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Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
October 28, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
October 28, 2024
Manufacturer
PHARMACY VALUE ALLIANCE LLC
Registration number
M012
NDC root
68016-740
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 Max is a maximum strength medication designed to provide relief from cough and chest congestion. 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 your bronchial tubes.

This product is suitable for individuals aged 12 and over and is formulated to control both cough and mucus without causing drowsiness. If you're dealing with a cold and experiencing discomfort from coughing or chest congestion, Tussin DM Max may help alleviate those symptoms.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a cold, this medication can help provide temporary relief. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for your body to drain the bronchial tubes.

Additionally, this medication can relieve chest congestion and help control both cough and mucus, allowing you to breathe more comfortably.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is 20 milliliters (mL) every 4 hours. However, you should not take more than 6 doses within a 24-hour period. It's important to measure the dose using the dosing cup that comes with the product, and be sure to keep this cup with the medication for future use.

Please note that this product is not intended for children under 12 years of age, so if you have younger children, do not use it for them. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Taking this medication while on an MAOI can lead to serious health risks, so it's crucial to follow these guidelines to ensure your safety.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these symptoms may indicate a serious condition. Additionally, if your cough is associated with excessive mucus or is chronic—such as those related to smoking, asthma, chronic bronchitis, or emphysema—you should also seek medical advice before using this medication.

Warnings and Precautions

If you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, do not use this product. You should also wait at least two weeks after stopping an MAOI before using it. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's important to be aware of your health while using this product. If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the product and contact your doctor. These symptoms could indicate a more serious health issue.

In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking your medication, you should seek medical help immediately.

Signs of an overdose can vary, but they may include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, or if you are unsure about your situation, do not hesitate to contact a healthcare professional or call emergency services for guidance. Your safety is the top priority, so it's always better to err on the side of caution.

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 and any medications you may consider.

Pediatric Use

It’s important to be cautious when considering this medication for children. If your child is under 12 years old, you should not use this product, as it is not intended for their use. For those aged 12 and older, the recommended dosage is 20 mL 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests to ensure your kidneys are working properly. If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to keep track of your health and medication effects. Always discuss any concerns with your healthcare provider to ensure your treatment is safe and effective.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for guidance.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to avoid refrigerating it, as this can affect its effectiveness. When handling the product, make sure to do so in a clean environment to maintain its integrity and safety. Always follow any specific instructions provided for use to ensure optimal results.

Additional Information

You should take this medication orally, with the recommended dose for adults and children aged 12 years and older being 20 mL every 4 hours. If you are under 12 years old, do not use this medication.

If you are pregnant or breastfeeding, consult a healthcare professional before using it. It's important to stop using the medication and contact a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these could indicate a more serious condition. Always keep this medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is Tussin DM Max used for?

Tussin DM Max is used to temporarily relieve cough due to minor throat and bronchial irritation, as well as to help loosen phlegm (mucus) and relieve chest congestion.

What are the active ingredients in Tussin DM Max?

The active ingredients are Dextromethorphan HBr, which acts as a cough suppressant, and Guaifenesin, which is an expectorant that helps loosen mucus.

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

The recommended dosage for adults and children 12 years and over is 20 mL every 4 hours, not to exceed 6 doses in a 24-hour period.

Can children under 12 use Tussin DM Max?

No, Tussin DM Max is not intended for use in children under 12 years of age.

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

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

Are there any warnings associated with Tussin DM Max?

Yes, do not use Tussin DM Max if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if you have a cough with too much phlegm or a chronic cough.

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.

Is it safe to use Tussin DM Max during pregnancy or breastfeeding?

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

How should Tussin DM Max be stored?

Store Tussin DM Max at room temperature and do not refrigerate.

Packaging Info

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

Packaging configurations for Premier Value.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value Max Strength Dextromethorphan HBr and Guaifenesin is a combination formulation designed for the management of cough and mucus associated with respiratory conditions. This product contains Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant. The formulation is provided in a liquid dosage form, with a total volume of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions to facilitate drainage of the bronchial tubes. Additionally, it provides relief from chest congestion and helps control both cough and mucus production.

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

Dosage and Administration

The product should be shaken well before each use. For adults and children aged 12 years and older, the recommended dosage is 20 mL administered every 4 hours as needed. It is important to not exceed 6 doses within a 24-hour period. The dosing should be measured exclusively with the dosing cup provided, 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 uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

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.

Patients should refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A prolonged cough may indicate an underlying serious condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache. A persistent cough could indicate a serious underlying condition that requires medical evaluation.

Additionally, patients should seek medical advice before using this medication if they have a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate a different therapeutic approach or further investigation.

Drug Interactions

The concomitant use of this product with 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 within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Premier Value.
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 adolescents, and its safety and efficacy have not been established in children under 12 years.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 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 may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients regularly. For individuals with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered. Additionally, special monitoring is necessary for patients with severe renal impairment to manage potential risks effectively.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures In the absence of specific antidotes or treatment protocols, the management of overdosage should focus on supportive care and symptomatic relief. Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance tailored to the specific circumstances of the case.

It is imperative that healthcare professionals remain informed about the potential risks associated with overdosage and maintain a high index of suspicion when evaluating patients who may have ingested excessive amounts of the medication.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is not refrigerated. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is not recommended for use in children under 12 years.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. Patients are advised to discontinue use and seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition. Additionally, the medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center (1-800-222-1222) is essential.

Drug Information (PDF)

This file contains official product information for Premier Value, 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 Premier Value, 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.

Learn more in our Editorial Policy

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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.