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Tusnel Pediatric

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Active ingredients
  • Guaifenesin 75 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 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 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 75 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 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 31, 2025
Manufacturer
Llorens Pharmaceutical International Division, Inc.
Registration number
M012
NDC root
54859-604
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

TusnelDMPED is a medication designed to provide temporary relief from coughs caused by minor throat and bronchial irritations, which can occur with the common cold or from inhaled irritants. It works by loosening phlegm (mucus) and thinning bronchial secretions, making your cough more productive. Additionally, TusnelDMPED helps to relieve nasal congestion associated with the common cold, offering you some comfort during your illness.

Uses

You can use this medication to temporarily relieve a cough caused by minor throat and bronchial irritations, which can happen with the common cold or from inhaling irritants. It also helps to loosen phlegm (mucus) and thin out bronchial secretions, making your cough more productive. Additionally, this medication can provide temporary relief from nasal congestion associated with the common cold.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For children aged 6 to under 12 years, you should give them 2 teaspoonfuls (10 mL) every 4 hours, but remember not to exceed 6 doses in a 24-hour period. If your child is between 2 and under 6 years old, the dosage is 1 teaspoonful (5 mL) every 4 hours, also with a maximum of 6 doses in a day.

For children under 2 years of age, it's best to consult a doctor before administering the medication. Always keep track of how many doses your child has taken within a day to avoid giving too much.

What to Avoid

It's important to keep this medication out of reach of children to prevent any accidental ingestion. If you suspect an overdose, please seek medical advice 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 safety is a priority, so if you have any concerns or questions, don't hesitate to reach out to your healthcare provider.

Side Effects

If your child is taking certain medications for depression or other emotional conditions, specifically monoamine oxidase inhibitors (MAOIs), do not use this product while they are on those drugs or for two weeks after stopping them. It's important to consult a doctor before using this medication if your child has 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 your child is taking sedatives, tranquilizers, or other medications for depression. If your child experiences nervousness, dizziness, or trouble sleeping, or if a cough lasts more than seven days or returns with a fever, rash, or persistent headache, stop using the medication and consult a doctor, as these may indicate a more serious issue.

Warnings and Precautions

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

Before using this medication, it's important to check with a doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, a cough with excessive mucus, or a chronic cough related to smoking or lung diseases. Additionally, consult a doctor if your child is taking sedatives, tranquilizers, or other medications for depression.

If your child experiences nervousness, dizziness, or sleeplessness, or if a cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the medication and contact a doctor. In the event of an accidental overdose, seek immediate medical help or contact a Poison Control Center.

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 their original packaging and follow the prescribed dosage to minimize the risk of an overdose. 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 medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. This ensures that you understand any potential risks and can make informed decisions about your health and your baby's well-being. Always prioritize open communication with your healthcare provider regarding any medications you may consider while nursing.

Pediatric Use

You should be cautious when giving this medication to your child. It is not safe to use if your child is currently taking a monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks. Before using this medication, consult your doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a cough with excessive mucus. Additionally, if your child is on sedatives, tranquilizers, or depression medications, it's important to check with a doctor first.

When administering the medication, do not exceed six doses in a 24-hour period. For children aged 6 to under 12 years, the recommended dose is 2 teaspoonfuls (10 mL) every 4 hours. For those aged 2 to under 6 years, the dose is 1 teaspoonful (5 mL) every 4 hours. If your child is under 2 years old, consult a doctor for guidance. If your child experiences nervousness, dizziness, sleeplessness, or if a cough lasts more than 7 days or is accompanied by a fever, rash, or persistent headache, stop use and seek medical advice.

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, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

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

Hepatic Impairment

If you have liver problems, it's important to know that 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 when your child is taking certain medications. Specifically, you should avoid using this medication if your child is currently taking a monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks, as this can lead to serious interactions.

Additionally, if your child is on sedatives, tranquilizers, or medications for depression, it's essential to consult with a healthcare provider before using this medication. Discussing all medications and treatments with a doctor helps ensure your child's safety and well-being.

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 the product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult your doctor before using it. Always keep this medication 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 TusnelDMPED used for?

