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 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 2020
Label revision date
November 7, 2025
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 2020
Label revision date
November 7, 2025
Manufacturer
WALGREEN CO.
Registration number
ANDA210453
NDC root
0363-0033
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 an active ingredient found in Mucinex Maximum Strength, specifically formulated as a 12-hour extended-release tablet containing 1200 mg. This medication is designed to help relieve chest congestion by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to clear your airways and have more productive coughs.

Recommended by pharmacists, Guaifenesin is suitable for use both day and night, providing maximum strength relief when you need it most. Each package contains 14 tablets, ensuring you have enough supply to help manage your symptoms effectively.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes it easier for you to clear out bothersome mucus from your bronchial passageways, which can lead to more productive coughs.

In addition to helping with mucus, this medication also provides relief from chest congestion, making it a useful option when you're feeling blocked up or uncomfortable in your chest. Overall, it works to thin and loosen mucus, helping you feel more at ease.

Dosage and Administration

When taking this medication, it's important to swallow the extended-release tablet whole. Do not crush, chew, or break it, as this can affect how the medicine works. Make sure to take it with a full glass of water, and you can take it at any time, regardless of meals.

For adults and children aged 12 years and older, the recommended dose is one extended-release tablet every 12 hours. Be careful not to take more than two 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 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. Additionally, if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using it and consult a doctor, as these may 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 producing 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 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 stop taking this medication and call your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a 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, 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 that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to err on the side of caution and get help.

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

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, it’s important to consult with a healthcare provider before starting the medication. 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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should take this medication orally, with adults and children aged 12 and older typically using one extended-release tablet every 12 hours. It's important not to exceed two extended-release tablets in a 24-hour period to ensure safety and effectiveness. If you have any questions about your dosage or how to take the medication, be sure to consult your healthcare provider.

FAQ

What is Guaifenesin used for?

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

How should I take Guaifenesin?

You should take 1 extended-release tablet every 12 hours with a full glass of water. Do not exceed 2 tablets in 24 hours.

Can children use Guaifenesin?

No, Guaifenesin is not recommended 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 teratogenic effects associated with Guaifenesin?

No teratogenic effects are mentioned for Guaifenesin.

What should I do if I am pregnant or breastfeeding?

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

What are the storage conditions for Guaifenesin?

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

Is there any specific information regarding overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

The extended-release tablet should be taken with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken, as this may affect the release mechanism of the medication.

For adults and children aged 12 years and older, the recommended dosage is one extended-release tablet every 12 hours. The total daily dosage should not exceed two extended-release tablets within a 24-hour period. This medication can be administered without regard to the timing of meals.

Use of this product is not recommended for 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

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.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation and intervention. Regular monitoring of these symptoms is essential to ensure patient safety and appropriate management.

Side Effects

Patients should be aware that the use of this medication is not recommended for children under 12 years of age. In clinical practice, it is advised to discontinue use and consult a healthcare professional if a 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.

Before initiating treatment, patients should seek medical advice if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider prior to use.

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 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 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 indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

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 further guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution and be prepared to respond promptly to any suspected overdose situations.

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 available in the insert text.

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 after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these 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 medication 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° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one extended-release tablet every 12 hours for adults and children aged 12 years and older. Clinicians should advise patients not to exceed a total of two extended-release tablets within a 24-hour period. No further 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

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.