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Pharbinex

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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 2019
Label revision date
January 20, 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 2019
Label revision date
January 20, 2025
Manufacturer
Ulai Health LLC
Registration number
M012
NDC root
73057-379
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

PHARBEST is a medication that contains guaifenesin (an expectorant) in a 400 mg dosage. It is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By doing so, PHARBEST can help make your cough more productive, allowing you to expel bothersome mucus more effectively.

This medication is available in immediate-release tablet form and is manufactured in the USA, with each package containing 30 tablets. It works similarly to the active ingredient found in Mucinex® Tablets, providing relief when you're dealing with congestion and mucus buildup.

Uses

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

Additionally, it makes your cough more productive, which means that when you do cough, it helps you expel mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve congestion.

Dosage and Administration

When taking this medication, make sure to swallow it with a full glass of water. You can take it at any time, regardless of your meals. For adults and children aged 12 and older, the recommended dose is one tablet every four hours as needed, but remember not to exceed six doses in a 24-hour period unless your doctor advises otherwise.

If you're giving this medication to a child aged 6 to under 12 years, the dose is half a tablet every four hours as needed. For children under 6 years old, it's important to consult a doctor before administering the 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.

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 these instructions closely.

Side Effects

If you experience a cough that lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these could indicate a serious illness. Additionally, you should talk to your doctor before using this medication if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing excessive mucus (phlegm).

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus. These conditions may require special attention.

If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, stop using the medication and call your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these could indicate a more serious health issue.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, 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 have concerns about an overdose, 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 professional advice if you think you or someone else may have taken too much of a medication.

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 specific guidelines based on their age. For adults and children aged 12 and older, you can give 1 tablet every 4 hours as needed. If your child is between 6 and 12 years old, the recommended dose is ½ tablet every 4 hours as needed.

For children under 6 years of age, it's crucial to consult with a doctor before administering the medication. This ensures their safety and helps determine the best course of action for their specific needs. Always follow these age-specific recommendations to ensure your child's well-being.

Geriatric Use

While there is no specific information about the use of PHARBINEX (guaifenesin 400mg tablet) in older adults, it’s important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this medication. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment (kidney issues) can affect how your body processes certain drugs. To ensure your safety and the effectiveness of your treatment, your healthcare provider will monitor your kidney function regularly. This includes checking your creatinine clearance (a measure of how well your kidneys are filtering waste) and performing renal function tests.

For those with significant kidney issues, special monitoring is essential. This helps your doctor determine if any changes to your medication are necessary, ensuring that you receive the best care possible while managing your condition. Always communicate openly with your healthcare team about your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This is because your liver's ability to process the drug can be affected. Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests (which check how well your liver is working) to ensure your safety while taking this medication.

Caution is advised when using this drug if you have liver impairment, as it may change how your body metabolizes (processes) the medication. Always discuss your liver health with your doctor to ensure you receive the appropriate care and adjustments needed for your treatment.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F and 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help ensure your safety and the proper functioning of the device.

Additional Information

You should take this medication with a full glass of water, and it can be taken at any time, regardless of meals. For adults and children aged 12 and over, the recommended dose is 1 tablet every 4 hours as needed, but do not exceed 6 doses in a 24-hour period unless directed by a doctor. For children aged 6 to under 12 years, the dose is ½ tablet every 4 hours as needed. If your child is under 6 years old, consult a doctor for guidance.

FAQ

What is PHARBEST?

PHARBEST is an expectorant containing 400mg of guaifenesin, designed to help loosen phlegm and thin bronchial secretions.

How should I take PHARBEST?

You should take PHARBEST with a full glass of water. Adults and children 12 years and older can take 1 tablet every 4 hours as needed, while children aged 6 to under 12 should take ½ tablet every 4 hours.

Are there any age restrictions for using PHARBEST?

Children under 6 years of age should ask a doctor before using PHARBEST.

What should I do if my cough lasts more than 7 days?

You should stop using PHARBEST and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Can I take PHARBEST if I am pregnant or breastfeeding?

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

What are the storage conditions for PHARBEST?

Store PHARBEST at 20°C - 25°C (68°F - 77°F).

Is there a maximum dosage for PHARBEST?

Do not exceed 6 doses in 24 hours or use as directed by a doctor.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Pharbinex.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PHARBEST is an immediate-release expectorant containing 400 mg of guaifenesin, the active ingredient comparable to that found in Mucinex® Tablets. Each bottle contains 30 tablets. PHARBEST is manufactured in the USA and is designated under NDC 73057-379-04.

Uses and Indications

This drug is indicated for the management of conditions associated with excessive mucus production in the respiratory tract. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication enhances the productivity of cough, thereby improving respiratory function.

Dosage and Administration

Patients should take this product with a full glass of water. It can be administered without regard for the timing of meals.

For adults and children aged 12 years and over, the recommended dosage is 1 tablet every 4 hours as needed, with a maximum of 6 doses in a 24-hour period, unless otherwise directed by a physician.

For children aged 6 to under 12 years, the recommended dosage is ½ tablet every 4 hours as needed, also adhering to the maximum of 6 doses in 24 hours unless otherwise advised by a healthcare professional.

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

Contraindications

There are no specific 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 consult a physician prior to use in patients with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice before initiating treatment.

In the event of an overdose, immediate medical assistance is crucial. Healthcare providers should instruct patients to contact a Poison Control Center or seek emergency medical help without delay by calling 1-800-222-1222.

Patients should be advised to discontinue use and consult a healthcare professional if the 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 underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. In the event that a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, patients are advised to discontinue use and consult a healthcare professional, as these symptoms may indicate a serious underlying condition.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, particularly if it is related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if the cough is accompanied by excessive phlegm (mucus), it is recommended that patients consult a doctor prior to use.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Pharbinex.
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

There is no specific information regarding the use of PHARBINEX (guaifenesin 400mg tablet) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors, including comorbidities and concurrent medications. Monitoring for efficacy and potential adverse effects is recommended 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 health 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 may necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Regular renal function tests should be performed to assess the need for dosage modifications. Additionally, special monitoring is required for patients with significant kidney problems to ensure optimal therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is essential to exercise caution when administering the drug to this population. Special monitoring of liver function tests is recommended to ensure patient safety and to assess the need for any further dosage modifications. Regular evaluation of liver function will help in managing the treatment effectively in patients with compromised liver function.

Overdosage

In the absence of specific information regarding overdosage in the available sections of the drug insert, healthcare professionals are advised to exercise caution when administering the medication.

Should an overdosage occur, it is essential to monitor the patient closely for any potential adverse effects, even if they are not explicitly detailed in the drug insert. The management of overdosage should be guided by the clinical presentation of the patient, and supportive care should be provided as necessary.

Healthcare professionals are encouraged to report any suspected overdosage cases to the appropriate regulatory authorities to contribute to the ongoing assessment of the drug's safety profile. In the event of an overdosage, it is recommended to consult a poison control center or a medical toxicologist for further guidance on management strategies tailored to the specific circumstances of the case.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

It is important for patients to consult with their healthcare provider prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema.

Additionally, patients should be encouraged to seek medical advice before using the product if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Patients should take the product with a full glass of water and may administer it without regard to meal timing. The recommended dosage for adults and children aged 12 years and older is 1 tablet every 4 hours as needed, not to exceed 6 doses in a 24-hour period unless directed by a physician. 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, consultation with a doctor is advised.

Drug Information (PDF)

This file contains official product information for Pharbinex, 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, 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.