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Tussin

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Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
November 5, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
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 2018
Label revision date
November 5, 2024
Manufacturer
H E B
Registration number
M012
NDC root
37808-639
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Tussin is a medication designed to help relieve cough, mucus, and chest congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain your bronchial tubes. This non-drowsy formula is suitable for adults and individuals aged 12 and over, providing temporary relief from cough caused by minor throat and bronchial irritation, such as that which may occur with a cold.

With its maximum strength formulation, Tussin aims to provide effective relief when you need it most, helping you feel more comfortable and breathe easier.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially during a cold, this medication can provide temporary relief. It works by soothing your throat and helping to ease the discomfort associated with coughing.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to clear out mucus from your airways. This can be particularly helpful when you're feeling congested and need to drain your bronchial tubes effectively.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully. For adults and children aged 12 years and older, you should take 20 milliliters (mL) every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period. To ensure accurate dosing, always use the dosing cup that comes with the product, and keep it handy for future use.

Please note that this medication is not suitable for children under 12 years of age, so do not give it to younger children. By following these guidelines, you can use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric, or emotional conditions, or Parkinson’s disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, it's important to consult with your doctor or pharmacist before using this product.

Taking this medication while on an MAOI can lead to serious health risks, so please prioritize your safety by following these guidelines closely.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these symptoms may indicate a serious condition. Additionally, if your cough is associated with excessive mucus or is chronic—such as those related to smoking, asthma, chronic bronchitis, or emphysema—you should seek medical advice before using this product.

Warnings and Precautions

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

It's important to be aware of your health while using this product. If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, stop using the product and contact your doctor. These could be signs of a more serious condition.

In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

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

It’s important to be cautious when considering this medication for children. If your child is under 12 years old, you should not use this product, as it is specifically not intended for that age group. For those who are 12 years and older, the recommended dosage is 20 mL every 4 hours.

Always consult with a healthcare professional before giving any medication to ensure it is safe and appropriate for your child's specific needs.

Geriatric Use

You can feel reassured that there are no specific dosage adjustments or safety concerns for older adults when using this product. It is designed for adults and children aged 12 years and older, and the information provided does not indicate any special precautions for elderly patients.

Since there are no specific warnings or age considerations mentioned for geriatric use, you can use this product as directed without additional concerns. However, it's always a good idea to consult with a healthcare professional if you have any questions or if you are managing other health conditions.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively, which can affect how well it works for you. Your healthcare provider will monitor your kidney function regularly, especially by checking your creatinine clearance levels (a measure of how well your kidneys are filtering waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have severe kidney impairment, your doctor will take extra care in managing your treatment plan. Always communicate openly with your healthcare team about your kidney health to ensure the best outcomes.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. Because of this, you may need to have your dosage adjusted to ensure safety and effectiveness. It's also crucial for your healthcare provider to monitor you closely for any side effects while you're on treatment.

Before starting any medication, your doctor will likely conduct liver function tests (which check how well your liver is working) and may continue to do so during your treatment. This helps ensure that any potential issues are caught early and managed appropriately. Always communicate openly with your healthcare team about your liver health to receive the best care possible.

Drug Interactions

It's important to be cautious about drug interactions when considering any new medication. Specifically, you should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before starting this product. If you're unsure whether your current medication includes an MAOI, it's best to consult with your doctor or pharmacist.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this could affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety guidelines provided with the product to ensure safe and effective use.

Additional Information

You should take this medication orally, with adults and children aged 12 and over typically taking 20 mL every 4 hours. However, do not exceed 6 doses in a 24-hour period.

Before using this medication, consult a doctor if you have a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache. If you are pregnant or breastfeeding, it's important to speak with a healthcare professional first. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is Tussin used for?

Tussin is used to temporarily relieve cough due to minor throat and bronchial irritation, as well as to help loosen phlegm (mucus) and thin bronchial secretions.

Who can use Tussin?

Tussin is indicated for adults and children aged 12 years and over. It is not intended for use in children under 12 years of age.

What are the active ingredients in Tussin?

The active ingredients in Tussin are Dextromethorphan HBr, which is a cough suppressant, and Guaifenesin, which is an expectorant.

How should I take Tussin?

Adults and children 12 years and over should take 20 mL every 4 hours, not exceeding 6 doses in a 24-hour period. Use the dosing cup provided to measure.

Are there any contraindications for Tussin?

Do not use Tussin if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last 2 weeks.

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

If your cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, stop use and ask a doctor.

Can I use Tussin if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should Tussin be stored?

Store Tussin at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

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

Packaging configurations for Tussin.
Details

Drug Information (PDF)

This file contains official product information for Tussin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This formulation is a cough and chest congestion relief product, comparable to Robitussin® Maximum Strength Cough + Chest Congestion DM. It contains the active ingredients dextromethorphan hydrobromide, a cough suppressant, and guaifenesin, an expectorant. The product is designed for non-drowsy relief of cough, mucus, and chest congestion. It is intended for use by adults and individuals aged 12 years and older. The dosage form is a liquid, with a volume of 4 fluid ounces (118 mL).

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, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing should be measured exclusively with the dosing cup provided with the product, which should be kept with the product at all times. This formulation is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a doctor if a cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients should seek medical advice before using this medication if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Tussin.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. The product is specifically not intended for use in children under 12 years, and caution should be exercised in this population.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, are included in the general population for this product, which is intended for adults and children aged 12 years and older. The prescribing information does not specify any dosage adjustments or safety concerns unique to geriatric patients. Furthermore, there are no recommended age considerations or specific warnings related to the use of this product in the elderly population.

Healthcare providers should continue to monitor elderly patients as they would for any adult patient, given the absence of specific precautions or modifications indicated in the prescribing information.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health 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 individuals.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their creatinine clearance levels. It is essential for healthcare professionals to monitor renal function regularly in these patients. Special consideration should be given to those with severe renal impairment, as they may be at increased risk for adverse effects. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating careful consideration of dosage adjustments. It is essential that these patients are monitored closely for any adverse effects throughout the course of treatment.

Prior to initiating therapy, liver function tests should be conducted to establish a baseline. Additionally, ongoing monitoring of liver function is recommended during treatment to ensure patient safety and to facilitate timely adjustments to the dosage if required.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and follow-up care.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not permitted for this product. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor if they experience a persistent cough lasting more than 7 days, if the cough returns, or if it is accompanied by fever, rash, or a persistent headache. Additionally, patients who are pregnant or breastfeeding should seek advice from a healthcare professional before 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 at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Tussin, 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 Tussin, 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.