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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 2013
Label revision date
December 9, 2019
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
December 9, 2019
Manufacturer
American Sales Company
Registration number
ANDA091135
NDC root
41520-958
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 a cough suppressant in the form of an orange-flavored liquid that contains dextromethorphan polistirex. 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 sleep, and provides relief for up to 12 hours.

Suitable for both children aged 4 and older and adults, COUGH DM is alcohol-free and comes with a dosing cup for easy measurement. It can be taken day or night, making it a convenient option for managing cough symptoms.

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; avoid using it with any other products to ensure accuracy.

For adults and children aged 12 and older, 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 suitable 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 conditions, or Parkinson’s disease. Additionally, you should not take this medication 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.

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 not use this medication. Always prioritize your safety and consult a healthcare professional if you have any concerns.

Side Effects

You should be aware that this medication contains sodium metabisulfite, which can cause allergic reactions in some individuals. If you experience any side effects, it's important to stop using the medication and consult your doctor. Additionally, if your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, these could be signs of a more serious condition, and you should seek medical attention.

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, certain psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you are unsure whether your medication contains an MAOI, please consult your doctor or pharmacist. 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 a persistent headache, stop using the product and contact your doctor. These symptoms could indicate a more serious health issue. In the event of an overdose, seek emergency medical assistance immediately or call the 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 a possible overdose, 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 giving this medication to your child, it's important to follow the recommended dosages based on their age. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, but you should not exceed 10 mL in a 24-hour period. If your child is between 4 and under 6 years old, the dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours.

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

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you are caring for an older adult, be attentive to any changes in their health or behavior after starting a new medication. Regular check-ins with a healthcare professional can help manage any potential risks and ensure the best outcomes.

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 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 determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

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

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious 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 performance of your product, store it 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 or damage. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. Before using it, consult your doctor if you have any allergies or are currently taking other medications. If you are pregnant or breastfeeding, it's important to speak with a healthcare professional first. Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is COUGH DM?

COUGH DM is a dextromethorphan polistirex extended-release oral suspension that temporarily relieves cough due to minor throat and bronchial irritation.

Who can use COUGH DM?

COUGH DM is for children aged 4 and older, as well as adults.

How does COUGH DM work?

It helps relieve the impulse to cough, which can assist with sleep and alleviate cough caused by the common cold or inhaled irritants.

What is the recommended dosage for adults?

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

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.

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 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 COUGH DM safe for pregnant or breastfeeding women?

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

What is the allergy alert for 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 a temperature between 20° to 25°C (68° to 77°F).

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 Extended-Release Oral Suspension is a cough suppressant formulated for extended-release delivery. This preparation is presented as an orange-flavored liquid, contained in a 3 FL OZ (89 mL) bottle. The formulation includes sodium metabisulfite, which is a sulfite that may elicit allergic-type reactions in susceptible 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; using the dosing 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. This includes certain medications 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.

Additionally, this product should not be used by individuals with a known allergy to sodium metabisulfite, as it may cause allergic-type reactions.

Warnings and Precautions

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be aware of the Allergy Alert associated with this product, as it contains sodium metabisulfite, a sulfite that may provoke 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, patients should seek medical attention, as these symptoms may indicate a serious underlying condition.

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.

Side Effects

Patients may experience adverse reactions associated with the use of this medication. Notably, there is an Allergy Alert due to the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any side effects occur. It is important to report these side effects to the FDA at 1-800-FDA-1088. Additionally, patients should seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, as these symptoms may indicate a serious underlying condition.

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, 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 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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution 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 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a healthcare 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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. Healthcare professionals are advised to contact a Poison Control Center without delay. The national hotline for poison control is 1-800-222-1222, which provides access to expert guidance in managing overdose situations.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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 additional relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

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.

Patients should be informed of the Allergy Alert regarding the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

It is important for patients to understand that they should discontinue use and consult a doctor if they experience any side effects. Additionally, patients are encouraged to report side effects to the FDA at 1-800-FDA-1088.

Healthcare providers should instruct patients to stop use and seek medical advice if a cough persists for more than 7 days, returns after improvement, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

Patients should also be advised to consult a doctor prior to use if they have a chronic cough associated with smoking, asthma, or emphysema. Furthermore, it is essential to ask a healthcare professional before use if the 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 advise patients to consult a doctor prior to use if they have any allergies or are currently taking other medications. Pregnant or breastfeeding patients are also encouraged to seek guidance from a health professional before use. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately 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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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.