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Guaifenesin Extended Release 600 mg

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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 2024
Label revision date
October 22, 2024
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 2024
Label revision date
October 22, 2024
Manufacturer
Wal-Mart Stores, Inc.
Registration number
ANDA209215
NDC root
79903-271
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 Extended-Release Tablets 600mg are a type of expectorant, which means they help your body clear mucus from the airways. These tablets work by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to cough up bothersome mucus and relieve chest congestion. Each tablet is designed to provide relief for up to 12 hours, helping you breathe more comfortably throughout the day.

If you're experiencing a cough due to mucus buildup, Guaifenesin can make your coughs more productive by clearing out the mucus from your bronchial passageways. This medication is similar to the active ingredient found in Mucinex® Extended Release 600mg Tablets, offering effective support for your respiratory health.

Uses

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

In addition to helping with mucus, this medication also provides relief from chest congestion, making it easier for you to breathe comfortably. If you're dealing with thick mucus or congestion, this treatment can be an effective option to consider.

Dosage and Administration

When taking this medication, it's important to swallow the tablet whole—do not crush, chew, or break it. Make sure to take it with a full glass of water, which helps the tablet dissolve properly. You can take this medication at any time, regardless of whether you've eaten.

For adults and children aged 12 and older, the recommended dose is 1 or 2 tablets every 12 hours. However, be careful not to exceed 4 tablets in a 24-hour period. If your child is under 12 years old, this medication is not suitable for them, so please avoid using it.

What to Avoid

It's important to be aware of specific guidelines when considering 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, risks of abuse or misuse, or concerns regarding dependence (which means relying on a substance to function normally). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

If you experience a cough that lasts more than 7 days, returns after improvement, or is accompanied by fever, rash, or a persistent headache, it could indicate a serious illness, and you should seek medical attention. Additionally, if you have a chronic cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus, it's important to discuss these symptoms with your healthcare provider.

Warnings and Precautions

If you experience a cough that lasts more than 7 days, returns, or occurs alongside a fever, rash, or persistent headache, it’s important to stop using the medication and contact your doctor. These symptoms could indicate a more serious health issue that needs attention.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so don’t hesitate to reach out for assistance if you find yourself in this situation.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, your safety is the top priority, so don’t hesitate to reach out for help.

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 about the appropriate use of medications 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 you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your kidneys remain healthy while taking this medication, regular tests to check your renal function are recommended. If you have severe kidney impairment, your healthcare provider will need to monitor you more closely to adjust your treatment as necessary.

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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 is a positive sign. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the carton is sealed and the blister pack's printed seal is intact before use. If either is broken or missing, do not use the product.

For proper storage, keep the product in a cool, dry place at a temperature between 20 to 25°C (68 to 77°F). This helps maintain its quality and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 and older, the recommended dosage is 1 or 2 tablets every 12 hours, but do not exceed 4 tablets in a 24-hour period. 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 medication. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Guaifenesin Extended-Release Tablets used for?

Guaifenesin Extended-Release Tablets help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

How should I take Guaifenesin Extended-Release Tablets?

You should take 1 or 2 tablets every 12 hours with a full glass of water, and do not exceed 4 tablets in 24 hours.

Who should not use Guaifenesin Extended-Release Tablets?

Do not use this medication for children under 12 years of age.

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

Stop use and consult a doctor if your cough lasts more than 7 days, returns, or occurs with fever, rash, or persistent headache, as these may indicate a serious illness.

Are there any teratogenic effects associated with Guaifenesin?

No teratogenic effects are mentioned for Guaifenesin Extended-Release Tablets.

What should I do in case of an overdose?

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

Can I take Guaifenesin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Guaifenesin Extended-Release Tablets.

What are the storage conditions for Guaifenesin Extended-Release Tablets?

Store the tablets between 20 to 25°C (68 to 77°F) and do not use if the carton is open or the seal on the blister is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin Extended Release 600 mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin Extended Release 600 mg.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin Extended Release 600 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Guaifenesin Extended-Release Tablets contain 600 mg of guaifenesin, an expectorant designed to relieve chest congestion by thinning and loosening mucus. Each tablet is formulated for extended release, providing therapeutic effects for up to 12 hours. The product is supplied in a package containing 40 extended-release tablets, each designed to deliver the active ingredient effectively over an extended period.

Uses and Indications

This drug is indicated for the relief of chest congestion and the facilitation of productive coughs by loosening phlegm (mucus) and thinning bronchial secretions. It aids in clearing the bronchial passageways of bothersome mucus, thereby enhancing respiratory function.

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

Dosage and Administration

Patients should take the tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to administration. This product can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours. The total daily dosage should not exceed 4 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age.

Warnings and Precautions

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 mitigate potential health risks associated with overdose.

Healthcare professionals should advise patients to discontinue use and consult a physician 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 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 medication. Serious adverse reactions may include a persistent or chronic cough, which can occur in individuals with underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema.

It is important for patients to monitor their symptoms closely. If a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, these may be indicative of a serious illness requiring medical attention.

Additionally, patients may experience a cough that is accompanied by excessive phlegm (mucus). This symptom should also be evaluated by a healthcare professional to determine the appropriate course of action.

Overall, while some adverse reactions may be common, the presence of serious symptoms warrants immediate consultation with a healthcare provider.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. 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 Extended Release 600 mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin Extended Release 600 mg.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient data to support its safety and efficacy in this age group. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children under 12.

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.

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 no specific data available 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 may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to mitigate potential risks associated with reduced kidney function.

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 available information.

Overdosage

In the absence of specific details regarding overdosage for this product (SPL code 34088-5), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise. Symptoms may vary based on the pharmacological profile of the substance involved.

Management Procedures Management of overdosage should be tailored to the individual patient and may include the following steps:

  • Conduct a thorough assessment of the patient's condition.

  • Initiate supportive care as required.

  • Consider the use of activated charcoal if the patient presents within a suitable timeframe and is not at risk of aspiration.

  • Consult a poison control center or toxicology expert for guidance on further management strategies.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and remain alert to the potential for adverse effects.

Nonclinical Toxicology

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

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated contact number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals should ensure that the carton is not used if it is open or if the printed seal on the blister is broken or missing.

For optimal storage conditions, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Proper handling and storage are essential 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 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. It is not recommended for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, patients are advised to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guaifenesin Extended Release 600 mg, 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 Extended Release 600 mg, 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.