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Guaifenesin

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
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 ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
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
16103-379
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 is a medication manufactured in the USA that contains 400 mg of guaifenesin, which is an expectorant. This means it helps loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, PHARBINEX can help make your cough more productive, allowing you to breathe more comfortably.

If you're familiar with MUCINEX® Tablets, PHARBINEX works in a similar way, providing relief from congestion and helping to alleviate symptoms associated with respiratory conditions.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways.

Additionally, it makes your cough more productive, meaning that it helps you cough up the mucus more effectively. This can be particularly helpful when you're dealing with respiratory issues that involve excess mucus.

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 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, they should take ½ tablet every 4 hours as needed, also not exceeding 6 doses in a day.

If your child is under 6 years old, it’s important to consult a doctor before administering this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache. These could be signs of a more serious condition that needs medical attention.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following the recommended instructions and seeking professional advice when necessary.

Side Effects

You should consult your doctor before using this medication if you have a persistent or chronic cough, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive phlegm (mucus).

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these symptoms may indicate a more serious condition. In the event of an overdose, it is crucial to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough is accompanied by excessive phlegm (mucus), you should also seek medical advice.

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns after improvement, or occurs with symptoms like fever, rash, or a persistent headache, as these may indicate a more serious condition.

In the event of an overdose, seek emergency 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 under 12 years old, the dosage is ½ tablet every 4 hours as needed.

For children under 6 years of age, you should consult a doctor before using this medication. This ensures that you get the best advice for your child's specific needs and safety. 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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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, you should 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 this 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?

PHARBINEX is an immediate-release expectorant that contains 400mg of Guaifenesin, manufactured in the USA, and comes in a package of 30 tablets.

How does PHARBINEX work?

PHARBINEX helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing the bronchial passageways.

What are the recommended dosages for PHARBINEX?

Adults and children 12 years and older should take 1 tablet every 4 hours as needed, while children aged 6 to under 12 should take ½ tablet every 4 hours. Consult a doctor for children under 6.

Are there any warnings for using PHARBINEX?

You should ask a doctor before use if you have a persistent cough, chronic cough, or a cough with excessive phlegm. Stop use and consult a doctor if your cough lasts more than 7 days or is accompanied by fever, rash, or persistent headache.

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 if I am pregnant or breastfeeding?

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

How should I store PHARBINEX?

Store PHARBINEX at room temperature between 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 Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin, 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 management of conditions associated with excessive mucus production in the respiratory tract. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication aids in making coughs more productive.

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

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed, with a maximum of 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the dosage is ½ tablet every 4 hours as needed, also not to exceed 6 doses in a 24-hour period.

For children under 6 years of age, it is advised to consult a healthcare professional before administration.

Contraindications

There are no contraindications listed for this product.

However, it is advised to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious condition that requires medical evaluation.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this medication. It is imperative to advise patients to consult their physician prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough that is accompanied by excessive phlegm (mucus) should also seek medical advice before initiating treatment.

Patients should be instructed to discontinue use and consult a healthcare provider if their 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 more serious underlying condition that requires further evaluation.

In the event of an overdose, it is crucial to seek emergency medical assistance immediately or contact a Poison Control Center. Prompt action is necessary to mitigate potential health risks associated with overdose.

Side Effects

Patients should be aware of several important warnings and adverse reactions associated with the use of this medication. Prior to use, it is advised that individuals consult a healthcare professional if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before proceeding with treatment.

Patients are instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center. This precaution is essential to ensure the safety and well-being of patients.

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 Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin.
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 therapeutic response, 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 mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may occur.

Management of an overdose should be guided by established protocols and may involve supportive care, symptomatic treatment, and specific interventions as deemed necessary by medical personnel. Continuous assessment and monitoring of the patient's condition are recommended to ensure appropriate management and to address any complications that may arise.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 keep the medication out of reach of children to prevent accidental ingestion.

In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance.

Patients should also be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, maintaining a range of 15° to 30°C to ensure its efficacy and safety.

Healthcare professionals should also be aware that the product must not be used if the safety seal under the cap is broken or missing, as this may indicate potential contamination or compromise of the product's integrity. Proper handling and adherence to these storage conditions are vital for maintaining the quality of the product.

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 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 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

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.