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Pharbinex-Dm

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Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, 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 2018
Label revision date
December 24, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg
  • Dextromethorphan Hydrobromide 20 mg
Other brand names
Drug classes
Expectorant, 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 2018
Label revision date
December 24, 2025
Manufacturer
Pharbest Pharmaceuticals, Inc.
Registration number
M012
NDC root
16103-381
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

PHARBINEX-DM is a medication that combines two active ingredients: guaifenesin (an expectorant that helps loosen phlegm and thin bronchial secretions) and dextromethorphan HBr (a cough suppressant). This combination works to make your cough more productive by clearing mucus from your airways and temporarily relieving cough caused by minor throat and bronchial irritation, which can occur with common colds.

Manufactured in the USA, PHARBINEX-DM is available in immediate-release tablets, making it easy to take when you need relief from coughing and congestion. If you're dealing with a cough and want to help clear your airways, this medication may be a suitable option for you.

Uses

If you're dealing with a cough or congestion, this medication can be quite helpful. It works by loosening phlegm (mucus) and thinning out bronchial secretions, which makes it easier for your body to clear out bothersome mucus from your airways.

Additionally, it can make your cough more productive, meaning you'll be able to cough up mucus more effectively. This medication also provides temporary relief from coughing caused by minor irritation in your throat and bronchial tubes, which often happens with a common cold.

Dosage and Administration

When taking this medication, make sure to swallow each tablet with a full glass of water. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 hours as needed, but remember not to exceed 6 doses in a 24-hour period.

If you are giving this medication to a child between the ages of 6 and 12, the dose is ½ tablet every 4 hours as needed, also not exceeding 6 doses in a day. For children under 6 years old, it’s important to consult a doctor before administering the medication to ensure safety and proper dosing.

What to Avoid

You can feel reassured that 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

It's important to be aware of certain warnings when using this medication. You should not take it if you are currently using a prescription Monoamine Oxidase Inhibitor (MAOI), which are medications often prescribed for depression, psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your prescription contains an MAOI, please consult your doctor or pharmacist.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance or contact 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, psychiatric conditions, or Parkinson's disease. Additionally, you must 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.

If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this product. In the event of an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious 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 giving this medication to children, it's important to follow the recommended dosages based on their age. For children aged 12 years and older, you can give them 1 tablet every 4 hours as needed. If your child is between 6 and 12 years old, the dosage is ½ tablet every 4 hours as needed.

For children under 6 years of age, it's crucial to consult a doctor before administering the medication. This ensures their safety and helps you get the best advice tailored to your child's needs. Always keep these guidelines in mind to help manage your child's health effectively.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (liver issues).

Before starting any new medication, including this one, it's essential to discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when taking certain medications. If you are currently using a prescription Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should not use this medication. Combining these can lead to serious interactions that may affect your health.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that you avoid potentially harmful interactions and keep your treatment safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 15° and 30°C (59° to 86°F). It's important to check the safety seal under the cap before use; do not use the product if the seal is broken or missing, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of the product. Always prioritize safety to ensure a positive experience.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is PHARBINEX-DM?

PHARBINEX-DM is a medication that contains Guaifenesin 400mg and Dextromethorphan HBr 20mg, functioning as an expectorant and cough suppressant.

How does PHARBINEX-DM work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough due to minor throat and bronchial irritation.

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

Adults and children 12 years and older should take 1 tablet every 4 hours as needed, not exceeding 6 doses in 24 hours.

What is the dosage for children aged 6 to under 12?

Children aged 6 to under 12 should take ½ tablet every 4 hours as needed.

What should I do if my child is under 6 years old?

Consult a doctor before giving PHARBINEX-DM to children under 6 years of age.

Are there any warnings associated with PHARBINEX-DM?

Do not use PHARBINEX-DM if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do in case of an overdose?

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

Can I use PHARBINEX-DM if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using PHARBINEX-DM.

How should I store PHARBINEX-DM?

Store PHARBINEX-DM at room temperature (15°-30°C) and do not use it if the safety seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Pharbinex-Dm (guaifenesin 400mg and dextromethorphan hbr 20mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pharbinex-Dm.
Details

Drug Information (PDF)

This file contains official product information for Pharbinex-Dm, 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 relief of cough associated with minor throat and bronchial irritation, which may occur due to common colds. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and making coughs more productive.

Limitations of Use: This medication is intended for temporary relief and should not be used as a long-term treatment for chronic cough or other serious respiratory conditions without consulting a healthcare professional.

Dosage and Administration

Patients should take the medication with a full glass of water. The maximum allowable dosage is 6 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed.

For children aged 6 to under 12 years, the dosage is ½ tablet every 4 hours as needed.

For children under 6 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription Monoamine Oxidase Inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a period of two weeks following the cessation of any MAOI treatment. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a prescribed medication.

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

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended without delay to address potential health risks effectively.

No specific laboratory tests are required for monitoring during the use of this product. However, healthcare providers should remain vigilant and provide appropriate guidance based on individual patient circumstances.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription Monoamine Oxidase Inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least two weeks after discontinuing an MAOI. Patients uncertain about whether their prescription medication contains an MAOI are advised to consult their doctor or pharmacist prior to using this product.

In the event of an overdose, it is critical to seek medical assistance immediately or contact a Poison Control Center. This product should be kept out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

The concomitant use of this medication with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy, as this may result in serious interactions.

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

Packaging & NDC

Below are the non-prescription pack sizes of Pharbinex-Dm (guaifenesin 400mg and dextromethorphan hbr 20mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pharbinex-Dm.
Details

Pediatric Use

Pediatric patients aged 12 years and older may take 1 tablet every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is ½ tablet every 4 hours as needed. It is advised that children under 6 years of age consult a doctor before use.

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 efficacy, 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 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

Patients with renal impairment have not been specifically addressed in the prescribing information 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly to ensure patient safety and optimal outcomes.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

Reports of adverse drug events have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events by contacting the dedicated call center at (866) 562-2756, available Monday through Friday from 8 AM to 4 PM.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, within the range of 15° to 30°C.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the safety seal under the cap is broken or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. 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 Pharbinex-Dm, 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 Pharbinex-Dm, 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.