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Dextromethorphan hydrobromide

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Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2024
Label revision date
January 12, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dextromethorphan Hydrobromide 15 mg
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2024
Label revision date
January 12, 2026
Manufacturer
Softgel Healthcare Pvt Ltd
Registration number
M012
NDC root
35916-0461
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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 Hydrobromide is a medication that temporarily relieves cough caused by minor irritation in the throat and bronchial tubes, which can happen during a cold. It helps to soothe your throat and reduce the urge to cough, making it easier for you to feel more comfortable.

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.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing your cough during a cold.

Dosage and Administration

You should be careful when taking this medication. Adults and children aged 12 years and older can take 2 capsules every 6 to 8 hours as needed, but make sure not to exceed 8 capsules in a 24-hour period. This means you can take the capsules throughout the day, but always keep track of how many you've taken to avoid taking too much.

It's important to note that this product is not intended for children under 12 years of age, so if you're considering it for a younger child, you should not use it. Always follow these guidelines to ensure safe and effective use of the medication.

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 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, it's important to consult with your doctor or pharmacist before using this product.

Taking this precaution is crucial to prevent serious interactions and ensure your safety. Always prioritize your health by checking with a healthcare professional if you have any doubts about your medications.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it’s important to stop using the medication and consult a doctor, as these symptoms could indicate a serious condition.

Before using this medication, you should also speak with your doctor if you have a cough that produces a lot of phlegm (mucus) or if you have a chronic cough related to smoking, asthma, or emphysema.

Warnings and Precautions

It's important to be cautious when using this medication. Do not take it if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. You should also avoid this medication for at least two weeks after stopping an MAOI. If you're unsure whether your current medication includes an MAOI, please consult your doctor or pharmacist.

If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, you should stop using this medication and call your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

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 should not be used in children under 12 years of age. If your child is younger than 12, it’s important to avoid using this medication altogether. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

If you are an older adult or caring for one, it's important to know that this medication is not suitable for children under 12 years old. Before using it, you should consult a doctor if you have a cough that produces a lot of mucus or if your cough is chronic, which can happen with conditions like smoking, asthma, or emphysema.

Additionally, if your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, you should stop using the medication and seek medical advice. These symptoms could indicate a more serious health issue that needs attention.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests, which help assess how well your kidneys are working. If your creatinine clearance (a measure of kidney function) falls below a specific level, a reduced dose of your medication may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to ensure your safety and the effectiveness of your treatment. Always discuss any concerns with your healthcare provider to ensure the best care for your condition.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to be cautious when taking dextromethorphan, especially if you are also using monoamine oxidase inhibitors (MAOIs), which are a type of medication used to treat certain mental health conditions. Using dextromethorphan while on MAOIs can lead to serious interactions, so you should avoid this combination during MAOI therapy and for at least two weeks after stopping MAOIs.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and to avoid potential interactions. This conversation is crucial for managing your health effectively.

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, particularly temperatures above 40°C (104°F), as this can compromise its effectiveness. Additionally, keep the product protected from light to maintain its quality.

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

Additional Information

No further information is available.

FAQ

What is Dextromethorphan Hydrobromide used for?

Dextromethorphan Hydrobromide temporarily relieves cough due to minor throat and bronchial irritation, which may occur with a cold.

Who should not use this product?

This product is not intended for use in children under 12 years of age. Additionally, do not use if you are currently taking a monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

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.

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

Stop use and ask a doctor if your cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, as these could be signs of a serious condition.

What precautions should I take if I have a chronic cough?

Ask a doctor before use if you have a cough that occurs with too much phlegm (mucus) or a chronic cough due to smoking, asthma, or emphysema.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

Is it safe to use Dextromethorphan if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store Dextromethorphan Hydrobromide?

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

Packaging Info

Below are the non-prescription pack sizes of Dextromethorphan Hydrobromide. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dextromethorphan Hydrobromide.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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

The use of this product necessitates careful consideration of specific warnings and precautions to ensure patient safety.

Warnings 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, it is contraindicated for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm whether a patient’s current prescription includes an MAOI by consulting with the patient or their pharmacist.

General Precautions In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Monitoring and Follow-Up Patients should be advised to discontinue use and consult a healthcare provider if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Side Effects

Patients should be 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 a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, it is important for patients to seek medical advice prior to use if they have a cough associated with excessive phlegm (mucus) or if they experience a chronic cough, which may be related to smoking, asthma, or emphysema.

Drug Interactions

Dextromethorphan is contraindicated for use in conjunction with monoamine oxidase inhibitors (MAOIs) due to the potential for serious interactions. This contraindication extends to the duration of MAOI therapy and for a period of 2 weeks following the discontinuation of MAOIs. It is essential to avoid co-administration to mitigate the risk of adverse effects associated with this combination.

No additional drug interactions or laboratory test interactions have been identified for dextromethorphan. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Dextromethorphan Hydrobromide. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dextromethorphan Hydrobromide.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

Elderly patients should be aware that this adult product is not intended for use in individuals under 12 years of age. It is advisable for geriatric patients to consult a healthcare provider prior to use if they experience a cough that is associated with excessive phlegm (mucus) or if the cough is chronic, as may occur with conditions such as smoking, asthma, or emphysema.

In the event that a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, elderly patients should discontinue use and seek medical advice. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation. Careful monitoring and appropriate medical consultation are essential for ensuring the safety and well-being of geriatric patients using this product.

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 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. For patients with a creatinine clearance below a certain threshold, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, respiratory depression, serotonin syndrome, and allergic reactions such as rash, pruritus, and angioedema.

The frequency of these adverse reactions is not known, and it is important to note that these reactions may not be directly related to the use of the product. Additional safety information may be obtained from the manufacturer.

Patient Counseling

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

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 essential for patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should also 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 encouraged to seek medical advice before using the medication if they have a cough that produces excessive phlegm 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

No further data are available.

Drug Information (PDF)

This file contains official product information for Dextromethorphan Hydrobromide, 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 Dextromethorphan Hydrobromide, 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.