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Topcare Tussin Dm

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Active ingredients
  • Guaifenesin 200 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
November 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 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
November 8, 2024
Manufacturer
Topco Associates LLC
Registration number
M012
NDC root
76162-600
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 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 temporarily alleviate coughing caused by minor throat and bronchial irritation, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain your bronchial tubes.

This non-drowsy formulation is suitable for individuals aged 12 and over and is available in a pleasant raspberry flavor. Tussin DM is particularly useful when you're dealing with a cold and need relief from both cough and mucus.

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 reducing the urge to cough, making it easier for you to feel comfortable.

Additionally, this medication helps to loosen phlegm (a thick mucus) and thin out bronchial secretions. This action aids in draining your bronchial tubes, which can help you breathe more easily.

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 each 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 are medications often prescribed for depression, psychiatric 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 precaution is crucial to prevent serious interactions and ensure your safety. Always prioritize your health by seeking professional advice when in doubt.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. Do not use it 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.

Before using this medication, consult 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 fever, rash, or a persistent headache, stop using the medication and seek medical advice, as these could be signs of a more serious condition. In case of an overdose, it is crucial to get medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 your cough is chronic, such as from smoking, asthma, chronic bronchitis, or emphysema. If your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a 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 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 or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Do not wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and well-being.

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 medication for children. If your child is under 12 years old, you should not use this product, as it is specifically not intended for them. For those aged 12 and older, the recommended dosage is 20 mL every 4 hours. Always ensure that you follow these guidelines to keep your child safe and healthy.

Geriatric Use

If you are an older adult or caring for one, it's important to know that this medication is not suitable for children under 12 years old. Before using it, you should consult with a doctor, especially if there are any existing medical conditions. Older adults may be more sensitive to side effects, so it's crucial to discuss any health concerns with a healthcare professional.

Additionally, dosage adjustments might be needed for older patients because kidney function can decrease with age. This means that your doctor may recommend a lower dose to ensure safety and effectiveness. Always follow your healthcare provider's guidance to ensure the best care.

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 you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 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

No further information is available.

FAQ

What is Tussin DM used for?

Tussin DM is used to temporarily relieve cough and chest congestion due to minor throat and bronchial irritation, often associated with a cold.

What are the active ingredients in Tussin DM?

Tussin DM contains Dextromethorphan HBr as a cough suppressant and Guaifenesin as an expectorant.

Who can use Tussin DM?

Tussin DM 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 using 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.

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.

Can I use Tussin DM if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Tussin DM.

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 Topcare Tussin Dm (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topcare Tussin Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TopCare® health is a cough and chest congestion formulation that compares to the active ingredients found in Robitussin® Cough + Chest Congestion DM. This product is designed for adult use and is suitable for individuals aged 12 years and older. Each 4 fluid ounce (118 mL) bottle contains a raspberry flavor. The formulation includes dextromethorphan HBr, a cough suppressant, and guaifenesin, an expectorant, which work together to relieve cough and mucus. This product is non-drowsy, making it appropriate for use during the day.

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.

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 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 product 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

Do not use this product if currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is contraindicated for use within 2 weeks after discontinuing an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

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 the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by additional 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 the use of this medication. Serious warnings include the contraindication of use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease.

Patients are advised to consult a healthcare professional prior to use if they experience a cough that is productive with excessive phlegm or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

It is crucial for patients to discontinue use and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by additional 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, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 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 confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Topcare Tussin Dm.
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. This product is specifically formulated for adults and children 12 years and older, and its safety and efficacy have not been established in younger populations.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects when using this product. It is advisable for healthcare providers to assess the medical conditions of geriatric patients prior to administration, as these individuals may have unique health considerations that could affect their response to treatment.

Additionally, dosage adjustments may be necessary for elderly patients, particularly due to the potential for reduced kidney function in this population. Careful monitoring of renal function is recommended to ensure safe and effective use of the product in geriatric patients.

This product is not intended for use in children under 12 years of age, and its application in elderly patients should be approached with caution, taking into account their overall health status and any existing medical conditions.

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 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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.

Patients should be informed that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious underlying condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Topcare 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 Topcare 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.