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Dextromethorphan hydrobromide/Guaifenesin

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Active ingredients
  • Guaifenesin 300 mg/5 mL
  • Dextromethorphan Hydrobromide 20 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
May 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 300 mg/5 mL
  • Dextromethorphan Hydrobromide 20 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Syrup
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 2021
Label revision date
May 15, 2025
Manufacturer
OPMX LLC
Registration number
M012
NDC roots
69729-020, 69729-040, 69729-062
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

PENTREX ADULT is a medication designed to provide temporary relief from cough caused by minor irritation in the throat and bronchial tubes, which can happen during a cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to drain your bronchial tubes.

If you're experiencing a cough due to these minor irritations, PENTREX ADULT may help alleviate your symptoms and make breathing more comfortable. Always consult with a healthcare professional for personalized advice and recommendations.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially during a cold, this medication can provide temporary relief. It works by soothing your throat and reducing the urge to cough, making it easier for you to feel comfortable.

Additionally, this medication helps to loosen phlegm (a thick mucus) and thin out bronchial secretions. This action can assist in clearing your bronchial tubes, making it easier to breathe and reducing congestion.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully. For adults and children aged 12 years and older, you should take 5 milliliters (mL) every 4 hours as needed. However, make sure not to exceed 6 doses within a 24-hour period. To ensure accurate dosing, always use the dosing cup that comes with the product.

Please note that this medication is not suitable for children under 12 years of age, so do not use it for younger children. By adhering to these guidelines, you can safely manage your symptoms while minimizing the risk of side effects.

What to Avoid

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

It's important to follow these guidelines to prevent potential serious interactions and ensure your safety. Always prioritize your health by seeking professional advice when in doubt.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not take it if you are currently using a prescription 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're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, 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, chronic bronchitis, or emphysema. You should stop using the medication and seek medical advice if your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious health issue.

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, you should 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.

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

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about 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

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 them. 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, chronic bronchitis, or emphysema.

Additionally, if your cough lasts more than 7 days, returns, or is accompanied by symptoms like 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 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 is safe and effective, especially if you have any concerns about your kidney health.

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 need to conduct liver function tests (which check how well your liver is working) and adjust your treatment plan accordingly. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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 guidance.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.

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 not to refrigerate the product, as this can affect its effectiveness. Additionally, keep the original carton, as it contains important information and labeling that you may need to refer to later.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with adults and children aged 12 years and older advised to take 5 mL every 4 hours. If you are under 12 years old, do not use this medication.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Always keep it out of reach of children, and in the event of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is PENTREX ADULT used for?

PENTREX ADULT is indicated for temporary relief of cough due to minor throat and bronchial irritation, which may occur with a cold.

How does PENTREX ADULT work?

It temporarily relieves cough and helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

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

The recommended dosage is 5 mL every 4 hours, with a maximum of 6 doses in any 24-hour period.

Can children under 12 use PENTREX ADULT?

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

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

Do not use PENTREX ADULT if you are currently taking an MAOI or have stopped taking one within the last 2 weeks. Consult a doctor or pharmacist if unsure.

When should I stop using PENTREX ADULT and consult a doctor?

Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

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

If you are pregnant or breastfeeding, ask a health professional before using PENTREX ADULT.

How should I store PENTREX ADULT?

Store PENTREX ADULT at 20°-25°C (68°-77°F) and do not refrigerate. Retain the carton for future reference.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Dextromethorphan Hydrobromide and Guaifenesin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PENTREX ADULT is a pharmaceutical formulation of Pentrexcilina, presented in a 4 fluid ounce (fl oz) container. The product is designed for use in adult populations and is labeled with the revision date of November 2024. The formulation is produced by AKRON and is available in both English and Spanish.

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. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying cause of cough or respiratory conditions.

Dosage and Administration

Adults and children 12 years and over are advised to take 5 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing should be measured exclusively with the dosing cup provided to ensure accuracy.

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 prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen.

Patients should discontinue use and seek medical advice if their 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.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to 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 with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients should be aware of the following warnings and recommendations regarding 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 two weeks after discontinuing an MAOI. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional before use.

Before using this product, patients should seek medical advice if they have a cough that is associated with excessive phlegm (mucus) or if they experience a cough that is chronic, such as those related to smoking, asthma, chronic bronchitis, or emphysema.

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

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, certain psychiatric conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Dextromethorphan Hydrobromide and Guaifenesin.
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 require special consideration when using this product, as it is not intended for use in children 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 productive with excessive phlegm (mucus). Additionally, those with a chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before initiating treatment.

Healthcare providers should instruct elderly patients to discontinue use and consult a physician if the cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation. Careful monitoring and appropriate dose modifications may be necessary to ensure the safety and efficacy of treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, consultation with a poison control center may provide valuable guidance in the management of potential overdosage cases.

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 text.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

Providers should also emphasize the necessity of keeping the medication out of reach of children. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and preventing adverse outcomes.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled room temperature of 20° to 25°C (68° to 77°F). Refrigeration is not recommended, as it may compromise the integrity of the product.

Healthcare professionals are advised to retain the carton for future reference to ensure access to the full labeling information. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 5 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, 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.

Drug Information (PDF)

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