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Dextromethorphan hydrobromide/Guaifenesin

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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
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 2019
Label revision date
April 5, 2024
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
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 2019
Label revision date
April 5, 2024
Manufacturer
OPMX LLC
Registration number
M012
NDC root
69729-781
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

PENTREXCILINA is a medication designed to help loosen phlegm (mucus) in your airways. It works by thinning bronchial secretions, which can make your coughs more productive. This means that when you have a cough, PENTREXCILINA can assist in clearing mucus from your lungs, making it easier for you to breathe and feel more comfortable.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) in your airways. By doing so, it makes your coughs more productive, allowing you to clear out mucus more effectively. If you're dealing with respiratory issues, this can be a helpful option to consider for improving your comfort and breathing.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take one softgel every four hours as needed, but make sure to drink a full glass of water with it. You should not take more than six doses in a 24-hour period, and you should not use this medication for more than seven consecutive days.

If you are considering this medication for a child under 12 years of age, please do not use it, as it is not recommended for that age group. Always remember to adhere to the recommended dosage to avoid any risk of overdose.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Do not use it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, consult your doctor or pharmacist.

Before using this product, talk to your doctor if you have a cough with excessive mucus, or if your cough is chronic due to smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than seven days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could indicate a more serious issue. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep this medication out of reach of children, and in case of overdose, seek medical help immediately, even if no symptoms are present.

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, or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before using this product.

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, chronic bronchitis, or emphysema. If you are pregnant or breastfeeding, seek advice from a healthcare professional. Always keep this product out of reach of children.

You should stop using this product and contact your doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Remember, acting quickly can make a significant difference, so don’t hesitate to get help. Your safety and health are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It’s important to know that this medication is not recommended for children under 12 years of age. If you have a child in this age group, you should avoid using this medication and consult with your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's safety and well-being when considering any medication.

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 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 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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's crucial to be aware of potential interactions with other medications. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain 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 current prescription includes an MAOI, it's important to consult with your doctor or pharmacist before starting this medication. Discussing all your medications and any lab tests with your healthcare provider helps ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25°C (68-77ºF). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is PENTREXCILINA used for?

PENTREXCILINA helps loosen phlegm (mucus) and thins bronchial secretions to make coughs more productive.

How should I take PENTREXCILINA?

Adults and children 12 years and older should take 1 softgel every 4 hours with a full glass of water while symptoms persist. Do not take more than 6 doses in 24 hours and do not use for more than 7 days.

Are there any contraindications for PENTREXCILINA?

You should not use PENTREXCILINA if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

Stop using PENTREXCILINA and ask a doctor if your cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Is PENTREXCILINA safe to use during pregnancy or breastfeeding?

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

What should I do in case of an overdose?

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

Who should not use PENTREXCILINA?

Children under 12 years of age should not use PENTREXCILINA.

How should I store PENTREXCILINA?

Store PENTREXCILINA at room temperature between 20-25°C (68-77°F) and avoid excessive heat and humidity.

Packaging Info

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

Packaging configurations for Dextromethorphan Hbr, Guaifenesin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PENTREXCILINA is a pharmaceutical compound characterized by its specific chemical properties. The molecular weight of PENTREXCILINA is not provided in the extracted data. The chemical formula is also unspecified. The drug is formulated in a dosage form suitable for its intended therapeutic use. Further details regarding its appearance and inactive ingredients are not included in the provided information.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients with respiratory conditions. It helps to loosen phlegm and thins bronchial secretions, thereby enhancing the productivity of coughs.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the recommended dosage is one softgel taken every four hours as needed, accompanied by a full glass of water, while symptoms persist. It is imperative that patients do not exceed six doses within a 24-hour period.

The use of this medication should not extend beyond a duration of seven days. For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should counsel patients on the importance of not exceeding the directed dosage and to be aware of the overdose warning associated with this medication.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

General precautions should be observed. Patients are advised to consult a healthcare provider before use if they are experiencing a cough that is productive with excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Pregnant or breastfeeding individuals should also seek guidance from a health professional before using this product. Furthermore, it is essential to keep this product out of reach of children to prevent accidental ingestion.

Patients should discontinue use and contact 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 requiring medical attention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious warnings include the contraindication of use in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients must refrain from using this product while taking an MAOI and for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription drug, patients are advised to consult a healthcare professional.

Before using this product, patients should seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with conditions such as 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.

Additional considerations include the recommendation for pregnant or breastfeeding individuals to consult a healthcare professional prior to use. It is also crucial to keep this product out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

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 verify whether their prescription medications contain an MAOI. If there is any uncertainty regarding the presence of an MAOI in their current medication regimen, patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Dextromethorphan Hbr, Guaifenesin.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. 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 considered, 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 the safety of both the mother and the developing fetus.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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. 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. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals are advised to monitor the patient closely and provide supportive care as necessary. The management of overdose may include symptomatic treatment and monitoring of vital signs. It is essential to assess the patient's condition thoroughly to determine the appropriate course of action.

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, and vomiting. Additionally, allergic reactions have been noted, which encompass rash, pruritus, and urticaria.

Patient Counseling

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ideally between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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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.