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Guaifenesin Extended Release 1200 mg, Guaifenesin Extended Release 600 mg

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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 2024
Label revision date
February 7, 2024
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 2024
Label revision date
February 7, 2024
Manufacturer
TIME CAP LABORATORIES, INC.
Registration number
ANDA217780
NDC roots
49483-723, 49483-724
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 a medication that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear your airways. By doing this, it aids in making coughs more productive, allowing you to expel bothersome mucus from your bronchial passageways. This can be particularly helpful when you're dealing with respiratory conditions that cause congestion.

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. This can be particularly helpful if you're dealing with a cough that feels unproductive or if you're experiencing congestion.

You can expect this medication to assist in clearing your airways, allowing for easier breathing and more effective coughing.

Dosage and Administration

When taking this medication, it's important to follow a few key guidelines to ensure it works effectively. If you're using the 600 mg extended-release tablet, remember not to crush, chew, or break it. Instead, take the tablet with a full glass of water. You can take it at any time, regardless of meals. For adults and children aged 12 and older, the recommended dose is 1 or 2 tablets every 12 hours, but make sure not to exceed 4 tablets in a 24-hour period. If the patient is under 12 years old, this medication should not be used.

For the 1200 mg extended-release tablet, the same rules apply: do not crush, chew, or break the tablet, and take it with a full glass of water. You can also take this medication without worrying about meal times. Adults and children aged 12 and older should take 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. Again, this medication is not suitable for children under 12 years of age. Always follow these instructions carefully 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. There are no additional contraindications or concerns regarding controlled substance classification, abuse, misuse, or dependence mentioned in the provided information. 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, 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, if you have a chronic cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing excessive mucus, you should also speak with a healthcare professional before using this medication.

Warnings and Precautions

If you experience an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this medication and call your doctor if your cough lasts more than 7 days, returns after improvement, or occurs alongside symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, 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 if you believe you have taken too much of the medication, 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 checked out if you have concerns about an overdose.

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

This medication is not recommended for children under 12 years of age. If your child is 12 or older, the dosage differs based on the strength of the medication. For the 600 mg version, both adults and children aged 12 and up can take 1 or 2 extended-release tablets every 12 hours, but they 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

While there are no specific guidelines or recommendations for older adults regarding this medication, it's always important to approach any new treatment with caution. Since the insert does not mention any dosage adjustments or safety concerns for elderly patients, you should still consult with your healthcare provider to ensure that this medication is appropriate for your individual health needs.

If you or a loved one is an older adult, discussing any potential risks or benefits with a doctor can help ensure safe and effective use of the medication. Always prioritize open communication with your healthcare team to address any questions or concerns you may have.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Before starting treatment, your healthcare provider will assess your creatinine clearance (a measure of how well your kidneys are filtering waste) to ensure it's safe for you.

During your treatment, regular tests to monitor your kidney function are recommended. If you have significant renal impairment, a lower dose of the medication may be necessary to avoid potential complications. Always stay in close contact with your healthcare team to ensure your treatment is safe and effective.

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 the best treatment plan for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always inform your doctor about all the medications, supplements, and over-the-counter products you use. This helps them monitor your health effectively and make informed decisions about your treatment plan. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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

For the 600 mg dosage, adults and children aged 12 and older can take 1 or 2 extended-release tablets every 12 hours, but you should not exceed 4 tablets in a 24-hour period. For the 1200 mg dosage, adults and children 12 years and older should take 1 extended-release tablet every 12 hours, with a maximum of 2 tablets in 24 hours. It's important to note that this medication is not recommended for children under 12 years of age.

FAQ

What is Guaifenesin used for?

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

How should I take Guaifenesin?

Take Guaifenesin with a full glass of water. Do not crush, chew, or break the extended-release tablet.

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

For 600 mg, take 1 or 2 extended-release tablets every 12 hours, not exceeding 4 tablets in 24 hours. For 1200 mg, take 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours.

Can children use Guaifenesin?

No, Guaifenesin should not be used 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.

Are there any precautions for pregnant or breastfeeding women?

If you are pregnant or breastfeeding, 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.

Are there any contraindications for using Guaifenesin?

No specific contraindications are mentioned, but consult a doctor if you have a persistent or chronic cough.

Packaging Info

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

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

Drug Information (PDF)

This file contains official product information for Guaifenesin Extended Release 1200 mg, 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 is a medication with a chemical name of Guaifenesin, formulated to provide a strength of 1200 mg per dosage unit. It is available in packaging options of 70 count and 600 mg in 500 count.

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.

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 advised to stop use and consult a doctor if a cough lasts more than 7 days, returns, or occurs alongside fever, rash, or persistent headache, as these symptoms may indicate a serious illness.

Additionally, it is recommended that patients seek medical advice prior to use if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus).

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 1200 mg, Guaifenesin Extended Release 600 mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin Extended Release 1200 mg, Guaifenesin Extended Release 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 geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned in the text. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and overall health status.

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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 to assess creatinine clearance prior to initiating therapy in this population. Close monitoring of patients with reduced renal function is recommended throughout the treatment course. Regular renal function tests should be conducted to evaluate any changes. For patients with significant renal impairment, a reduced dose may be required to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to ensure safety and efficacy. Caution should be exercised when administering the drug to patients with compromised liver function, as their response to treatment may differ from that of patients with normal liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is vital for ongoing management and potential reporting requirements.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nausea, vomiting, dizziness, and headache. These events have been documented in the context of routine pharmacovigilance activities.

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 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 administration of the medication, adults and children aged 12 years and older may take 1 or 2 extended-release tablets of 600 mg every 12 hours, with a maximum of 4 tablets in a 24-hour period. For the 1200 mg dosage, the recommended regimen is 1 extended-release tablet every 12 hours, not to exceed 2 tablets in 24 hours. The medication is not recommended for use in children under 12 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Guaifenesin Extended Release 1200 mg, 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 1200 mg, 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.

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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.