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Maximum Strength Mucus Relief

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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 2025
Label revision date
August 13, 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 2025
Label revision date
August 13, 2025
Manufacturer
SAM'S WEST INC
Registration number
ANDA217780
NDC root
68196-033
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 doing so, it can help make your coughs more productive, allowing you to breathe more comfortably. If you're dealing with congestion or a cough, this drug may provide relief by supporting your body's natural ability to expel mucus from the bronchial passageways.

Uses

If you're dealing with a cough that produces mucus, this medication can help. It works by loosening phlegm (a type of mucus) and thinning out bronchial secretions. This makes it easier for your body to clear out the mucus from your airways, leading to more productive coughs. By clearing the bronchial passageways, you can breathe more easily and feel more comfortable.

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 medication 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 specific guidelines when considering this medication. You should not use it for children under 12 years of age, as it may not be safe for them.

Currently, there are no specified contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). 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, comes back, or is accompanied by fever, rash, or a persistent headache, it’s important to stop using the medication and consult your doctor. These symptoms could indicate a more serious health issue that requires attention. Always prioritize your health and seek professional advice if you notice any concerning changes.

Warnings and Precautions

You should not use this medication if you are under 12 years old. Before using it, consult your doctor if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough is producing a lot of mucus.

If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop taking the medication and contact your doctor, as these may indicate a more serious condition. In the event of an overdose, seek emergency medical help immediately or call the Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your safety is the top priority.

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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, always consult with a healthcare provider before starting a new medication. They can help determine the best approach based on individual health needs and any other medications being taken.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for ensuring safety and effectiveness. They can monitor for any potential side effects and make recommendations tailored to your specific situation.

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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always share your complete list of medications and any tests you may undergo to avoid any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity of the device.

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 of any components.

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 safe use. If you have any questions about your treatment or how to take this medication, be sure to consult your healthcare provider.

FAQ

What does this drug do?

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

How should I take this medication?

Take 1 extended-release tablet every 12 hours with a full glass of water. Do not crush, chew, or break the tablet.

Who should not use this drug?

Do not use this drug 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.

Can I take this medication if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

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

What are the storage conditions for this drug?

Store the medication at 20-25°C (68-77°F).

Packaging Info

Below are the non-prescription pack sizes of Maximum Strength Mucus Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Mucus Relief.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength Mucus Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the management of respiratory conditions characterized by excessive mucus production. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. By enhancing mucociliary clearance, this medication aims to make coughs more productive, thereby alleviating symptoms associated with respiratory congestion.

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.

This product can be administered without regard for the timing of meals, allowing for flexibility in dosing. 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.

Use of this product is not recommended for children under 12 years of age.

Contraindications

Use is contraindicated in children under 12 years of age due to safety concerns associated with this population. No other contraindications have been specified.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age.

Healthcare professionals should advise patients to consult a physician prior to use if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

Patients are instructed to discontinue use and contact their healthcare provider if the 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.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients should 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. These symptoms may indicate the presence of a serious underlying illness that requires medical evaluation.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Mucus Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Mucus Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use is contraindicated for children in this age group.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of data limits the ability to make informed decisions about dosing and monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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. Additionally, there are no detailed findings available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients 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 to inform patients that this medication is not recommended for use in children under 12 years of age.

Patients should be instructed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to using this 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

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 Maximum Strength Mucus Relief, 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 Maximum Strength Mucus Relief, 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.