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Cough Relief

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Active ingredient
Dextromethorphan Hydrobromide 15 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
June 14, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 15 mg/5 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2016
Label revision date
June 14, 2024
Manufacturer
TOP CARE (Topco Associates LLC)
Registration number
M012
NDC root
36800-509
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

DExtromethorphan HBr 15 mg is a cough suppressant designed to provide relief from coughing caused by minor throat and bronchial irritation, which can occur with the common cold or from inhaled irritants. It works by temporarily reducing the urge to cough, helping you to get the rest you need, especially at night.

This medication is suitable for adults and children aged 6 and older, offering relief that lasts for 6 to 8 hours. It comes in a pleasant orange flavor 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 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

When taking this medication, it's important to follow the recommended dosage or your doctor's instructions. For adults and children aged 12 years and older, you should take 10 milliliters (mL) every 6 to 8 hours, but do not exceed 4 doses in a 24-hour period. If your child is between 6 and 11 years old, the dosage is 5 mL every 6 to 8 hours, also not exceeding 4 doses in a day. Please note that this medication is not suitable for children under 6 years of age.

To ensure accurate dosing, always use the dosing cup that comes with the product—do not use any other measuring device. Before each use, make sure to shake the bottle well. Keep the dosing cup with the product for easy access. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you should not use this product 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 before using this product.

It's also important to follow the dosage instructions carefully and not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Do not use it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks.

Before using this medication, consult your doctor if you have a chronic cough due to smoking, asthma, or emphysema, or if your cough is accompanied by excessive mucus. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these may indicate a more serious issue. In case of an overdose, it is crucial to get medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

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. 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, as these may indicate a more serious health issue.

In the event of an overdose, seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Your health and safety are important, so please take these precautions seriously.

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. For children aged 6 to 11 years, the recommended dosage is 5 mL every 6 to 8 hours, but you should not give more than 4 doses in a 24-hour period.

However, if your child is under 6 years old, you should avoid using this medication altogether. 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 available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always prioritize safety and open communication when it comes to managing health in later years.

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 (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.

Always consult with your healthcare provider or pharmacist if you're unsure whether your current medications include an MAOI. They can help ensure that your treatment is safe and effective.

Storage and Handling

To ensure the best results, store the product at room temperature, specifically between 20-25ºC (68º-77ºF). It's important not to refrigerate it. Always keep the dosing cup with the product for accurate measurement. Before using, make sure to shake the bottle well to mix the contents properly.

For your safety, check that the carton is unopened and that the printed safety seal around the bottle or under the cap is intact. If you find that the carton has been opened or the seal is broken or missing, do not use the product. Remember to discard any unused product after opening to maintain safety and effectiveness.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is Dextromethorphan HBr used for?

Dextromethorphan HBr is a cough suppressant that temporarily relieves cough due to minor throat and bronchial irritation, often caused by the common cold or inhaled irritants.

What is the recommended dosage for adults?

For adults and children 12 years and over, the recommended dosage is 10 mL every 6-8 hours, not to exceed 4 doses in 24 hours.

Can children use Dextromethorphan HBr?

Children aged 6 to 11 years can take 5 mL every 6-8 hours, not to exceed 4 doses in 24 hours. It is not recommended for children under 6 years of age.

What should I do if I experience an overdose?

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

Are there any contraindications for using this medication?

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

What should I do if my cough lasts more than 7 days?

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache, stop using the product and consult a doctor.

Is it safe to use Dextromethorphan HBr during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Dextromethorphan HBr.

How should I store Dextromethorphan HBr?

Store Dextromethorphan HBr between 20-25ºC (68º-77ºF) and do not refrigerate. Keep the dosing cup with the product.

Packaging Info

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

Packaging configurations for Cough Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dextromethorphan HBr is presented in a dosage form of 15 mg per unit. The formulation features an orange flavor and is packaged in fluid ounces (FL OZ) or milliliters (mL). A dosing cup is included to facilitate accurate administration. The product is tamper evident; it should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or as a result of inhaled irritants. Additionally, it is indicated for the temporary relief of the impulse to cough, facilitating sleep.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 10 mL administered every 6 to 8 hours, with a maximum of 4 doses within a 24-hour period. For children aged 6 to 11 years, the dosage is 5 mL every 6 to 8 hours, also not to exceed 4 doses in a 24-hour timeframe.

It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times. Prior to administration, the product must be shaken well to ensure proper mixing.

For children under 6 years of age, the product is not recommended for use.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product if they have a chronic cough associated with smoking, asthma, or emphysema, or if they experience a cough accompanied by excessive phlegm (mucus).

Patients are instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious warnings include the contraindication of use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease.

Patients are advised to consult a healthcare professional prior to use if they have a chronic cough that persists, particularly in cases related to smoking, asthma, or emphysema. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before using this medication.

It is crucial for patients to discontinue use and consult a healthcare provider if their cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, 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 (1-800-222-1222) should be contacted without delay.

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 Cough Relief (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cough Relief.
Details

Pediatric Use

Pediatric patients aged 6 to 11 years may receive a dosage of 5 mL every 6 to 8 hours, with a maximum of 4 doses within a 24-hour period. Use is not recommended for children under 6 years of age.

Geriatric Use

There is no specific information 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 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 at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or detailed nonclinical toxicology information available. Additionally, no specific animal pharmacology and toxicology details have been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 for patients to understand the importance of adhering to the prescribed dosage and to avoid using more than directed. This guidance is essential to ensure patient safety and to prevent potential adverse effects associated with misuse.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68º-77ºF) and to avoid refrigeration. Prior to use, the product must be shaken well.

To ensure safety, the product features a tamper-evident design; therefore, it should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. Additionally, the product should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cough Relief, 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 Relief, 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.

Learn more in our Editorial Policy

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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.