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Excaugh

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Active ingredient
Guaifenesin 100 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 2016
Label revision date
November 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 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 2016
Label revision date
November 13, 2025
Manufacturer
FORTUNE PHARMACAL COMPANY, LIMITED
Registration number
M012
NDC root
51467-009
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

EXCAUGH contains guaifenesin, which is an expectorant. 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 aiding in the removal of bothersome mucus, EXCAUGH can help make your coughs more productive, allowing for better breathing and comfort.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in clearing 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

If you are an adult or a child aged 12 years and older, you should take 2 to 4 tablets every 4 hours as needed. However, make sure not to exceed 24 tablets (which is 2,400 mg) in a 24-hour period. For children between the ages of 6 and under 12, the recommended dosage is 1 to 2 tablets every 4 hours, with a maximum of 12 tablets (1,200 mg) in a day.

If your child is under 6 years old, it’s important to consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

If you experience a cough that lasts more than a week, keeps coming back, or is accompanied by a 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 condition that requires medical attention. Always prioritize your health and seek guidance if you have any concerns.

Side Effects

If you experience a cough that lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, it's important to stop using the medication and consult your doctor. Additionally, if you have a chronic cough due to conditions like smoking, asthma, chronic bronchitis, or emphysema, or if your cough comes with excessive mucus or a high fever, you should also speak with your healthcare provider before using this medication.

Currently, there are no specific side effects or additional adverse reactions listed for this medication.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema. You should also seek advice if your cough produces a lot of mucus or if you have a high fever.

If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, stop taking the medication and call your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the 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, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember to use medications as directed by your healthcare provider to minimize the risk of any adverse effects.

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

When giving medication to children, it's important to follow specific guidelines. For children aged 6 to under 12 years, you can administer 1 to 2 tablets every 4 hours, but make sure not to exceed 12 tablets (which is 1,200 mg) in a 24-hour period.

If your child is under 6 years old, it's crucial to consult a doctor before giving any medication. This ensures their safety and helps you get the right advice tailored to their needs. Always prioritize your child's health by following these recommendations closely.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help determine the best approach for you, considering any potential risks or interactions with other treatments you may be using.

If you or a loved one is an older adult, make sure to keep your healthcare team informed about all medications and health conditions to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests, which help assess how well your kidneys are working. If your creatinine clearance (a measure of kidney function) falls below a certain level, a reduced dose of your medication may be necessary. Additionally, if you have significant renal impairment, special monitoring will be required to ensure your safety and the effectiveness of your treatment. Always discuss any concerns with your healthcare provider to ensure the best care for your condition.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, always keep it tightly sealed when not in use. Store it in a cool, dry place at a temperature between 20 to 25º C (68 to 77º F). This temperature range helps maintain the product's effectiveness and integrity.

When handling the product, make sure to do so in a clean environment to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is EXCAUGH?

EXCAUGH is an expectorant containing guaifenesin, which helps loosen phlegm (mucus) and thin bronchial secretions.

What are the indications for using EXCAUGH?

EXCAUGH is indicated to help loosen phlegm and thin bronchial secretions, making coughs more productive and ridding the bronchial passageways of bothersome mucus.

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

Adults and children 12 years of age and over should take 2 to 4 tablets every 4 hours, not exceeding 24 tablets (2,400 mg) in 24 hours.

What is the recommended dosage for children aged 6 to under 12?

Children aged 6 to under 12 years should take 1 to 2 tablets every 4 hours, not exceeding 12 tablets (1,200 mg) in 24 hours.

What should I do if my cough persists?

You should stop using EXCAUGH and ask a doctor if your cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.

Are there any contraindications for EXCAUGH?

No specific contraindications are mentioned for EXCAUGH in the provided information.

What should I do if I am pregnant or breastfeeding?

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

How should EXCAUGH be stored?

EXCAUGH should be kept tightly sealed and stored between 20 to 25º C (68 to 77º F).

Is there any information on side effects?

No specific side effects are listed for EXCAUGH in the provided text.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Excaugh.
Details

Drug Information (PDF)

This file contains official product information for Excaugh, 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 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 doing so, it enhances the productivity of coughs, allowing for more effective expulsion of bothersome mucus.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 to 4 tablets every 4 hours, with a maximum dosage not to exceed 24 tablets (2,400 mg) within a 24-hour period.

For children aged 6 to under 12 years, the recommended dosage is 1 to 2 tablets every 4 hours, ensuring that the total does not exceed 12 tablets (1,200 mg) in a 24-hour timeframe.

It is important for caregivers of children under 6 years of age to consult a healthcare professional before administering this medication.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur, as they may indicate a serious condition: cough persisting for more than one week, recurrent cough, or cough accompanied by fever, rash, or persistent headache.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this medication. It is imperative to advise patients to consult a physician prior to use if they present with any of the following conditions:

  • A persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema.

  • A cough that is accompanied by excessive phlegm (mucus).

  • A high fever.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur:

  • The cough persists for more than one week.

  • The cough tends to recur.

  • The cough is accompanied by fever, rash, or a persistent headache.

These precautions are essential to ensure the safe and effective use of the medication.

Side Effects

Patients should be aware that there are no specific side effects associated with the use of this product. However, it is important to monitor for certain conditions and seek medical advice if they arise.

Patients are advised to stop use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by a fever, rash, or persistent headache. Additionally, individuals should ask a doctor before use if they have a persistent or chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema. A cough accompanied by excessive phlegm (mucus) or a high fever also warrants consultation with a healthcare professional.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

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 Excaugh (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Excaugh.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may take 1 to 2 tablets every 4 hours, with a maximum dosage of 12 tablets (1,200 mg) within a 24-hour period. For children under 6 years of age, it is advised to consult a doctor prior to administration.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 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 may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients to assess their kidney status. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is necessary for patients with significant renal impairment to mitigate potential risks associated with altered drug clearance.

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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

Monitoring should continue until the patient is stable and any potential complications are addressed. Documentation of the incident and the management steps taken is also critical for ongoing patient care and legal considerations.

In summary, while specific overdosage information is not available, healthcare professionals should be prepared to act swiftly and effectively in the event of an overdose, utilizing established protocols and resources to ensure optimal patient outcomes.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

Serious side effects have been reported voluntarily by healthcare professionals and patients through various surveillance programs. Individuals are encouraged to report any serious adverse events to the designated contact number provided for this purpose.

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, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if any of the following symptoms occur, as they may indicate a serious condition: a cough that persists for more than one week, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache.

Additionally, healthcare providers should recommend that patients consult a doctor before using the 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) or if they experience a high fever.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It should be stored at a temperature range of 20 to 25º C (68 to 77º F) to maintain optimal conditions. Proper handling and storage are essential to preserve the quality of the product.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Excaugh, 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 Excaugh, 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.