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Guaifenesin

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Active ingredient
Guaifenesin 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 2022
Label revision date
December 1, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 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 2022
Label revision date
December 1, 2023
Manufacturer
RITE AID CORPORATION
Registration number
ANDA210453
NDC root
11822-4260
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Guaifenesin Extended-Release is a maximum strength expectorant designed to provide effective mucus relief. Each tablet contains 1200 mg of guaifenesin, which helps to loosen phlegm (mucus) and thin bronchial secretions. This action aids in clearing the bronchial passageways of bothersome mucus, making coughs more productive and relieving chest congestion.

By thinning and loosening mucus, Guaifenesin Extended-Release can help you breathe easier and feel more comfortable when dealing with respiratory issues. It is similar to the active ingredient found in Maximum Strength Mucinex, and is formulated to provide relief over a 12-hour period.

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. If you're experiencing chest congestion, this medication can also provide relief by thinning and loosening mucus, allowing for easier breathing.

Overall, it works to improve your respiratory comfort by addressing mucus buildup and congestion.

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 one tablet every 12 hours. However, you should not take more than two tablets in a 24-hour period. If you have children under 12 years of age, this medication is not suitable for them, so please avoid using it for that age group.

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 concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any questions or 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, 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 or chronic 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 be aware of some key warnings and precautions when using this medication. First, do not use it for 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 the medication and call your doctor if your cough lasts more than 7 days, returns, or occurs alongside symptoms like fever, rash, or a persistent headache. These 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, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. 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 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 is at least 12 years old 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

As you age, your body may respond differently to medications, which means you might experience side effects more intensely than younger adults. This increased sensitivity is important to keep in mind when discussing treatment options with your healthcare provider.

Additionally, if you or a loved one has reduced kidney function, which is common in older adults, your doctor may need to adjust the dosage of certain medications to ensure safety and effectiveness. While the medication insert does not specify particular dosage recommendations for older adults, it’s crucial to have open conversations with your healthcare team about any concerns or changes in health.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication as directed, with adults and children aged 12 and older typically taking 1 tablet every 12 hours. It's important not to exceed 2 tablets in a 24-hour period. If you are pregnant or breastfeeding, be sure to consult a healthcare professional before using this medication to ensure it is safe for you.

FAQ

What is Guaifenesin Extended-Release used for?

Guaifenesin Extended-Release is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

How should I take Guaifenesin Extended-Release?

You should take 1 tablet every 12 hours with a full glass of water. Do not exceed 2 tablets in 24 hours, and do not crush, chew, or break the tablet.

Who should not use Guaifenesin Extended-Release?

This product should not be used by 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, as these could be signs of a serious illness.

Is it safe to use Guaifenesin Extended-Release during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What are the storage conditions for Guaifenesin Extended-Release?

Store Guaifenesin Extended-Release between 20° to 25°C (68° to 77°F).

Are there any contraindications for Guaifenesin Extended-Release?

No specific contraindications are mentioned for Guaifenesin Extended-Release in the provided information.

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 relief of chest congestion and to assist in the loosening of phlegm (mucus) and thinning of bronchial secretions. By facilitating the clearance of bothersome mucus, this medication enhances the productivity of coughs, thereby aiding in the management of respiratory conditions characterized by excessive mucus production.

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

Dosage and Administration

Patients should take the tablet whole, without crushing, chewing, or breaking it. It is recommended to administer the tablet with a full glass of water. This medication can be taken without regard to the timing of meals.

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

This medication is not indicated 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 without delay.

Patients are instructed to discontinue use and consult a 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 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, returns, 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. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this medication. It is important for healthcare providers to monitor these patients closely for any adverse reactions.

Due to the potential for reduced kidney function in geriatric patients, dosage adjustments may be necessary to ensure safety and efficacy. However, the prescribing information does not provide specific dosage recommendations or age considerations for this population. Therefore, clinicians should exercise caution and consider individual patient factors when prescribing this medication to elderly patients.

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 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients 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 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 indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

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. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific 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

The available nonclinical study data does not indicate any teratogenic or non-teratogenic effects. Additionally, there is no information provided regarding animal pharmacology and toxicology. As such, no specific findings related to carcinogenesis, mutagenesis, or impairment of fertility are available.

Postmarketing Experience

No postmarketing experience details are provided in the drug 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. It is important for patients to stop using the medication and consult a healthcare provider if their cough persists for more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should also be encouraged to discuss their medical history with their healthcare provider before using this medication, particularly if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be advised to consult a healthcare provider if their cough is accompanied by excessive phlegm (mucus) to ensure appropriate management and care.

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° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper handling procedures should be followed to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. 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

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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.