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Equate 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 2015
Label revision date
July 8, 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 2015
Label revision date
July 8, 2020
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA091135
NDC root
49035-899
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 that contains dextromethorphan polistirex, designed to provide temporary relief from coughs caused by minor throat and bronchial irritation, such as those associated with the common cold or inhaled irritants. This medication works by reducing the urge to cough, which can help you get a better night's sleep.

Suitable for both children and adults aged 4 years and older, COUGH DM offers 12-hour cough relief and is alcohol-free. It comes in a grape-flavored liquid form, making it easier to take, and includes a dosing cup for convenience.

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 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 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 or emotional conditions, or Parkinson’s disease. Additionally, you must wait at least two weeks after stopping an MAOI before using this product. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist for clarification. It's important to follow these guidelines to ensure your safety and well-being.

Side Effects

You may experience side effects while using this medication. It's important to be aware that if your cough 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 advice.

If you have a chronic cough related to smoking, asthma, or emphysema, or if your cough produces excessive mucus, consult your doctor before using this medication. Remember, you can report any side effects 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 use it if you are currently taking 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 are 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 contact your doctor if you experience any side effects, if your cough lasts more than seven days, or if your cough returns with 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. If you have a chronic cough due to smoking, asthma, or emphysema, or if your cough is accompanied by excessive mucus, please consult your doctor before using this product.

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 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 make sure not to 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, so avoid using it for younger children. Always consult with your healthcare provider if you have any questions or concerns about your child's medication.

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 ensure that your healthcare provider is aware of any existing health conditions or medications, as this can help in making informed decisions about treatment options. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. To ensure your safety, your healthcare provider will monitor your renal function regularly, especially by checking your creatinine clearance levels (a measure of kidney function).

Before starting any new treatment, you should have renal function tests done, and these tests should continue periodically throughout your therapy. If you have severe renal impairment, your doctor will take special care to adjust your dosage appropriately to avoid any potential complications. Always communicate openly with your healthcare team about your kidney health.

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. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

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 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 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 health concerns. 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 and adults aged 4 years and older.

How does COUGH DM work?

It relieves the impulse to cough, helping you get to sleep and providing 12-hour cough relief.

What are the dosing instructions for COUGH DM?

Adults and children 12 years and older should take 10 mL every 12 hours, while children 6 to under 12 years should take 5 mL, and children 4 to under 6 years should take 2.5 mL every 12 hours.

Are there any contraindications for COUGH DM?

Do not use COUGH DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last 2 weeks.

What should I do if I experience side effects?

You should report side effects to the FDA at 1-800-FDA-1088 and consult a doctor if symptoms persist or worsen.

Can I use COUGH DM if I am pregnant or breastfeeding?

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

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.

What are the storage instructions for COUGH DM?

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

Does COUGH DM contain any allergens?

Yes, COUGH DM contains sodium metabisulfite, which may cause allergic-type reactions.

Packaging Info

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

Packaging configurations for Equate Cough Dm.
Details

Drug Information (PDF)

This file contains official product information for Equate 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 use in children and adults aged 4 years and older. This preparation provides 12 hours of cough relief and is presented as a grape-flavored liquid. The product is alcohol-free and comes in a 5 fluid ounce (148 mL) container, which includes a dosing cup for accurate administration. It contains sodium metabisulfite, a sulfite that may elicit 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 each use. Dosing must be measured exclusively with the dosing cup provided; the use of this cup with other products is not recommended.

For dosing, the following guidelines should be adhered to, unless otherwise 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.

It is essential to follow these dosing instructions carefully to ensure safety and efficacy.

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 medication contains an MAOI.

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. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is recommended.

Patients should be aware of the Allergy Alert: 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 a headache that lasts, these may indicate a serious underlying condition requiring medical evaluation.

General precautions should be taken prior to use. Individuals with a chronic cough lasting due to smoking, asthma, or emphysema should consult a healthcare provider before using this product. Furthermore, those experiencing a cough associated with excessive phlegm (mucus) should also seek medical advice prior to use.

No specific laboratory tests are recommended for the safe use of this product.

Side Effects

Patients may experience side effects while using this medication. It is important to report any adverse reactions to the FDA at 1-800-FDA-1088.

In clinical practice, patients should be advised to stop use and consult a healthcare professional if they experience persistent cough lasting more than 7 days, or if the cough recurs, particularly if accompanied by fever, rash, or headache. These symptoms may indicate a serious underlying condition that requires medical attention.

Additionally, patients with a chronic cough associated with smoking, asthma, or emphysema should seek medical advice before using this product. Coughs that are accompanied by excessive phlegm (mucus) also warrant consultation with a healthcare provider prior to use.

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, 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 Equate Cough Dm (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Equate 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.

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 lactation. 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 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 dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, ensuring that appropriate modifications are made to optimize therapeutic outcomes. Special consideration is warranted for patients with severe renal impairment, as they may require more stringent monitoring and adjustments. Renal function tests should be performed prior to initiating therapy and periodically thereafter to assess any changes in kidney function that may impact treatment.

Hepatic Impairment

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

Overdosage

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

It is essential to monitor the patient closely for any potential symptoms that may arise, as the lack of detailed overdosage data does not preclude the possibility of adverse effects. Symptoms may vary depending on the individual and the circumstances surrounding the overdose.

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

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on managing overdose situations effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

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

Additionally, the product contains sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

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 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 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 advise patients to consult a doctor prior to use if they have any underlying health conditions. 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 immediate medical assistance or contact a Poison Control Center 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 Equate 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 Equate 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.