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Guaifenesin 400mg

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Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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 2024
Label revision date
November 13, 2025
Manufacturer
Marlex Pharmaceuticals Inc
Registration number
M012
NDC root
10135-790
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Guaifenesin is a medication that helps 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 (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 using this medication, it's important to follow the recommended dosage to ensure your safety and effectiveness. For adults and children aged 12 years and older, you can take 1 to 2 tablets every 4 hours as needed. However, make sure not to exceed 6 doses within a 24-hour period.

If you have children under 12 years of age, please do not use this product for them, as it is not intended for that age group. Always remember to read the instructions carefully and consult with a healthcare professional if you have any questions or concerns about using this medication.

What to Avoid

It's important to be aware of certain precautions when using this product. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should take care to ensure the product is safe to use.

Do not use this product if the safety seal under the cap is broken or missing, as this indicates that the product may have been tampered with. Always check the seal before use to ensure your safety.

Side Effects

If you are considering using this medication, it's important to be aware of some potential side effects and warnings. You should consult a doctor before use if you have a persistent cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema, or if your cough is accompanied by excessive mucus.

You should stop using the medication and seek medical advice if your cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious condition. In the event of an overdose, it is crucial to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent or chronic cough, especially if it's related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, if your cough is accompanied by excessive phlegm (mucus), you should also seek medical advice.

You should stop using the medication and contact your doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache, as these may indicate a more serious condition. Always check that the safety seal under the cap is intact before use; do not use the product if it is broken or missing. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious when it comes to your health.

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

This product is not suitable for children under 12 years of age. If you have a child who is 12 years or older, you can give them 1 to 2 tablets every 4 hours as needed. However, it’s important to avoid using this medication for children younger than 12, as it is not intended for their use. Always consult with a healthcare professional if you have any questions or concerns about 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, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always ensure that your doctor is aware of all medications being taken, as older adults may be more sensitive to certain drugs. Regular check-ins with your healthcare team can help monitor for any side effects or changes in health.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall 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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 best performance and safety of your product, store it in a cool, dry place at a temperature between 15°C and 30°C (59°F and 86°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Guaifenesin used for?

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

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

Adults and children 12 years and over should take 1 to 2 tablets every 4 hours, not exceeding 6 doses in any 24-hour period.

Is Guaifenesin safe for children?

This product is not intended for use in children under 12 years of age.

What should I do if I experience an overdose?

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

Are there any warnings before using Guaifenesin?

Ask a doctor before use if you have a persistent cough, chronic cough, or cough with too much phlegm (mucus).

When should I stop using Guaifenesin?

Stop use and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

What should I do if the safety seal is broken or missing?

Do not use the product if the imprinted safety seal under the cap is broken or missing.

Is Guaifenesin safe to use during pregnancy or breastfeeding?

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

What is the storage requirement for Guaifenesin?

Store Guaifenesin at 15°C-30°C (59°F-86°F).

Packaging Info

Below are the non-prescription pack sizes of Guaifenesin 400mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 400mg.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 400mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No Description information provided.

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 passageway.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 to 2 tablets every 4 hours as needed. It is important not to exceed 6 doses within a 24-hour period. This product is contraindicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in patients if the tamper-evident safety seal under the cap is broken or missing. This precaution is essential to ensure the integrity and safety of the product.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when recommending this product. Prior to use, patients should be instructed to consult a physician if they have a persistent or chronic cough, particularly if it is 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 using this product.

Patients should be advised to discontinue use and consult a healthcare provider if their 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 more serious underlying condition that requires medical evaluation.

It is imperative to ensure the integrity of the product prior to use. The product should not be used if the tamper-evident safety seal under the cap is broken or missing, as this may compromise safety.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay to ensure appropriate management.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a healthcare professional prior to use if there is a history of persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before using this product.

Patients are instructed to discontinue use and consult a healthcare provider if the 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 medical evaluation.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. This precaution is essential to ensure patient safety and appropriate management of any adverse effects that may arise.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 400mg (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guaifenesin 400mg.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For adolescents aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. There are no established safety or efficacy data for children under 12 years, and therefore, use in this population is contraindicated.

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, given the lack of targeted data for 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 lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 medication in 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to be aware of the signs that warrant discontinuation of the medication; they should stop use and consult a doctor if their cough persists for more than 7 days, returns after resolution, 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 emphasize the importance of product integrity by instructing patients not to use the medication if the tamper-evident safety seal under the cap is broken or missing. This precaution helps ensure the safety and efficacy of the product.

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 temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Guaifenesin 400mg, 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 400mg, 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.