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Tusnel

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Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
Dosage form
Liquid
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 2019
Label revision date
December 29, 2025
Manufacturer
Llorens Pharmaceutical International Division, Inc.
Registration number
M012
NDC root
54859-507
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

TusnelEX is a medication designed to temporarily relieve coughs caused by minor irritations in the throat and bronchial area, which can occur with a cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive and easier to manage. This can provide you with comfort during times when you are experiencing respiratory discomfort.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritations, such as those that can happen with a cold, this medication can provide temporary relief. It works by soothing your throat and reducing the urge to cough.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions. This makes your coughs more productive, allowing you to clear out mucus more effectively.

Dosage and Administration

When taking this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children over 12 years old, you should take 2 teaspoonfuls (which is 10 mL) every 4 hours. However, make sure not to exceed more than 6 doses in any 24-hour period.

If the patient is a child under 12 years old, it's best to consult a doctor for the appropriate dosage. Always remember to adhere to these guidelines to avoid any potential risks.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always use it responsibly and as directed. Your health and safety are paramount, so please follow these guidelines closely.

Side Effects

You should be aware of some important warnings and potential side effects when using this medication. First, do not take it if you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI.

Before using this medication, consult your doctor if you have a cough that produces a lot of mucus or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could be signs of a more serious condition.

Warnings and Precautions

You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

Before using this medication, it's important to talk to your doctor if you have a cough that produces a lot of mucus, or if you have a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop taking the medication and contact your doctor, as these could be signs of a more serious issue.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

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 potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. 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

If you are considering using this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. This ensures that the treatment is safe and appropriate for their specific age and health needs. Always prioritize your child's well-being by seeking professional advice when it comes to their medication.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious about the medications you take, especially if you are currently using a prescription monoamine oxidase inhibitor (MAOI), a type of antidepressant. You should not use this medication while taking an MAOI or for at least two weeks after stopping it, as this can lead to serious interactions.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potential complications. They can help you understand how different drugs may interact and guide you on the best course of action for your health.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s okay for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the bottle tightly closed when you’re not using it.

Once you open the bottle, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is TusnelEX used for?

TusnelEX temporarily relieves cough due to minor throat and bronchial irritations, such as those that may occur with a cold, and helps loosen phlegm (mucus) to make coughs more productive.

What are the directions for using TusnelEX?

Adults and children over 12 years should take 2 teaspoonfuls (10 mL) every 4 hours, but do not exceed 6 doses in any 24-hour period. For children under 12 years, consult a doctor.

Are there any contraindications for TusnelEX?

There are no specific contraindications listed for TusnelEX, but do not use it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience an overdose?

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

What precautions should I take before using TusnelEX?

Ask a doctor before use if you have a cough with too much phlegm, or if your cough is chronic due to smoking, asthma, chronic bronchitis, or emphysema.

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

Stop using TusnelEX and consult a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

Can I use TusnelEX if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using TusnelEX.

How should I store TusnelEX?

Store TusnelEX at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the bottle tightly closed when not in use.

Packaging Info

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

Packaging configurations for Tusnel.
Details

Drug Information (PDF)

This file contains official product information for Tusnel, 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 temporary relief of cough associated with minor throat and bronchial irritations, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or respiratory conditions.

Dosage and Administration

The recommended dosage for adults and children over 12 years of age is 2 teaspoonfuls (10 mL) administered every 4 hours. It is imperative that the total number of doses does not exceed 6 doses within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should exercise caution and advise patients to seek medical guidance before using this product if they experience a cough that is associated with excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and contact their healthcare provider if a cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication.

Serious adverse reactions may occur in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, and patients should refrain from using it for at least two weeks after stopping the MAOI.

Common adverse reactions include the potential for a cough that may be accompanied by excessive phlegm (mucus). Patients with a chronic cough, such as those suffering from smoking-related conditions, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional before using this medication.

Patients are advised to discontinue use and seek medical attention if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Drug Interactions

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. This precaution is due to the potential for significant interactions that may arise from the concurrent use of these agents.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

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

Packaging configurations for Tusnel.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment in this age group to ensure safety and efficacy.

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. 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. It is essential to evaluate 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 caution is advised to ensure the well-being of both the mother and the fetus.

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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information 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 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, increased severity of known side effects, unusual behavioral changes, or any other atypical 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 supportive care in the event of an overdose.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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