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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 2021
Label revision date
December 22, 2025
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 2021
Label revision date
December 22, 2025
Manufacturer
GRANULES USA, INC.
Registration number
ANDA213420
NDC root
69848-017
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

This medication is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways. By aiding in the removal of bothersome mucus, it helps make your coughs more productive, allowing for better breathing and comfort.

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 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 your meal schedule.

For adults and children aged 12 years 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 you have children under 12 years old, this medication is not suitable for them, so please avoid using it for that age group.

What to Avoid

It's important to be cautious when using this medication. You should not take it if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that requires medical 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 consult a healthcare professional if you have any concerns.

Side Effects

You should be aware that this medication is not recommended for children under 12 years of age. If your cough 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 your doctor, as these could indicate a more serious condition.

Before using this medication, talk to your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus.

Warnings and Precautions

You should not use this medication if you are under 12 years old. If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this product.

If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop taking the medication and contact your doctor. These symptoms could indicate a more serious health issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to be safe and get help right away.

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 this medication for your child.

Geriatric Use

It's important to note that this medication is not suitable for children under 12 years of age. For adults and older teens (12 years and older), the recommended dosage is 1 or 2 tablets every 12 hours, but you should not take more than 4 tablets in a 24-hour period.

If you are an older adult or caring for one, be mindful of these guidelines to ensure safe use. Always consult with a healthcare provider if you have any questions or concerns about the medication, especially regarding its effects on your health or any existing conditions.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is especially true if your creatinine clearance (a measure of how well your kidneys are filtering waste) is less than 30 mL/min. Regular monitoring of your renal function tests is also essential to ensure your kidneys are handling the medication properly. Always discuss any concerns with your healthcare provider to ensure your treatment is safe and effective.

Hepatic Impairment

If you have liver problems, it's important to use this medication with caution. Depending on the severity of your liver condition, you may need to adjust your dosage, especially if you have moderate to severe hepatic impairment (a condition where the liver does not function properly).

Additionally, if you have pre-existing liver disease, your healthcare provider will likely monitor your liver function tests (tests that check how well your liver is working) periodically. In cases of significant liver dysfunction, a reduced dose may be considered to ensure your safety while using this medication. Always consult your healthcare provider for personalized advice and adjustments.

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 tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

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 20-25°C (68-77°F). This helps maintain its quality and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 and older being 1 or 2 tablets every 12 hours. However, do not exceed 4 tablets in a 24-hour period. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication.

Make sure to keep this medicine out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What does this drug do?

This drug helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and aiding in clearing bothersome mucus from the bronchial passageways.

How should I take this medication?

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. Do not crush, chew, or break the tablet.

Who should not use this drug?

Do not use this drug if you are under 12 years of age, or 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, you should ask a health professional before using this medication.

Are there any side effects?

No specific side effects are mentioned, but you should stop use and consult a doctor if your cough lasts more than 7 days or is accompanied by fever, rash, or persistent headache.

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.

How should I store this medication?

Store the medication between 20-25°C (68-77°F) and do not use it 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

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

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 patients with a cough that 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 medical evaluation.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not prescribed to this demographic to avoid potential adverse effects.

For individuals who are pregnant or breastfeeding, it is imperative to consult a healthcare professional prior to use. This precaution is essential to assess the potential risks and benefits associated with the medication during these sensitive periods.

Patients should be 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. These symptoms may indicate a more serious underlying condition that requires further evaluation and intervention.

No specific laboratory tests are recommended for monitoring the safe use of this medication. However, healthcare providers should remain vigilant for any signs of adverse reactions or complications in patients receiving treatment.

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.

In clinical practice, patients are advised to stop use and consult a healthcare professional 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.

Additionally, patients should 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. 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 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 younger than 12 years.

Geriatric Use

Elderly patients should be carefully monitored when considering the use of this medication, particularly those aged 65 and older. The recommended dosage for adults and children aged 12 years and over is 1 or 2 tablets every 12 hours, with a maximum limit of 4 tablets within a 24-hour period.

It is important to note that this medication is not indicated for use in children under 12 years of age. Given the potential for altered pharmacokinetics in geriatric patients, healthcare providers should exercise caution and consider individual patient factors when determining the appropriate dosage. Regular assessment of efficacy and safety is advised to mitigate any risks associated with treatment in this population.

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 breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the health and safety of both the patient 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 medication 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 dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients regularly. For individuals with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to mitigate the risk of adverse effects associated with decreased kidney function.

Hepatic Impairment

Use of the medication in patients with hepatic impairment requires caution. For patients with moderate to severe hepatic impairment, dosage adjustments may be necessary to ensure safety and efficacy. It is recommended that liver function tests be monitored periodically in patients with pre-existing liver disease to assess their liver function status. In cases of significant hepatic dysfunction, consideration should be given to reducing the dose to mitigate potential risks associated with impaired liver function.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important to inform patients that they should discontinue use and seek medical advice 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.

Providers should also recommend that patients consult a doctor 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 advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

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 20-25°C (68-77°F). Proper adherence to these storage guidelines is essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 1 or 2 tablets every 12 hours, not to exceed 4 tablets within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should 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, 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.