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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 2015
Label revision date
April 22, 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 2015
Label revision date
April 22, 2024
Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Registration number
M012
NDC root
63868-957
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 is a cough suppressant that helps relieve 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, making it easier for you to rest and sleep.

This medication is suitable for individuals aged 6 and over and provides relief for 6 to 8 hours. It is alcohol-free and comes in a pleasant orange flavor, making it a convenient option for managing cough symptoms without the addition of fever reducers or pain relievers.

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. It can also help reduce the urge to cough, making it easier for you to fall asleep.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

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 make sure not to exceed 4 doses in a 24-hour period. If you’re giving this medication to children aged 6 to 11 years, the dosage is 5 mL every 6 to 8 hours, also not exceeding 4 doses in a day.

For children under 6 years of age, this medication should not be used. Always measure the dosage using the dosing cup that comes with the product, as using any other device could lead to incorrect dosing. Remember to shake the bottle well before each use, and keep the dosing cup with the product for easy access.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.

While using this product, it’s important to follow the directions carefully and not exceed the recommended dosage. Misusing or taking more than directed can lead to serious health risks. 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. If you are unsure whether your medication contains an MAOI, consult your doctor or pharmacist.

If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and seek medical advice, as these could indicate a more serious issue. Additionally, consult your doctor before using this product if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough produces excessive mucus. In the event of an overdose, it is crucial to seek immediate medical assistance 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 or certain other conditions. If you have recently stopped taking an MAOI, wait at least two weeks before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to 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 a fever, rash, or persistent headache, stop using the product and contact your doctor, as these may be signs of a more serious issue.

In the event of an overdose, seek medical help immediately 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.

Don’t wait to see if symptoms improve; getting prompt medical attention can be vital. Always err on the side of caution when it comes to your health.

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, as it is not recommended for that age group.

Always ensure that you adhere to these age-specific guidelines to keep your child safe and healthy. If you have any questions or concerns about the medication, consult your healthcare provider for further advice.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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, 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 about your treatments.

Storage and Handling

To ensure the best results with your product, store it at room temperature, specifically between 20-25ºC (68-77ºF). It's important not to refrigerate it, as this can affect its effectiveness. 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 ensure 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 it. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for help.

FAQ

What is Dextromethorphan HBr used for?

Dextromethorphan HBr is a cough suppressant that temporarily relieves cough due to minor throat and bronchial irritation, as may occur with the common cold or inhaled irritants.

Who can use Dextromethorphan HBr?

This product is for ages 6 and over. Children under 6 years of age should not use it.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 10 mL every 6-8 hours, not exceeding 4 doses in 24 hours.

What should I do if I experience an overdose?

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

Are there any warnings associated with Dextromethorphan HBr?

Do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

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

Stop using the product and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache.

Is Dextromethorphan HBr safe to use during pregnancy or breastfeeding?

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

How should I store Dextromethorphan HBr?

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

What flavor does Dextromethorphan HBr come in?

Dextromethorphan HBr is available in an orange flavor.

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. This formulation is alcohol-free and features an orange flavor. It is important to note that this product does not contain any fever reducers or pain relievers.

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 to help alleviate the impulse to cough, thereby 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. 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 use of this product is not recommended.

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. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used in excess of the directed dosage.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before 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 provider 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 critical 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 this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication.

Patients are advised to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious underlying condition.

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

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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 includes an MAOI 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. The product is specifically labeled for use in children aged 6 years and older. It is contraindicated for use in children under 6 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 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. 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 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 drug. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential. Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific clinical presentation.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the severity of symptoms and the patient's medical history. Continuous monitoring and evaluation are critical components of effective overdose management.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

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.

Patients should be informed 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. Additionally, patients should 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 prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

It is important to remind patients to adhere strictly to the recommended dosage and not exceed the directed amount when using this product.

Patients should also be advised to consult a doctor before using this product if they have a chronic cough associated with smoking, asthma, or emphysema. Furthermore, they should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

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 20-25º C (68-77ºF) and to avoid refrigeration. Prior to use, the product must be shaken well.

To ensure safety and integrity, 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. In the event of an overdose, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. 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.