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Tussi Pres

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Active ingredients
  • Guaifenesin 200 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
  • Phenylephrine Hydrochloride 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 200 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
  • Phenylephrine Hydrochloride 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
52083-231
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Drug Overview

Tussi Pres 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, making it easier for your body to drain the bronchial tubes.

If you're dealing with a cold, it can also temporarily relieve symptoms such as nasal congestion and a cough caused by minor irritation in your throat and bronchial area. This means you can find some comfort while your body fights off the cold.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 teaspoons (10 mL) every 4 hours. If you are giving this medication to children between the ages of 6 and under 12, the appropriate dose is 1 teaspoon (5 mL) every 4 hours.

Make sure not to exceed 6 doses in any 24-hour period, regardless of your age. If your child is under 6 years old, this medication should not be used. Always measure the doses carefully to avoid taking 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, seek medical assistance immediately or contact a Poison Control Center for help.

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 please follow these guidelines carefully.

Side Effects

You should be aware of some important warnings and potential side effects when using this medication. Avoid using it if you are currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. Before using this medication, consult your doctor if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a chronic cough.

If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or are accompanied by a fever, you should stop using the medication and consult your doctor. Additionally, if your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, seek medical advice, as these may indicate a more serious condition. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. In case of accidental overdose, seek medical help immediately or contact a Poison Control Center.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or if you have stopped taking an MAOI within the last two weeks. If you are unsure whether your medication contains an MAOI, please consult your doctor or pharmacist before using this product.

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 or lasts a long time, especially if you have a history of smoking, asthma, chronic bronchitis, or emphysema. Always follow the recommended dosage and do not exceed it.

You should stop using this product and contact your doctor if you experience nervousness, dizziness, or sleeplessness, if your symptoms do not improve within 7 days, or if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious condition. If you are pregnant or breastfeeding, consult a healthcare professional before use. In case of accidental overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an accidental overdose, it’s important 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.

Don’t wait to see if symptoms improve; getting prompt assistance can be crucial. Always prioritize your health and safety by reaching out for help as soon as you have concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When it comes to using this medication for children, it's important to follow specific guidelines. For children aged 6 to under 12 years, you can give them 1 teaspoon (5 mL) every 4 hours as needed. However, if your child is under 6 years old, you should not use this medication at all. Always consult with your child's healthcare provider if you have any questions or concerns about their treatment.

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 best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments or monitoring for renal impairment (kidney issues). This means that there are no tailored guidelines for how the medication should be adjusted based on your kidney function.

Since kidney health can affect how medications work in your body, it's crucial to discuss your individual situation with your healthcare provider. They can help determine the best approach for your treatment, considering your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when taking TUSSI PRES, especially if you are currently using or have recently stopped a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often used to treat depression. Using TUSSI PRES while on an MAOI or within two weeks of stopping it can lead to serious interactions that may affect your health.

Always discuss any medications you are taking, including over-the-counter drugs like TUSSI PRES, with your healthcare provider. They can help ensure that your treatment is safe and effective, and they can provide guidance on managing any potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the security seal is intact before use; do not use it if the seal is torn, broken, or missing. For proper storage, keep the product at a controlled room temperature between 15-30°C (59-86°F) and protect it from excessive heat and humidity, as these conditions can affect its quality.

When handling the product, make sure to do so in a clean environment to maintain its integrity. 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, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Tussi Pres used for?

Tussi Pres 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 over 12?

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

What is the dosage for children aged 6 to under 12?

Children aged 6 to under 12 years should take 1 teaspoon (5 mL) every 4 hours.

Is Tussi Pres safe for children under 6?

No, Tussi Pres should not be used in children under 6 years of age.

What should I do in case of an accidental overdose?

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

Are there any warnings for using Tussi Pres?

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

What should I do if I experience side effects?

Stop using Tussi Pres and ask a doctor if you feel nervous, dizzy, or sleepless, if symptoms do not improve within 7 days, or if you have a cough that lasts more than 7 days.

Can I use Tussi Pres if I am pregnant or breastfeeding?

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

How should Tussi Pres be stored?

Store Tussi Pres at controlled room temperature between 15-30°C (59-86°F) and avoid excessive heat and humidity.

Packaging Info

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

Packaging configurations for Tussi Pres.
Details

Drug Information (PDF)

This file contains official product information for Tussi Pres, 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, including nasal congestion and cough due to minor throat and bronchial irritation. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for temporary relief of symptoms and is not a cure for colds or other underlying conditions.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 teaspoons (10 mL) every 4 hours as needed. For children aged 6 to under 12 years, the recommended dosage is 1 teaspoon (5 mL) every 4 hours. It is important to note that no more than 6 doses should be administered within a 24-hour period. The product is not recommended for use in children under 6 years of age.

Healthcare professionals should ensure that patients are aware of the maximum dosage limits and the appropriate dosing intervals to prevent potential overdose.

Contraindications

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

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is also advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a prescribed medication.

Prior to using this product, it is essential for patients to consult a healthcare provider if they have 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. Additionally, individuals with a chronic cough resulting from smoking, asthma, chronic bronchitis, or emphysema should seek medical advice before use.

Patients must adhere strictly to the recommended dosage and should not exceed the prescribed amount.

If any of the following symptoms occur, it is imperative to discontinue use and consult a healthcare professional: feelings of nervousness, dizziness, or sleeplessness; if symptoms do not improve within seven days or are accompanied by fever; or if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition.

For individuals who are pregnant or breastfeeding, it is crucial to seek guidance from a healthcare professional before using this product.

In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 individuals with specific pre-existing conditions. It is contraindicated for patients taking prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, as this may lead to severe interactions.

Patients with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing urinary difficulties due to an enlarged prostate gland should consult a healthcare professional before using this medication. Additionally, individuals with a cough that produces excessive phlegm or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

Common adverse reactions may include feelings of nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare provider if these symptoms occur, if symptoms do not improve within seven days, or if they are accompanied by fever. Furthermore, if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, it may indicate a serious underlying condition that requires medical attention.

In the event of an accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center. Pregnant or breastfeeding individuals should also consult a healthcare professional before using this medication to ensure safety for both the mother and child.

Drug Interactions

The concomitant use of TUSSI PRES with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This combination may result in serious interactions that could pose significant health risks. It is advised that TUSSI PRES not be administered to patients currently taking an MAOI or within two weeks following the discontinuation of an MAOI. Monitoring for adverse effects is recommended in patients who may have recently ceased MAOI therapy.

Packaging & NDC

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

Packaging configurations for Tussi Pres.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1 teaspoon (5 mL) every 4 hours. The use of this medication is not recommended for children under 6 years of age due to safety concerns.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments or monitoring provided in the prescribing information. Therefore, healthcare professionals should exercise caution when considering treatment for patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 prescribing information.

Overdosage

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

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 in patients using TUSSI-PRES. These reactions include nervousness, dizziness, sleeplessness, rash, and persistent headache. The occurrence of these reactions has been documented, although the relationship to TUSSI-PRES has not been established.

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 accidental overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action in such situations.

Storage and Handling

The product is supplied in packaging that includes a security seal. It is imperative that the product not be used if the security seal is torn, broken, or missing.

For optimal storage, the product should be maintained at a controlled room temperature between 15-30°C (59-86°F). It is essential to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

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, 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, 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

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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.