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Cough Relief

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This product has been discontinued

Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Dosage form
Capsule, Liquid Filled
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 2022
Label revision date
December 11, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M012
NDC root
68210-4240
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 medication primarily used for cough relief. It works by temporarily alleviating cough caused by minor irritation in the throat and bronchial tubes, which can happen during a cold. This makes it a helpful option for managing uncomfortable coughing that can disrupt your day-to-day activities.

Typically available in softgel form, Dextromethorphan HBr provides a convenient way to find relief when you need it most.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which can happen when you have a cold. It helps soothe your symptoms, making it easier for you to feel comfortable while you recover.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

You should take this medication carefully to ensure your safety and effectiveness. If you are an adult or a child aged 12 years and older, you can take 2 capsules every 6 to 8 hours as needed. However, make sure not to exceed 8 capsules in a 24-hour period.

It's important to note that this product is not suitable for children under 12 years of age, so please do not use it for younger children. Always follow these guidelines to help manage your symptoms safely.

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 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 important to follow these guidelines to prevent potential serious interactions and ensure your safety. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

Side Effects

You should be aware of some important warnings and potential side effects when considering this medication. Do not use it if you are currently taking a 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 have a cough that produces a lot of mucus or a chronic cough due to smoking, asthma, or emphysema, consult your doctor before using this product.

If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could indicate a more serious issue. Additionally, if you are pregnant or breastfeeding, it's important to talk to a healthcare professional before use. Always keep this medication out of reach of children, and in case of an overdose, contact medical help or a Poison Control Center immediately.

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. Additionally, 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 ask your doctor if you have a cough that produces a lot of mucus, or if your cough is chronic due to smoking, asthma, or emphysema. 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 be signs of a more serious issue. If you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep this product out of reach of children, and in case of an overdose, seek medical help immediately or contact a 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are 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

This product is specifically designed for adults and is not suitable for children under 12 years of age. If you have a child who is younger than 12, it is important to avoid using this medication for their safety. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

This product is designed for adults and is not suitable for children under 12 years old. If you are 12 years or older, you can take 2 capsules every 6 to 8 hours as needed.

For older adults, there are no specific dosage adjustments or safety concerns noted for this medication. However, it's always a good idea to consult with a healthcare provider to ensure that any medication is appropriate for your individual health needs.

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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. 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 and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid exposing it to excessive heat, which means keeping it below 40°C (104°F). Additionally, protect the product from light to maintain its integrity.

When handling the product, always do so with clean hands and in a clean environment to prevent contamination. Following these guidelines will help ensure the product remains safe and effective for your use.

Additional Information

You can take this medication orally, with both adults and children advised to take 2 capsules every 6 to 8 hours as needed. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Dextromethorphan HBr used for?

Dextromethorphan HBr is used for temporarily relieving cough due to minor throat and bronchial irritation, which may occur with a cold.

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

Adults and children 12 years and over should take 2 capsules every 6 to 8 hours, as needed, but do not exceed 8 capsules in a 24-hour period.

Is Dextromethorphan HBr safe for children under 12?

No, this product is not intended for use in children under 12 years of age.

Are there any contraindications for using Dextromethorphan HBr?

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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, stop use and consult a doctor.

Can I use Dextromethorphan HBr if I am pregnant or breastfeeding?

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

How should Dextromethorphan HBr be stored?

Store Dextromethorphan HBr at 20-25°C (68-77°F), avoid excessive heat above 40°C (104°F), and protect it from light.

What should I do in case of an overdose?

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

Packaging Info

Below are the non-prescription pack sizes of 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 an antitussive agent indicated for the relief of cough. Each softgel contains 15 mg of dextromethorphan hydrobromide. The product is available in a package containing 60 softgels.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 capsules every 6 to 8 hours as needed. It is important not to exceed a total of 8 capsules within a 24-hour period. This product is not intended for use in children under 12 years of age.

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.

Warnings and Precautions

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.

Prior to use, patients should seek medical advice if they have a cough that is associated with excessive phlegm (mucus) or if they experience a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Patients are advised to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may signal a more serious health issue.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

This product should be stored out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware of the following adverse reactions and important warnings associated with the use of this product.

The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional prior to use.

Patients should seek medical advice before using this product if they have a cough that is productive with excessive phlegm or if they have a chronic cough associated with smoking, asthma, or emphysema.

It is recommended that patients discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a healthcare professional before using this product. Furthermore, it is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made 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 disorders, emotional conditions, or Parkinson's disease. Patients should not initiate treatment with this product while currently taking an MAOI or within 2 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 using this product. This precaution is critical to avoid potential adverse interactions that may arise from the combination of these agents.

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

This product is not intended for use in pediatric patients under 12 years of age. There are no established safety or efficacy profiles for children in this age group, and therefore, it is contraindicated for use in this population.

Geriatric Use

Elderly patients may use this adult product, which is not intended for children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 capsules every 6 to 8 hours, as needed.

While there are no specific dosage adjustments or safety concerns noted for geriatric patients in the provided information, healthcare providers should exercise caution and monitor for any potential adverse effects, as the pharmacokinetics and pharmacodynamics may differ in this population. Regular assessment of the patient's response to treatment is advisable to ensure safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 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 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 without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures 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 mitigate any adverse effects associated with the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be advised to seek medical advice before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its efficacy and stability.

Additional Clinical Information

The medication is administered orally, with both adults and children instructed to take 2 capsules every 6 to 8 hours as needed. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.