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Guaifenesin 400mg Caplets

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Active ingredient
Guaifenesin 400 mg
Other brand names
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 2022
Label revision date
July 2, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 400 mg
Other brand names
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 2022
Label revision date
July 2, 2025
Manufacturer
Gendose Pharmaceuticals, LLC
Registration number
M012
NDC root
77333-360
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

Guaifenesin is a medication that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear your airways. By doing so, it helps make coughs more productive, allowing you to rid your bronchial passageway of bothersome mucus. This can be particularly helpful when you're dealing with respiratory conditions that cause 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.

Additionally, it makes your coughs more productive, meaning that when you do cough, it can help you expel mucus more effectively. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 caplet every 4 hours as needed while your symptoms continue. Make sure to swallow the caplet with a full glass of water to help it work effectively.

However, if you have a child under 12 years of age, it’s important not to use this medication for them. Always follow these guidelines to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important to be aware of certain side effects and warnings. You should consult your doctor if you have a persistent cough, especially if it’s related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus. It's crucial not to exceed the recommended dosage or use the product for more than 7 days.

If your cough lasts longer than 7 days, comes back, or is accompanied by symptoms like fever, rash, or a persistent headache, you should stop using the product and seek medical advice, as these could indicate a more serious condition. Additionally, if you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Warnings and Precautions

Before using this product, 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 (a condition affecting the lungs). You should also check with your doctor if your cough comes with excessive mucus. While using this product, make sure not to exceed the recommended dosage and avoid using it for more than 7 days.

If your cough lasts longer than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these symptoms could indicate a more serious condition. If you are pregnant or breastfeeding, please consult a healthcare professional before use. In case of an overdose, seek emergency medical help or contact a poison control center immediately at 1-800-222-1222.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone else may have taken too much of the medication, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Always keep medications out of reach and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this medication. They can provide guidance on whether it is safe for you and your baby. Always prioritize your health and the health of your child by seeking professional 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 and any medications you may consider.

Pediatric Use

It’s important to know that this medication is not recommended for children under 12 years of age. If you have a child who is 12 years or older, they can take one caplet every four hours as needed, but make sure they drink a full glass of water with it while their symptoms last. Always follow the dosage instructions carefully to ensure their safety and well-being.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F), allowing for brief excursions between 15° and 30°C (59° and 86°F). It's important to keep the product in a dry place and avoid exposing it to heat, as this can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication orally, with adults and children aged 12 and older advised to take 1 caplet every 4 hours as needed while symptoms persist. It's important to drink a full glass of water with each dose to help with absorption. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

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 12 years and older?

Adults and children 12 years of age and older should take 1 caplet every 4 hours with a full glass of water while symptoms persist.

Is Guaifenesin safe to use during pregnancy or breastfeeding?

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

Are there any contraindications for using Guaifenesin?

No contraindications are listed for Guaifenesin.

What should I do if my cough lasts more than 7 days?

You should stop using Guaifenesin and ask a doctor if your cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Can children under 12 years of age use Guaifenesin?

No, Guaifenesin should not be used by children under 12 years of age.

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 instructions for Guaifenesin?

Store Guaifenesin at 25°C (77°F) with excursions between 15° - 30°C (59° - 86°F) and keep it in a dry place away from heat.

Packaging Info

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

Packaging configurations for Guaifenesin 400mg Caplets.
Details

Drug Information (PDF)

This file contains official product information for Guaifenesin 400mg Caplets, 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 management of respiratory conditions characterized by excessive mucus production. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageway. Additionally, this medication aids in making coughs more productive, thereby improving respiratory function.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 caplet every 4 hours with a full glass of water, as needed, while symptoms persist.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Patients should consult a healthcare professional prior to using this product if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema, especially when mucus is present. Additionally, individuals experiencing a cough accompanied by excessive phlegm should seek medical advice before use.

When utilizing this product, it is imperative to adhere strictly to the recommended dosage and not to exceed it. The product should not be used for a duration exceeding 7 days.

Should the cough persist for more than 7 days, recur, or be accompanied by symptoms such as fever, rash, or a persistent headache, it is crucial to discontinue use and consult a healthcare professional. These symptoms may indicate a serious underlying condition that requires medical evaluation.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional before using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact a poison control center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, and it is important to seek medical advice under certain circumstances. Patients are advised to consult a healthcare professional before using this product if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema, particularly if accompanied by excessive phlegm.

While using this product, it is crucial not to exceed the recommended dosage and to limit use to no more than 7 days. Patients should discontinue use and consult a doctor if their cough lasts 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, pregnant or breastfeeding patients should seek guidance from a healthcare professional prior to use to ensure safety for both themselves and their child.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Guaifenesin 400mg Caplets.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 caplet every 4 hours, taken with a full glass of water, as needed while symptoms persist.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 before using this medication. The potential risks and benefits must be carefully considered in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare providers should evaluate the necessity of treatment against any potential risks to the mother and child.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual 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 management in the event of an overdose.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: nausea, vomiting, and gastrointestinal discomfort. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a poison control center at 1-800-222-1222. This information is vital for ensuring patient safety and should be clearly communicated during consultations.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to keep the product in a dry place, avoiding exposure to heat to maintain its efficacy and safety. Proper storage conditions are critical to ensure the product remains within the specified temperature range and is protected from environmental factors that could compromise its quality.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one caplet every four hours, taken with a full glass of water, as long as symptoms persist.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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