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Tusnel

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 31, 2025
Manufacturer
Llorens Pharmaceutical International Division, Inc.
Registration number
M012
NDC root
54859-506
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

TusnelSF is a medication designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes, which can happen during 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 some comfort when dealing with the discomfort of a cough associated with respiratory issues.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a cold, this medication can help provide temporary relief. It works by loosening phlegm (mucus) and thinning bronchial secretions, making your coughs more productive. This means that it can help clear out mucus from your airways, making it easier to breathe.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.

Dosage and Administration

When taking this medication, it's important to follow the dosage instructions carefully. For adults and children aged 12 years and older, 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 to avoid potential side effects.

If you are giving this medication to a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to adhere to these guidelines to ensure safe and effective use of the medication.

What to Avoid

You can feel reassured that 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, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware of some important warnings and potential side effects when considering this medication. Do not use it if you are currently taking a prescription 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 contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's advisable 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. You should also stop using the medication and consult a doctor if your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious health issue.

Warnings and Precautions

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

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

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Your health and safety are important, so please take these precautions seriously.

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 unusual 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 that when it comes to medications, it's better to be safe and get help if you have any concerns.

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 and any medications you may consider.

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, and your healthcare team is there to support you.

Drug Interactions

It's important to be cautious when taking certain medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), 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 any medications you are taking with your healthcare provider, including over-the-counter drugs and supplements. This ensures that you can safely manage your treatment and avoid any potential risks. Your health and safety are the top priority, so open communication with your provider is key.

Storage and Handling

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

Once you open the bottle, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

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 TusnelSF used for?

TusnelSF temporarily relieves cough due to minor throat and bronchial irritation, as may occur with a cold, and helps loosen phlegm (mucus) to make coughs more productive.

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

Adults and children 12 years and over should take 2 teaspoonfuls (10 mL) every 4 hours, not exceeding 6 doses in any 24-hour period.

What should I do if I have a cough with too much phlegm?

You should ask a doctor before using TusnelSF if you have a cough that occurs with too much phlegm (mucus).

Are there any warnings for using TusnelSF?

Do not use TusnelSF if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI, as this may lead to serious interactions.

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

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

Is TusnelSF safe to use during pregnancy or breastfeeding?

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

How should I store TusnelSF?

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

Packaging Info

Below are the non-prescription pack sizes of Tusnel (dextromethorphan hbr, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonfuls (10 mL) administered every 4 hours. It is imperative that the total number of doses does not exceed 6 in any 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

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use of this product is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug 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 recommend that patients seek medical advice before using this product if they have 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 7 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 product.

Serious adverse reactions may occur in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is crucial for patients to consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI before using this product.

Common adverse reactions include the need for patients to seek medical advice prior to use if they experience a cough that is accompanied by excessive phlegm (mucus) or if they have a chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are advised to discontinue use and consult a healthcare provider 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 a serious underlying condition that requires medical evaluation.

Drug Interactions

The concomitant use of this medication with prescription 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, as this may result in serious interactions.

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 contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Tusnel (dextromethorphan hbr, 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 for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. 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 healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of several adverse reactions associated with the use of the product. These include dizziness, nausea, and vomiting. Additionally, allergic reactions have been reported, which encompass rash, pruritus, and urticaria. These events were reported voluntarily or identified through surveillance programs.

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 kept tightly closed to maintain its 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 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.