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Bupropidex

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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
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 6, 2025
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
Tablet
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 2023
Label revision date
October 6, 2025
Manufacturer
DXM Pharmacuetical, Inc.
Registration number
M013
NDC root
71598-200
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

This medication is designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes, which can happen with conditions like the common cold. It helps soothe your throat and reduce the urge to cough, making you feel more comfortable during your recovery.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens with the common cold. This means that if you're feeling uncomfortable due to a cough associated with a cold, this medication may help ease that symptom.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

It's important to use this medication exactly as directed by your doctor or according to the instructions provided. For adults and children aged 12 years and older, you can take 2 tablets every 6 to 8 hours as needed, but make sure not to exceed 8 tablets in a 24-hour period.

If you have children under 12 years of age, please do not use this product for them, as it is not intended for that age group. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should avoid using this medication if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of drug 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 cough that produces a lot of mucus or if you have a chronic cough due to smoking, asthma, or emphysema.

If your cough lasts more than a week, keeps coming back, 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. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately 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. 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 talk to your doctor if you have a cough that produces a lot of mucus or if you have a chronic cough due to smoking, asthma, or emphysema. If your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these could be signs of a more serious issue.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Always keep it 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.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

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 are a parent or caregiver, it’s important to ensure that children in this age group do not use this medication. Always consult with a healthcare professional if you have questions about appropriate treatments for younger children.

Geriatric Use

When considering this medication, it's important to note that it is not intended for use in children under 12 years of age. If you are an older adult or a caregiver, be aware that certain medications may affect you differently due to age-related changes in your body. Always consult with your healthcare provider about the appropriate dosage and any specific precautions you should take, especially if you have any health conditions or are taking other medications. Your safety and well-being are the top priority.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate it, as this can affect its performance.

When handling the product, always check that the safety seal under the child-resistant cap is intact. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

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. Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance.

FAQ

What does this drug do?

This drug temporarily relieves cough due to minor throat and bronchial irritation, which may occur with the common cold.

Who should not use this product?

This product is not intended for use in children under 12 years of age.

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

Adults and children 12 years and over should take 2 tablets every 6 to 8 hours as needed, without exceeding 8 tablets in a 24-hour period.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

Can I use this drug if I am pregnant or breastfeeding?

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

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

What should I do in case of overdose?

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

What should I ask my doctor before using this drug?

Ask a doctor before use if you have a cough accompanied by excessive phlegm or a persistent cough due to smoking, asthma, or emphysema.

What should I do if I am taking a monoamine oxidase inhibitor (MAOI)?

Do not use this drug if you are currently taking a prescription MAOI or for 2 weeks after stopping the MAOI.

How should I store this medication?

Store at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

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

Packaging configurations for Bupropidex.
Details

Drug Information (PDF)

This file contains official product information for Bupropidex, 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 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 the common cold.

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product should be used strictly according to the provided directions or as directed by a healthcare professional.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 to 8 hours, as needed. It is important not to exceed a total of 8 tablets within a 24-hour period.

This product is not intended for use in children under 12 years of age. Therefore, administration in this population is contraindicated.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 they are uncertain whether their prescription medication contains an MAOI.

Prior to use, patients should be instructed to seek medical advice if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, particularly in cases related to smoking, asthma, or emphysema.

Patients must be advised to discontinue use and consult a healthcare provider if a cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

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 kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this medication. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs used for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of two weeks following the discontinuation of an MAOI.

Before using this medication, patients should consult a healthcare professional if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, such as that which may occur with smoking, asthma, or emphysema.

Patients are advised to discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires further evaluation.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Additionally, this medication should be kept out of reach of children. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Bupropidex.
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 data for children in this age group, and therefore, it is contraindicated for use in this population.

Geriatric Use

Elderly patients may require careful consideration when using this adult product, which is not intended for use in children under 12 years of age. While specific dosage adjustments for geriatric patients are not provided, healthcare providers should exercise caution and closely monitor this population for any adverse effects or changes in efficacy. It is essential to evaluate the overall health status and comorbidities of elderly patients, as these factors may influence the safety and effectiveness of the treatment. Regular assessment and appropriate dose modifications may be necessary to ensure optimal therapeutic outcomes in this demographic.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care, symptomatic treatment, and specific antidotes if applicable. Healthcare providers should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of safeguarding the medication to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes a child-resistant cap with a safety seal. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product.

Additionally, the product features a tamper-evident design; therefore, it should not be used if the safety seal under the child-resistant cap is broken or missing. Proper handling and storage are crucial to ensure the product's efficacy and safety.

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. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should 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 experience.

Drug Information (PDF)

This file contains official product information for Bupropidex, 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 Bupropidex, 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

Last AI update:

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.