TusnelDMPED temporarily relieves cough due to minor throat and bronchial irritations from the common cold or inhaled irritants, helps loosen phlegm (mucus), and thins bronchial secretions.

What are the directions for using TusnelDMPED?

Do not exceed 6 doses in 24 hours. For children 6 to under 12 years, take 2 teaspoonfuls (10 mL) every 4 hours; for children 2 to under 6 years, take 1 teaspoonful (5 mL) every 4 hours. For children under 2 years, ask a doctor.

Are there any warnings for TusnelDMPED?

Do not use if your child is taking a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if your child has certain health conditions or is taking other medications.

What should I do if my child experiences side effects?

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

Is TusnelDMPED safe for pregnant or breastfeeding women?

If pregnant or breastfeeding, ask a doctor before use.

How should TusnelDMPED be stored?

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

Packaging Info

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

Packaging configurations for Tusnel Pediatric.
Details

Drug Information (PDF)

This file contains official product information for Tusnel Pediatric, 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 the common cold or inhaled irritants. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive. Additionally, this drug provides temporary relief from nasal congestion resulting from the common cold.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the recommended dosage is 2 teaspoonfuls (10 mL) every 4 hours.

For children aged 2 to under 6 years, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours.

For children under 2 years of age, it is advised to consult a physician before administration.

Healthcare professionals should ensure that the dosing intervals are strictly adhered to and that the total daily dosage does not exceed the specified limits.

Contraindications

There are no specific contraindications associated with this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, it is imperative to seek medical advice or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product for children.

Warnings The use of this product is contraindicated in children who are currently taking monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be administered for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

General Precautions Before using this product, it is advisable to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, a cough with excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, it is important to seek medical advice if the child is concurrently taking sedatives, tranquilizers, or any medications for depression, including MAOIs.

Stop Taking and Call Your Doctor Instructions Parents or guardians should discontinue use and consult a healthcare professional if the child experiences 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 symptoms may indicate a serious underlying condition requiring medical evaluation.

Get Emergency Medical Help Instructions In the event of an accidental overdose, immediate medical attention is necessary. Parents or guardians should seek advice from a healthcare provider or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients with pre-existing conditions. It is contraindicated in children who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks, as this combination can lead to significant health risks.

Before administering this medication, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or a cough that produces excessive phlegm. Additionally, children with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Common adverse reactions that may necessitate discontinuation of the medication include nervousness, dizziness, and sleeplessness. If any of these symptoms occur, it is recommended to stop use and consult a healthcare provider. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache, these may indicate a serious underlying condition, and medical attention should be sought promptly.

Drug Interactions

The use of this medication is contraindicated in patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within the past two weeks, as this may result in serious interactions.

Additionally, caution is advised when considering this medication for children who are concurrently using sedatives, tranquilizers, or antidepressants, including MAOIs. It is recommended that a healthcare professional be consulted prior to use in these cases to evaluate the potential for adverse interactions.

Packaging & NDC

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

Packaging configurations for Tusnel Pediatric.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is essential to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or a cough with excessive phlegm. Additionally, a doctor should be consulted if the child has a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if they are taking sedatives, tranquilizers, or drugs for depression.

If the child experiences nervousness, dizziness, sleeplessness, or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts, use should be discontinued and a doctor should be contacted.

Dosage instructions specify that children aged 6 to under 12 years may take 2 teaspoonfuls (10 mL) every 4 hours, while children aged 2 to under 6 years should take 1 teaspoonful (5 mL) every 4 hours. For children under 2 years of age, a doctor should be consulted for appropriate dosing. The total dosage should not exceed 6 doses in a 24-hour period.

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 potential adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits in these populations, as the effects on fetal outcomes and lactation are not fully established. Healthcare providers should consider individual circumstances and the available data when advising women of childbearing potential regarding the use of this medication during pregnancy and lactation.

Lactation

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

Renal Impairment

There is no specific information available 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 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 clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a doctor before 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 identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. It is noted that these reactions may occur in children using the product.

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. Once opened, the product should be discarded 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 doctor prior to use. It is also important to instruct patients to keep the medication out of reach of children and to seek immediate medical advice or contact a Poison Control Center in the event of an accidental overdose.

Drug Information (PDF)

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

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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.