Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Guaifenesin

Last content change checked dailysee data sync status

Active ingredient
Guaifenesin 600–1200 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 2023
Label revision date
October 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600–1200 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 2023
Label revision date
October 17, 2025
Manufacturer
MARKSANS PHARMA LIMITED
Registration number
ANDA217780
NDC roots
25000-041, 25000-042
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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 are a medication designed to help you manage coughs associated with colds or respiratory conditions. Available in two formulations—600 mg and 1200 mg—these tablets work by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear your bronchial passageways of bothersome mucus, making your coughs more productive and easing your breathing.

You can find Guaifenesin in various packaging options, including blister packs and bottles, making it convenient to choose the amount that suits your needs.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a type of mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When taking the extended-release tablet, it's important to swallow it whole—do not crush, chew, or break it. Make sure to take it with a full glass of water. You can take this medication at any time, regardless of meals.

For adults and children aged 12 and older, if you are using the 600 mg tablet, you can take 1 or 2 tablets every 12 hours, but be careful not to exceed 4 tablets in a 24-hour period. If you are using the 1200 mg tablet, take 1 tablet every 12 hours, and do not take more than 2 tablets in a day. Please remember that this medication is not suitable for children under 12 years of age.

What to Avoid

You should not use this medication for children under 12 years of age. It's important to follow this guideline to ensure safety and avoid potential health risks. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication.

Side Effects

If you experience a cough that lasts more than 7 days, returns, 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 more serious health issue.

Before using this medication, you should also speak with your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus. Your health and safety are the top priority, so don’t hesitate to seek medical advice if you have any concerns.

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 emergency 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

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or believe you have taken too much of the medication, seek immediate medical help. It’s always better to err on the side of caution when it comes to your health. Remember, if you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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. For those 12 and older, the dosage varies depending on the strength. If your child is 12 or older, they can take either 600 mg or 1200 mg of the medication. For the 600 mg version, they can take 1 or 2 extended-release tablets every 12 hours, but should not exceed 4 tablets in a 24-hour period. For the 1200 mg version, the recommended dose is 1 extended-release tablet every 12 hours, with a maximum of 2 tablets in 24 hours.

Always consult with a healthcare professional before giving any medication to your child, especially if they are under 12, to ensure their safety and well-being.

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 your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. Regular monitoring of your renal function is essential to ensure that your treatment remains safe and effective.

For those with severe renal impairment, special care and consideration are necessary. Always discuss your kidney health with your healthcare provider to ensure that your treatment plan is appropriate for your condition.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. This means that you may need to adjust your dosage to ensure safety and effectiveness. For those with severe liver impairment, a lower dose may be necessary, or you might need to consider different treatment options altogether.

Additionally, regular monitoring of your liver function tests (which check how well your liver is working) is recommended. This helps your healthcare provider keep track of your liver health and make any necessary changes to your treatment plan. Always discuss your specific situation with your doctor to ensure the best care for your liver condition.

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 of your product, store it at a temperature between 20-25°C (68-77°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. If you have any specific disposal instructions, follow them carefully to ensure safety and compliance.

Additional Information

When taking this medication, it's important to follow the correct dosage and administration guidelines. For the 600 mg extended-release tablet, you should take 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. For the 1200 mg extended-release tablet, the recommended dose is 1 tablet every 12 hours, not exceeding 2 tablets in a day. Always take the tablet with a full glass of water, and do not crush, chew, or break it. This medication can be taken with or without food. Please note that it is not recommended for children under 12 years of age.

FAQ

What is Guaifenesin Extended-Release Tablets used for?

Guaifenesin helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

What are the available dosages for Guaifenesin Extended-Release Tablets?

Guaifenesin is available in 600 mg and 1200 mg formulations, with various packaging options.

How should I take Guaifenesin Extended-Release Tablets?

Do not crush, chew, or break the tablets. Take them with a full glass of water, and you can take them without regard for meals.

What is the recommended dosage for adults and children over 12 for the 600 mg formulation?

You can take 1 or 2 extended-release tablets every 12 hours, but do not exceed 4 tablets in 24 hours.

What is the recommended dosage for adults and children over 12 for the 1200 mg formulation?

You should take 1 extended-release tablet every 12 hours, and do not exceed 2 tablets in 24 hours.

Are there any age restrictions for using Guaifenesin Extended-Release Tablets?

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

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

Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

What should I do if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

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

How should I store Guaifenesin Extended-Release Tablets?

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

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 1200 mg, Guaifenesin 600 mg (guaifenesin 600 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 1200 mg, Guaifenesin 600 mg.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 1200 mg, Guaifenesin 600 mg, 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 drug.

Uses and Indications

This drug is indicated for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

For the 600 mg extended-release tablet, it is imperative that the tablet is not crushed, chewed, or broken prior to administration. The tablet should be taken with a full glass of water and can be administered without regard to the timing of meals. The recommended dosage for adults and children aged 12 years and older is 1 or 2 extended-release tablets every 12 hours, with a maximum limit of 4 extended-release tablets within a 24-hour period. This medication is not indicated for use in children under 12 years of age.

For the 1200 mg extended-release tablet, similar precautions apply: the tablet must not be crushed, chewed, or broken. It should also be taken with a full glass of water and can be administered without regard to meal timing. The recommended dosage for adults and children aged 12 years and older is 1 extended-release tablet every 12 hours, with a maximum limit of 2 extended-release tablets in a 24-hour period. This formulation is not suitable for 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.

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.

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 product. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a doctor if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying illness.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals should consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus). These considerations are important to ensure the safe and effective use of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin 1200 mg, Guaifenesin 600 mg (guaifenesin 600 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 1200 mg, Guaifenesin 600 mg.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage for the 600 mg formulation is 1 or 2 extended-release tablets every 12 hours, with a maximum of 4 extended-release tablets in a 24-hour period. For the 1200 mg formulation, the recommended dosage is 1 extended-release tablet every 12 hours, not to exceed 2 extended-release tablets in 24 hours. Safety and efficacy have not been established in pediatric patients under 12 years of age.

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. 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 currently no available data on 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 necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels to account for the reduced kidney function. Special consideration is warranted for patients with severe renal impairment, as they may require more careful management to avoid potential adverse effects.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments. It is recommended that these patients undergo special monitoring of liver function tests to assess their hepatic status and ensure safe administration of the drug.

For patients with severe hepatic impairment, a reduced dose may be required, or alternative therapy should be considered to mitigate potential risks associated with compromised liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this 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 this 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

For the 600 mg extended-release tablet, patients should not crush, chew, or break the tablet and must take it with a full glass of water. This medication can be administered without regard to meal timing. Adults and children aged 12 years and older are advised to take 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. The use of this product is not recommended for children under 12 years of age.

For the 1200 mg extended-release tablet, the same administration guidelines apply: do not crush, chew, or break the tablet, and take it with a full glass of water, regardless of meal timing. Adults and children aged 12 years and older should take 1 tablet every 12 hours, not exceeding 2 tablets in a 24-hour period. This formulation is also not suitable for children under 12 years of age.

Drug Information (PDF)

This file contains official product information for Guaifenesin 1200 mg, Guaifenesin 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 1200 mg, Guaifenesin 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

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.