should confirm whether any prescribed medication contains an MAOI by consulting with a doctor or pharmacist.

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

No specific laboratory tests are required or suggested for the safe use of this product.

Side Effects

Patients may experience various adverse reactions while using this medication. It is important to monitor for serious symptoms, such as a cough that persists for more than 7 days, a cough that recurs, or a cough accompanied by fever, rash, or headache, as these may indicate a serious underlying condition.

In addition to these serious reactions, patients may also report chronic cough associated with conditions such as smoking, asthma, or emphysema. Furthermore, a cough that occurs with excessive phlegm (mucus) has been noted among participants.

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 minimum 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, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Careone Cough Dm.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL every 12 hours, with a maximum dosage of 10 mL in a 24-hour period. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. The use of this medication is not recommended for children under 4 years of age.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. 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 may necessitate a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating potential dosage adjustments. It is essential to monitor liver function tests in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. The product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in sensitive individuals.

No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

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.

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 at least 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 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, 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 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

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 contacted at 1-800-222-1222.

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

Drug Information (PDF)

This file contains official product information for Careone 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 Careone 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.