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Berkley and Jensen Tussin Dm

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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 2022
Label revision date
September 24, 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 2022
Label revision date
September 24, 2024
Manufacturer
BJWC
Registration number
M012
NDC root
68391-299
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

TUSSIN DM is a medication designed to help relieve cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to control your cough, and guaifenesin, an expectorant that helps thin and loosen mucus. This combination works to temporarily alleviate cough caused by minor throat and bronchial irritation, such as that which can occur with a cold.

In addition to controlling cough, TUSSIN DM helps to loosen phlegm (mucus) and drain bronchial tubes, making it easier to breathe. It is formulated for adults and is available in a pleasant raspberry and menthol flavor, providing a non-drowsy option for those aged 12 and over.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially from 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 drain the bronchial tubes. This can be particularly helpful when you're feeling congested and need to clear your airways.

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 with the medication for easy access.

Please note that this product is not intended for children under 12 years of age, so do not use it for younger children. By following these guidelines, you can safely manage your dosage and ensure effective use of the medication.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric, or emotional conditions, or for Parkinson’s disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before taking this product.

It's important to follow these guidelines to prevent potential serious interactions and ensure your safety. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, do not use this product, and wait at least two weeks after stopping the MAOI before starting it.

If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these could indicate a more serious condition. Additionally, if you have a cough with excessive mucus or a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, it’s important to talk to your doctor before using this product.

Warnings and Precautions

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

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

In the event of an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

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

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always prioritize safety and open communication when managing medications.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 may affect you 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 about combining medications. 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 using this product. If you're unsure whether your current medication includes an MAOI, please consult your doctor or pharmacist for guidance.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.

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 instructions provided to ensure safe and effective use.

Additional Information

You should take this medication orally, with a recommended dose of 20 mL every 4 hours for adults and children aged 12 and over. However, do not exceed 6 doses in a 24-hour period to avoid potential risks.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is TUSSIN DM used for?

TUSSIN DM temporarily relieves cough due to minor throat and bronchial irritation, as may occur with a cold, and helps loosen phlegm (mucus) to drain bronchial tubes.

What are the active ingredients in TUSSIN DM?

TUSSIN DM contains Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant that thins and loosens mucus.

Who should use TUSSIN DM?

This product is intended for adults and children aged 12 years and over. It should not be used in children under 12 years of age.

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

The recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses in any 24-hour period.

Are there any contraindications for TUSSIN DM?

Do not use TUSSIN DM 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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache, stop use and consult a doctor.

Can I take TUSSIN DM if I am pregnant or breastfeeding?

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

What should I do in case of an overdose?

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

What are the storage instructions for TUSSIN DM?

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

Packaging Info

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

Packaging configurations for Berkley and Jensen Tussin Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Berkley Jensen® Tussin DM is a maximum strength cough and chest congestion formulation designed for adult use. Each 8 fl oz (237 mL) bottle contains a cough suppressant, dextromethorphan HBr, and an expectorant, guaifenesin, which work synergistically to control cough and relieve chest congestion. The product is formulated to thin and loosen mucus, facilitating easier expectoration. It is non-drowsy and suitable for individuals aged 12 and over. The formulation is available in a raspberry and menthol flavor, providing a palatable option for users.

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 over are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

The dosing should be measured exclusively with the dosing cup provided with the product to ensure accuracy. It is recommended to keep the dosing cup with the product at all times to facilitate proper administration.

This product is not intended for use in children under 12 years of age; therefore, it should not be administered to this population.

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 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use 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, the product should not be used for at least 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 seek medical guidance before using this product if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough resulting from conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and contact their healthcare provider if their 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.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or Parkinson’s disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication.

Common adverse reactions may include a persistent cough. Patients are advised to stop use and consult a doctor if their cough lasts 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 product if they have a cough that occurs with excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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, psychiatric disorders, emotional conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of 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 Berkley and Jensen Tussin Dm (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Berkley and Jensen Tussin Dm.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 4 hours. This product is specifically not intended for use in children under 12 years, and caution should be exercised to ensure compliance with this guideline.

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 potential 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 this medication. Consequently, there are no 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing potential overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is vital for healthcare providers to remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

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

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. 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 healthcare professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, patients are advised to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Berkley and Jensen Tussin Dm, 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 Berkley and Jensen Tussin Dm, 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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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.