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Tusnel

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Active ingredients
  • Guaifenesin 400 mg/5 mL
  • Dextromethorphan Hydrobromide 20 mg/5 mL
  • Phenylephrine Hydrochloride 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 ingredients
  • Guaifenesin 400 mg/5 mL
  • Dextromethorphan Hydrobromide 20 mg/5 mL
  • Phenylephrine Hydrochloride 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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
54859-517
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

TusnelDM517 is a medication designed to help you manage symptoms associated with colds. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for your body to drain the bronchial tubes. This can provide temporary relief from nasal congestion and coughing caused by minor irritation in the throat and bronchial area.

Since its effectiveness was established on June 9, 2019, TusnelDM517 has been a helpful option for those looking to alleviate discomfort during cold symptoms.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for your body to drain the bronchial tubes. If you're experiencing symptoms from a cold, such as nasal congestion or a cough caused by minor irritation in your throat and bronchial area, this medication can provide temporary relief.

You can rely on this treatment to alleviate discomfort associated with these common respiratory issues, helping you feel more comfortable as you recover.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully. For adults and children over 12 years of age, you should take 5 mL (which is equivalent to one teaspoonful) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period to avoid any potential risks.

If the patient is a child under 12 years of age, it's essential to consult a doctor before administering the medication. This ensures that the child receives the appropriate dosage and guidance tailored to their specific needs. Always prioritize safety and follow these guidelines closely for 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

You should avoid using this medication if you are currently taking a 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 medication includes an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a cough that produces a lot of mucus. You should also seek medical advice if you experience nervousness, dizziness, or sleeplessness, or if your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, as these may indicate a more serious issue.

Warnings and Precautions

You should not use this product if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication 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 medication includes an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a cough that produces a lot of mucus. You should also check with your doctor if you have a persistent cough related to smoking, asthma, chronic bronchitis, or emphysema.

If you experience nervousness, dizziness, or trouble sleeping, stop using the product and contact your doctor. Additionally, if your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or headache that persists, seek medical advice, as these may be signs of a more serious condition.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this product. Your healthcare provider can help you understand any potential risks and ensure that you make safe choices for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this product. This ensures that you receive personalized advice and understand any potential risks to you or your baby. Always prioritize your health and your infant's well-being by seeking professional guidance.

Pediatric Use

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

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different needs when it comes to medication, so regular check-ins with your doctor can ensure safety and effectiveness.

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 and safety considerations for patients with renal impairment (kidney issues) are not provided.

It's always best to 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 and what steps to take for your safety.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to be cautious about the medications you take together. If you are currently using a monoamine oxidase inhibitor (MAOI), a type of medication often used for depression, or if you have stopped taking one within the last two weeks, you should avoid using this medication. Taking these together can lead to serious interactions that may affect your health.

Always discuss your current medications and any recent changes with your healthcare provider. They can help ensure that your treatment plan is safe and effective, minimizing the risk of harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable 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 container tightly closed when not in use.

Once you open the container, remember to discard any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of your product.

Additional Information

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

FAQ

What is TusnelDM517 used for?

TusnelDM517 helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes, temporarily relieving symptoms occurring with a cold, including nasal congestion and cough due to minor throat and bronchial irritation.

What should I know about taking TusnelDM517?

Do not exceed 6 doses in 24 hours. Adults and children over 12 years should take 5 mL (one teaspoonful) every 4 hours, while children under 12 years should ask a doctor.

Are there any warnings associated with TusnelDM517?

Do not use if you are taking a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI, as this can lead to serious interactions. Consult a doctor if you have certain health conditions like heart disease or diabetes.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience nervousness, dizziness, sleeplessness, or if your cough lasts more than 7 days or occurs with a fever, rash, or headache.

Is TusnelDM517 safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a doctor before using TusnelDM517.

How should I store TusnelDM517?

Store TusnelDM517 at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Tusnel (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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 relief of symptoms associated with respiratory conditions, specifically to help loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes. It provides temporary relief from symptoms occurring with a cold, including nasal congestion and cough due to minor throat and bronchial irritation.

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

Dosage and Administration

The recommended dosage for adults and children over 12 years of age is 5 mL (one teaspoonful) administered every 4 hours as needed. It is important to note that the total number of doses should 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 contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, a cough accompanied by excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache, these symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious warnings include the contraindication of use in individuals currently taking monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to using this product.

Before using this product, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, a cough with excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache that lasts, these may indicate a serious condition requiring medical attention.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination may result in serious interactions that could pose significant health risks. It is essential for healthcare providers to ensure that patients are not concurrently using MAOIs before initiating treatment with this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Tusnel (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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 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 clinical data in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this product. It is important to assess the potential risks and benefits associated with the use of this product during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this product in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

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 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 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 no specific overdosage information is provided, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to using this product. 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

Postmarketing experience has identified several adverse reactions associated with the use of TUSNEL DM. Reports indicate that patients may experience nervousness, dizziness, and sleeplessness. These reactions have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek the advice of a doctor or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should 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 prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor before using this product. It is also important to keep the product out of reach of children. In the event of an accidental overdose, patients should seek medical advice 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.