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Tussi Pres 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
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
November 12, 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
Syrup
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 2011
Label revision date
November 12, 2025
Manufacturer
KRAMER NOVIS
Registration number
M012
NDC root
52083-232
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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If you are a consumer or patient please visit this version.

Drug Overview

TUSSIPRESPEDIATRIC is a medication designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to drain your bronchial tubes. It is commonly used to temporarily relieve symptoms associated with a cold, such as nasal congestion and cough caused by minor irritation in the throat and bronchial area. This can help you feel more comfortable when dealing with these common respiratory issues.

Uses

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

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about these specific risks.

Dosage and Administration

If you or your child are in need of this medication, here’s how to take it safely. For adults and children aged 12 years and older, the recommended dose is 4 teaspoons (20 mL) every 4 hours, but only as needed. If your child is between 6 and 12 years old, they should take 2 teaspoons (10 mL) every 4 hours, also as needed. For younger children aged 2 to under 6 years, the dosage is one pre-measured single dose package, which is 1 teaspoon (5 mL), every 4 hours when necessary.

It's important to remember that children under 2 years should not use this medication at all. Additionally, regardless of age, you should not exceed 6 doses in a 24-hour period to ensure safety. Always follow these guidelines to help manage symptoms effectively.

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

It's important to be aware of potential side effects when using this medication. You should not use it in children under 2 years of age or in children who are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions. If your child has heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, consult a doctor before use.

Be cautious not to exceed the recommended dose. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever, it's essential to stop use and consult a doctor. Additionally, if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious issue. If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication.

Warnings and Precautions

You should not use this medication in children under 2 years old or in children who are taking certain prescription medications called monoamine oxidase inhibitors (MAOIs), which are used for depression or other psychiatric conditions. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist. Additionally, it's important to ask a doctor before using this product 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 or lasts a long time.

Make sure to follow the recommended dosage and stop using the medication if your child experiences nervousness, dizziness, or sleeplessness. If symptoms do not improve within 7 days, or if they are accompanied by a fever, or if a cough lasts more than 7 days or returns with fever, rash, or a persistent headache, contact your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait. Getting prompt assistance can be vital for safety and recovery.

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 this medication. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your doctor regarding your health and any medications you may consider while nursing.

Pediatric Use

You should not give this medication to children under 2 years of age. For children aged 2 to under 6 years, the recommended dose is one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours as needed. For children aged 6 to under 12 years, the dose increases to 2 teaspoons (10 mL) every 4 hours as needed. It's important to follow these guidelines closely and not exceed the recommended dose.

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 that produces a lot of mucus or lasts a long time (like with asthma or chronic bronchitis). If your child experiences nervousness, dizziness, sleeplessness, or if their symptoms do not improve within 7 days or worsen, you should stop use and contact a doctor. These could indicate a more serious health issue.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each individual may respond differently to treatments. Since the insert does not provide any recommended age considerations, dosage adjustments, or safety concerns for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your unique health needs and circumstances.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be cautious when it comes to medications, especially if you or your child are taking certain drugs. For instance, if your child is on a prescription monoamine oxidase inhibitor (MAOI), a type of medication used to treat depression, you should avoid using this drug. Doing so can lead to serious interactions, and it’s also advised to wait at least two weeks after stopping an MAOI before starting this medication.

Always discuss any medications or treatments with your healthcare provider. They can help ensure that you avoid potential risks and manage your health safely.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 15° to 30°C (59° to 86°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality.

When handling the product, be sure to check the packaging carefully. Do not use it if the packet is torn, cut, or opened, as this indicates that it may have been tampered with and could be unsafe. Following these guidelines will help you use the product safely and effectively.

Additional Information

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

FAQ

What is TUSSIPRESPEDIATRIC used for?

TUSSIPRESPEDIATRIC helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes, temporarily relieving symptoms of a cold such as nasal congestion and cough due to minor throat and bronchial irritation.

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years of age and older should take 4 teaspoons (20 mL) every 4 hours, as needed.

What dosage should children aged 6 to under 12 take?

