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Guaifenesin

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Active ingredient
Guaifenesin 600–1200 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 2021
Label revision date
October 16, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600–1200 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 2021
Label revision date
October 16, 2025
Manufacturer
Granules India Ltd
Registration number
ANDA213420
NDC roots
62207-569, 62207-570
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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-ER is a medication designed to help loosen phlegm (mucus) and thin bronchial secretions. By doing so, it aids in clearing the bronchial passageways of bothersome mucus, making coughs more productive. This can be particularly helpful when you're dealing with respiratory issues that involve congestion.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a thick 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 mucus buildup.

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 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, and you can take it at any time, regardless of your meals.

For adults and children aged 12 and older, if you are using the 600 mg tablets, 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 tablets, take 1 tablet every 12 hours, and do not take more than 2 tablets in a 24-hour period. Please remember, this medication is not recommended for children under 12 years of age.

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 like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

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 seek medical advice if you have any concerns.

Side Effects

If you are considering using this medication, it's important to be aware of some potential side effects and warnings. You should not use this medication if you are under 12 years of age. 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 consult your doctor, as these could indicate a more serious condition.

Before using this medication, talk to 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. Being informed about these factors can help ensure your safety while using the medication.

Warnings and Precautions

It’s important to know that this medication should not be used in children under 12 years of age. If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with a healthcare professional before using any medication. This ensures that you understand any potential effects on your milk production or your nursing infant. Always prioritize your health and your baby's well-being by seeking expert advice.

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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 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. Do not use it 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

For adults and children aged 12 and older, the recommended dosage for the 600 mg tablets is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. If you are using the 1200 mg tablets, take 1 tablet every 12 hours, and do not exceed 2 tablets in a 24-hour period. Always follow these guidelines to ensure safe and effective use of the medication.

FAQ

What is Guaifenesin-ER used for?

Guaifenesin-ER helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing bothersome mucus from the bronchial passageways.

How should I take Guaifenesin-ER?

You should take Guaifenesin-ER with a full glass of water and not crush, chew, or break the tablet. It can be taken without regard for meals.

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

For adults and children 12 years and older, take 1 or 2 tablets every 12 hours, not exceeding 4 tablets in 24 hours for the 600mg dosage, or 1 tablet every 12 hours, not exceeding 2 tablets in 24 hours for the 1200mg dosage.

Is Guaifenesin-ER safe for children?

No, Guaifenesin-ER should not be used for children under 12 years of age.

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

You should stop using Guaifenesin-ER and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, as these could indicate a serious illness.

Are there any warnings associated with Guaifenesin-ER?

Yes, do not use Guaifenesin-ER for children under 12 years of age, and consult a doctor before use if you have a persistent cough or cough with excessive phlegm.

What should I do in case of an overdose?

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

What storage conditions are recommended for Guaifenesin-ER?

Store Guaifenesin-ER 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.

Should I consult a doctor before using Guaifenesin-ER?

Yes, you should ask a health professional before use, especially if you are pregnant or breastfeeding.

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

No description information is available for the specified 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

Patients should take the tablets with a full glass of water and must not crush, chew, or break them. This medication can be administered without regard for the timing of meals.

For adults and children aged 12 years and over, the recommended dosage is as follows:

  • For the 600 mg formulation: 1 or 2 tablets may be taken every 12 hours, with a maximum of 4 tablets in a 24-hour period.

  • For the 1200 mg formulation: 1 tablet may be taken every 12 hours, with a maximum of 2 tablets in a 24-hour period.

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

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Patients should not use this medication in children under 12 years of age due to safety concerns.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 for guidance.

Patients are instructed to discontinue use and consult their healthcare provider 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 management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated in children under 12 years of age.

In clinical practice, patients are advised to stop using the medication and consult a healthcare professional if their cough persists for more than 7 days, returns after resolution, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients should seek medical advice prior to use if they have a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema. Coughs accompanied by excessive phlegm (mucus) also warrant consultation with a healthcare provider before initiating treatment.

Drug Interactions

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

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. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 12 years.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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 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 available information.

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. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any unusual physiological changes.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology expert is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 provided in the insert.

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, or is accompanied by fever, rash, or a persistent headache, as these symptoms 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 a tamper-evident package. It is essential to inspect the carton before 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

For adults and children aged 12 years and over, the recommended administration of the medication is as follows: for the 600 mg formulation, patients should take 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. For the 1200 mg formulation, the dosage is 1 tablet every 12 hours, not to exceed 2 tablets in 24 hours. 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, 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

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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.