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Tussin Dm Cough and Chest Congestion

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Active ingredients
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 20 mg/10 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 2025
Label revision date
November 5, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg/10 mL
  • Dextromethorphan Hydrobromide 20 mg/10 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 2025
Label revision date
November 5, 2025
Manufacturer
Safeway, Inc.
Registration number
M012
NDC root
21130-583
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 and chest congestion for individuals 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 coughs more productive.

By controlling cough and relieving chest congestion, TUSSIN aims to provide comfort during cold symptoms, allowing you to breathe easier. This product is alcohol-free, making it a suitable option for those looking for a gentle solution to manage their cough and congestion.

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 reducing the urge to cough.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions. This makes your coughs more productive, allowing you to clear out mucus more effectively.

Dosage and Administration

When taking this medication, if you are an adult or a child aged 12 years and older, you should take 10 mL every 4 hours as needed. However, it’s important not to exceed 6 doses in a 24-hour period to ensure your safety. Always measure your dose using the dosing cup that comes with the product, as this ensures you get the correct amount. Make sure to keep the dosing cup with the medication for easy access.

Please note that this product is specifically designed for adults and children aged 12 and over, so if you are caring for a child under 12 years old, do not use this medication for them. Always follow these guidelines to 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, 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 using this product.

It's important to follow these guidelines to prevent potential 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 monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks.

If your cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, you should stop using the medication and consult a doctor, as these may indicate a more serious issue. 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 medication. In case of an overdose, seek 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. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, 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 fever, rash, or a persistent headache, stop using the product and contact your doctor, as these may 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. 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 err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to reach out for professional assistance. Your health and safety are 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

This product is specifically designed for adults and should not be used in children under 12 years of age. If you have a child who is younger than 12, it is important to avoid using this medication for their safety. Always consult with a healthcare professional if you have questions about appropriate treatments for your child.

Geriatric Use

This medication is designed for adults and is not suitable for children under 12 years old. If you are an older adult or caring for one, it's important to follow the recommended dosage carefully. For those aged 12 and older, the typical dose is 10 mL every 4 hours as needed. Always consult with a healthcare provider to ensure this medication is appropriate for your specific health needs, especially if there are any concerns about kidney function or cognitive changes, which can be more common in older adults.

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 should be used 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 determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

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

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

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should not use this medication. Mixing these drugs can lead to serious interactions that could affect your health.

Always discuss any medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. They can help ensure that your treatment is safe and effective, minimizing the risk of harmful interactions.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25ºC (68-77ºF). It's important not to refrigerate the product, as this can 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. For adults and children aged 12 years and older, the recommended dose is 10 mL every 4 hours. However, this medication is not recommended for children under 12 years of age. Always follow the dosing instructions provided by your healthcare provider.

FAQ

What is TUSSIN used for?

TUSSIN is used to relieve cough and chest congestion for individuals aged 12 and over. It temporarily alleviates cough due to minor throat and bronchial irritation, often associated with a cold.

What are the active ingredients in TUSSIN?

TUSSIN contains DEXTROMETHORPHAN HBr (20 mg), a cough suppressant, and GUAIFENESIN (200 mg), an expectorant that helps loosen phlegm and thin bronchial secretions.

How should I take TUSSIN?

Adults and children 12 years and over should take 10 mL every 4 hours, not exceeding 6 doses in a 24-hour period. Use the dosing cup provided for accurate measurement.

Are there any contraindications for using 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, as this may lead to serious interactions.

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 using TUSSIN and consult a doctor, as these may indicate a serious condition.

Is TUSSIN safe for children under 12?

No, TUSSIN is not intended for use in children under 12 years of age.

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 if I am pregnant or breastfeeding?

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

How should I store TUSSIN?

Store TUSSIN at 20-25ºC (68-77ºF) and do not refrigerate.

Packaging Info

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

Packaging configurations for Tussin Dm Cough and Chest Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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, thereby facilitating more productive coughs.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or respiratory conditions.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 10 mL administered 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.

Healthcare professionals should instruct patients to measure the dosage exclusively with the dosing cup provided with the product. The use of any other dosing device is not recommended, as it may lead to inaccurate dosing. It is advisable to keep the dosing cup with the product to ensure proper measurement.

This formulation is specifically designed for adults and is not intended for use in children under 12 years of age. Therefore, it is crucial to advise against the use of this product in individuals younger than 12 years.

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 use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a cough 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. These symptoms may indicate a more serious underlying condition that requires medical 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 without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, and patients should refrain from using it for at least two weeks after stopping the MAOI.

Common adverse reactions may include a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, and patients are advised to discontinue use and consult a healthcare professional if they experience these signs.

Additionally, patients should seek medical advice before using this medication if they have a cough associated with excessive phlegm or if they have a chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination may result in serious interactions that could pose significant health risks. It is essential for healthcare providers to ensure that patients are not concurrently using MAOIs before initiating treatment with this medication.

Packaging & NDC

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

Packaging configurations for Tussin Dm Cough and Chest Congestion.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children within this age group. Therefore, it is contraindicated for use in individuals under 12 years.

Geriatric Use

Elderly patients may utilize this product; however, it is important to note that it is not intended for use in children under 12 years of age. For adults, including geriatric patients aged 65 and older, the recommended dosage is 10 mL every 4 hours.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as age-related physiological changes may affect drug metabolism and clearance. Close monitoring for efficacy and potential adverse effects is advised in this population to ensure safe and effective use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

Renal Impairment

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

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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 important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a temperature range of 20-25ºC (68-77ºF). It is imperative to avoid refrigeration to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tussin Dm Cough and Chest Congestion, 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 Cough and Chest Congestion, 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.