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Guaifenesin

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Active ingredient
Guaifenesin 600 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Extended Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
April 29, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet, Extended Release
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 2022
Label revision date
April 29, 2022
Manufacturer
Kroger Company
Registration number
ANDA209254
NDC root
30142-961
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

Guaifenesin is an expectorant, which means it helps to loosen phlegm (mucus) and thin bronchial secretions. This action makes it easier for you to clear mucus from your airways, leading to more productive coughs and relief from chest congestion. Guaifenesin is commonly found in products like Mucinex® and is available in 600 mg extended-release tablets that work over a 12-hour period.

By thinning and loosening mucus, Guaifenesin can help you feel more comfortable when dealing with respiratory issues, allowing you to breathe easier and manage your symptoms more effectively.

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, making your coughs more productive.

In addition to easing your cough, this medication also provides relief from chest congestion, allowing you to feel more comfortable and breathe more freely. If you're dealing with thick mucus, this treatment can be particularly beneficial in thinning and loosening it, helping you to manage your symptoms effectively.

Dosage and Administration

When taking this medication, it's important to swallow the extended-release tablet whole. Do not crush, chew, or break it, as this can affect how the medication works. Make sure to take it with a full glass of water, and you can take it at any time, regardless of meals.

For adults and children aged 12 and older, the recommended dose is one or two extended-release tablets every 12 hours. However, you should not take more than four tablets in a 24-hour period. If you are caring for a child under 12 years old, please do not use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of specific guidelines when using this medication. You should not use it for children under 12 years of age, as it may not be safe for them.

Currently, there are no specified contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's advice and instructions to ensure safe use.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. Before using it, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces a lot of mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and seek medical advice, as these symptoms may indicate a more serious condition.

Warnings and Precautions

You should not use this medication if you are under 12 years old. Before using it, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing a lot of mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop taking the medication and contact your doctor, as these may be signs of a more serious condition. In case of an overdose, seek emergency medical help immediately or call the Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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 is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns regarding the use of this medication for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. 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 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 for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other treatments or tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests with them.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance.

When handling the product, be sure to check the packaging carefully. It is important not to use the product if the carton is open or if the printed seal on the blister pack is broken or missing, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with the recommended dosage for adults and children aged 12 and older being one or two extended-release tablets every 12 hours. It's important not to exceed a total of 4 extended-release tablets in a 24-hour period to ensure your safety and effectiveness of the treatment. If you have any questions about your medication or its use, be sure to consult your healthcare provider.

FAQ

What is Guaifenesin used for?

Guaifenesin is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

How should I take Guaifenesin?

You should take one or two extended-release tablets every 12 hours with a full glass of water, and do not exceed 4 tablets in 24 hours.

Who should not use Guaifenesin?

Guaifenesin should not be used by children under 12 years of age.

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

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, you should stop use and ask a doctor.

Are there any teratogenic effects associated with Guaifenesin?

No teratogenic effects are mentioned for Guaifenesin.

Can I take Guaifenesin if I am pregnant or breastfeeding?

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

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.

What are the storage conditions for Guaifenesin?

Store Guaifenesin between 20-25°C (68-77°F) and do not use if the carton is open or if the printed seal on the blister 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

Guaifenesin is an expectorant formulated as extended-release tablets, each containing 600 mg of the active ingredient. This medication is designed to relieve chest congestion by thinning and loosening mucus, facilitating easier expectoration. The extended-release formulation provides therapeutic effects over a 12-hour period. Each package contains 20 extended-release tablets.

Uses and Indications

This drug is indicated for the relief of chest congestion and to assist in the loosening of phlegm (mucus) and thinning of bronchial secretions. By facilitating the clearance of bothersome mucus, this medication enhances the productivity of coughs, thereby aiding in the management of respiratory conditions characterized by excessive mucus production.

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

Dosage and Administration

The extended-release tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended to administer the tablet with a full glass of water. This medication can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is one or two extended-release tablets every 12 hours. The total daily dosage should not exceed four extended-release tablets within a 24-hour period.

This medication is not indicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age due to safety concerns associated with this population. No other contraindications have been specified.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age.

Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

Patients are instructed to discontinue use and contact their healthcare provider 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.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated for children under 12 years of age. Prior to use, patients should consult a healthcare professional if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Patients are advised to discontinue use and seek medical attention 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.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been documented. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and use is contraindicated.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the 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 are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 at 1-800-222-1222.

It is important to inform patients that this medication is not recommended for use in children under 12 years of age. Patients should be counseled to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Additionally, healthcare providers should encourage patients to consult a doctor before using the medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to inspect the packaging prior to use; do not use if the carton is open or if the printed seal on the blister is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one or two extended-release tablets every 12 hours, with a maximum limit of four extended-release tablets within a 24-hour period.

No additional information is available regarding laboratory tests, abuse potential, 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.