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Tussin Dm

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
December 29, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2012
Label revision date
December 29, 2023
Manufacturer
DeMoulas Market Basket
Registration number
M012
NDC root
53942-503
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, particularly for adults aged 12 and over. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to temporarily relieve cough 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 the bronchial tubes.

This non-drowsy formulation is intended to provide relief from symptoms associated with colds, allowing you to feel more comfortable. Tussin DM is marketed as a cost-effective option, comparable to other well-known cough and congestion medications.

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 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 recommended dosage to ensure your safety and effectiveness. You should not take more than 6 doses within a 24-hour period. This limit helps prevent potential side effects and ensures that the medication works as intended. Always keep track of how many doses you've taken throughout the day to stay within this guideline. If you have any questions or concerns about your dosage, be sure to consult with your healthcare provider.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention. Always prioritize your health and seek professional advice when needed.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. It is not recommended for children under 12 years of age. Additionally, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication used for depression or certain other conditions—or have stopped taking one within the last two weeks, you should avoid this product.

If your cough lasts more than seven days, returns, or is accompanied by symptoms like fever, rash, or a persistent headache, it’s important to stop using the medication and consult a doctor, as these could indicate a more serious issue. You should also speak with a healthcare professional before using this product if your cough is producing a lot of mucus or if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Warnings and Precautions

You should not use this medication if you are under 12 years old. Additionally, avoid taking it if you are currently on a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions. If you have recently stopped taking an MAOI, wait at least two weeks before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop taking the medication and call your doctor, as these symptoms may indicate a more serious issue. In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

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 unusual 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 health and safety.

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 is important to note that this medication should not be used in children under 12 years of age. If you are considering this treatment for your child, please ensure they meet the minimum age requirement to avoid any potential risks. Always consult with your healthcare provider for guidance tailored to your child's specific needs.

Geriatric Use

When it comes to using Tussin DM Cough and Chest Congestion, there are no specific guidelines or dosage adjustments for older adults. This means that the standard dosage applies to you just as it does to younger patients. Additionally, there are no unique safety concerns or precautions noted for elderly patients, so you can feel reassured that the medication is considered safe for use in this age group.

As always, it's important to consult with your healthcare provider before starting any new medication, especially if you have other health conditions or are taking other medications. They can provide personalized advice to ensure that Tussin DM is appropriate for your needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

Hepatic Impairment

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

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

Drug Interactions

It's important to be cautious when taking certain medications together. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or other emotional conditions, you should not use this product if you are under 12 years old. Additionally, you should wait at least two weeks after stopping an MAOI before starting this product. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

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 can affect its effectiveness. Make sure to keep the original carton, as it contains the full directions for use, which are essential for safe handling and application.

When handling the product, always follow the instructions provided in the carton to maintain safety and effectiveness. Proper storage and careful handling will help you get the most out of your device.

Additional Information

No further information is available.

FAQ

What is Tussin DM used for?

Tussin DM is used to temporarily relieve cough due to minor throat and bronchial irritation, as may occur with a cold, and helps loosen phlegm (mucus) and thin bronchial secretions.

What are the active ingredients in Tussin DM?

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

Who can use Tussin DM?

Tussin DM is intended for adults aged 12 and over. Do not use it in children under 12 years of age.

Are there any warnings associated with Tussin DM?

Yes, do not use Tussin DM if you are taking a prescription monoamine oxidase inhibitor (MAOI) or if the imprinted shrink band is missing or broken.

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

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

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 is the recommended dosage for Tussin DM?

Do not take more than 6 doses of Tussin DM in any 24-hour period.

How should Tussin DM be stored?

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

Packaging Info

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

Packaging configurations for Tussin Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dextromethorphan HBr and guaifenesin are the active ingredients in this formulation, which serves as a cough suppressant and expectorant. The product is designed to assist in loosening chest congestion. It is specifically formulated for adult use, indicated for individuals aged 12 years and older. The dosage form is a liquid, presented in an 8 fluid ounce (237 mL) container. This formulation is characterized as non-drowsy, making it suitable 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.

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

Dosage and Administration

The recommended dosage for the medication should not exceed 6 doses within a 24-hour period. Healthcare professionals are advised to ensure that patients adhere to this limit to prevent potential overdose and associated adverse effects. It is essential to monitor the timing of each dose to maintain compliance with the prescribed dosing schedule.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

The use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that patients are aware of this restriction to prevent potential adverse effects in younger populations.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease, should not use this product. Additionally, it is essential to refrain from using this medication for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a patient's current prescription, it is advisable to consult a healthcare provider or pharmacist prior to administration.

Patients should be instructed to discontinue use and seek medical advice if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is critical to ensure patient safety and effective management of overdose situations.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is contraindicated in children under 12 years of age. Additionally, patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. Patients uncertain about whether their prescription medication contains an MAOI are advised to consult a healthcare professional before use.

Patients are instructed to stop using the product and seek medical advice if their 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.

Before using this product, patients should consult a healthcare provider if they have a cough that produces excessive phlegm or 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 monoamine oxidase inhibitors (MAOIs) is contraindicated in patients under 12 years of age. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, or Parkinson's disease. This contraindication extends to a period of two weeks following the discontinuation of an MAOI.

Healthcare professionals are advised to ensure that patients are not currently taking or have recently stopped taking an MAOI before prescribing this product. If there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen, it is recommended that the patient consult with a healthcare provider or pharmacist for clarification.

Packaging & NDC

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

Packaging configurations for Tussin Dm.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in younger children is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, safety concerns, or special precautions associated with Tussin DM Cough and Chest Congestion as indicated in the prescribing information. Therefore, healthcare providers may administer this medication to geriatric patients without the need for modifications or additional monitoring specific to this population. However, standard clinical judgment should always be applied when treating elderly patients, considering their overall health status and potential for polypharmacy.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, 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 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 keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should encourage patients to consult a doctor prior to use if they have a cough that is associated with excessive phlegm (mucus). It is also important to advise patients to seek medical advice if they have a cough that is chronic or lasts for an extended period, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a carton that contains essential information for use, which should be retained for reference. It is recommended to store the product at a temperature range of 20‐25 °C (68‐77 °F). Refrigeration is not advised, as the product should not be stored at lower temperatures. Proper handling and storage conditions are crucial to maintain 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 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 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.