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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 2014
Label revision date
December 23, 2025
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 2014
Label revision date
December 23, 2025
Manufacturer
Discount Drug Mart
Registration number
M012
NDC root
53943-503
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 temporarily relieve cough caused by minor throat and bronchial irritation, which can occur with a cold. It works by containing two active ingredients: Dextromethorphan HBr, a cough suppressant that helps reduce the urge to cough, 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, providing relief from cough and congestion associated with colds. If you're looking for a way to manage your cough and help clear your airways, Tussin DM may be a helpful option.

Uses

You can use this medication to temporarily relieve a cough caused by minor irritation in your throat and bronchial tubes, which often happens when you have a cold. Additionally, it helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to drain the bronchial tubes. This can provide you with some comfort and relief when you're feeling under the weather.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 2 teaspoonfuls every 4 hours. However, make sure not to exceed 6 doses within a 24-hour period.

If you have children under 12 years old, this medication is not suitable for them, so please avoid using it for that age group. Always remember to measure your doses carefully to avoid taking too much.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it 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.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it’s essential to stop using the product 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 related to smoking, asthma, bronchitis, or emphysema, you should speak with your doctor before taking this medication.

Please note that this product should not be used if the printed seal under the cap is torn or missing, and it is not suitable for children under 12 years of age. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, or if you have stopped taking one within the last two weeks, you should also avoid this medication.

Warnings and Precautions

You should not use this product if the printed seal under the cap is torn or missing. It is also not suitable for children under 12 years of age. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication used for depression, certain psychiatric conditions, or Parkinson's disease—or have stopped taking one within the last two weeks, do not use this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop taking the product and call your doctor, as these symptoms may indicate a more serious condition. In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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. You should not use it in children under 12 years of age. For those who are 12 years and older, the recommended dosage is 2 teaspoonfuls every 4 hours. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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 follow their guidance on dosage and safety to ensure the best outcomes.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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. Additionally, keep the original carton, as it contains important directions for use that you will need.

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Tussin DM used for?

Tussin DM temporarily relieves cough due to minor throat and bronchial irritation, often associated 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, which is a cough suppressant, and Guaifenesin, which is 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 for adults and children 12 years and over is 2 teaspoonfuls every 4 hours, with a maximum of 6 doses in any 24-hour period.

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

You should stop using Tussin DM and consult a doctor if your cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Are there any warnings associated with Tussin DM?

Yes, do not use Tussin DM if the printed seal under the cap is torn or missing, or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Is Tussin DM safe to use during pregnancy or breastfeeding?

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

How should Tussin DM be stored?

Store Tussin DM at 20°-25°C (68°-77°F) and do not refrigerate. Keep the carton for full directions for use.

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

No description information is available for the specified 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, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonfuls administered every 4 hours. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

For children under 12 years of age, the use of this medication is not advised. Healthcare professionals should ensure that patients adhere to the specified dosing guidelines to promote safety and efficacy.

Contraindications

There are no specific contraindications identified 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

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Product Integrity The product must not be used if the printed seal under the cap is torn or missing. This is crucial to ensure the integrity and safety of the medication.

Age Restrictions This product is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not administered to this age group.

Drug Interactions The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is essential to consult a healthcare provider or pharmacist prior to use.

Monitoring for Serious Conditions Patients should be advised to discontinue use and contact their healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt action is critical in managing potential overdose situations effectively.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is contraindicated in individuals with a torn or missing printed seal under the cap. Additionally, it should not be administered to children under 12 years of age. The product is also contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued an MAOI within the past two weeks. Patients uncertain about whether their prescription medication contains an MAOI are advised to consult a healthcare professional prior to use.

Patients are instructed to discontinue use and seek medical advice if their 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.

Before taking this product, patients should consult a healthcare provider if they have a cough associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, bronchitis, or emphysema.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoonfuls every 4 hours. Safety and efficacy have not been established in children younger than 12 years.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 associated with its 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

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.

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 with a doctor before taking the medication if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to conditions such as smoking, asthma, 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 exposed to cold storage conditions. Proper handling and storage 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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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.