Children aged 6 to under 12 years should take 2 teaspoons (10 mL) every 4 hours, as needed.

What dosage is recommended for children aged 2 to under 6?

Children aged 2 to under 6 years should take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed.

Is TUSSIPRESPEDIATRIC safe for children under 2 years?

No, TUSSIPRESPEDIATRIC should not be used in children under 2 years of age.

What should I do in case of an overdose?

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

Are there any warnings for using TUSSIPRESPEDIATRIC?

Do not use TUSSIPRESPEDIATRIC in children under 2 years or in children taking a prescription monoamine oxidase inhibitor (MAOI). Consult a doctor if your child has certain health conditions, such as heart disease or diabetes.

What should I do if my child's symptoms do not improve?

Stop use and ask a doctor if your child gets nervous, dizzy, or sleepless, if symptoms do not improve within 7 days, or if cough lasts more than 7 days or is accompanied by fever, rash, or persistent headache.

Can I use TUSSIPRESPEDIATRIC if I am pregnant or breastfeeding?

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

How should TUSSIPRESPEDIATRIC be stored?

Store TUSSIPRESPEDIATRIC at controlled room temperature between 15° to 30°C (59° to 86°F) and avoid excessive heat or humidity.

Packaging Info

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

Packaging configurations for Tussi Pres Pediatric.
Details

Drug Information (PDF)

This file contains official product information for Tussi Pres 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 specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 4 teaspoons (20 mL) every 4 hours, as needed. For children aged 6 to under 12 years, the recommended dosage is 2 teaspoons (10 mL) every 4 hours, as needed. Children aged 2 to under 6 years should take one pre-measured single dose package, which contains 1 teaspoon (5 mL), every 4 hours, as needed.

It is important to note that the medication is not recommended for use in children under 2 years of age. Additionally, no more than 6 doses should be taken within a 24-hour period to avoid potential overdose.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

The use of this medication is contraindicated in children under 2 years of age. Additionally, it should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription.

Prior to administration, it is essential 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 an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as asthma, chronic bronchitis, or emphysema.

Caregivers must adhere strictly to the recommended dosage and should not exceed it.

If the child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever, the use of the medication should be discontinued, and a healthcare professional should be consulted. Furthermore, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious underlying condition, warranting immediate medical evaluation.

In the event of an overdose, it is critical to seek emergency medical assistance 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, and caution is advised in specific populations.

This medication is contraindicated in children under 2 years of age and in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. Prior to use, it is essential for patients or caregivers 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 an enlarged prostate gland, or a cough that is productive of excessive phlegm or is chronic, such as that associated with asthma, chronic bronchitis, or emphysema.

Patients should adhere strictly to the recommended dosage, as exceeding this may lead to adverse effects. If a child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever, it is crucial to discontinue use and seek medical advice. Additionally, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires immediate medical attention.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this medication to ensure safety for both the mother and child.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

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 Tussi Pres Pediatric (guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tussi Pres Pediatric.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 to under 6 years, the recommended dosage is one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours as needed. Children aged 6 to under 12 years should take 2 teaspoons (10 mL) every 4 hours as needed. For adolescents and adults aged 12 years and older, the dosage is 4 teaspoons (20 mL) every 4 hours as needed.

It is crucial not to exceed the recommended dose. Prior to use, consultation with a healthcare provider is advised if the pediatric patient has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as asthma, chronic bronchitis, or emphysema.

Parents or caregivers should discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness; if symptoms do not improve within 7 days; or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may affect treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is 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

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 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, gastrointestinal disturbances have been noted, including nausea and vomiting. Central nervous system effects, specifically dizziness and drowsiness, have also been reported.

Patient Counseling

Healthcare providers should advise patients to keep the 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 overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the packet is torn, cut, or opened.

For optimal storage, the product must be kept at a controlled room temperature between 15° to 30°C (59° to 86°F). It is essential to avoid exposure to excessive heat or humidity to maintain product integrity.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Tussi Pres 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 Tussi Pres 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.