Tussin Dm Max

Description

This oral solution contains Dextromethorphan HBr, a cough suppressant, and Diphenhydramine Succinate, an antihistamine. It is formulated with a Menthol-Berry flavor and is available in a maximum strength dosage of 8 fluid ounces (237 mL). The product is indicated for individuals aged 12 years and older, providing relief from cough, runny nose, and sneezing. The packaging features a tamper-evident seal; the product should not be used if the safety seal under the cap is broken or missing.

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 provides temporary relief from symptoms related to hay fever or other upper respiratory allergies, including itching of the nose or throat, itchy and watery eyes, runny nose, and sneezing. This medication also aids in controlling the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. For adults and children aged 12 years and older, the prescribed dose is 20 mL, to be measured using the dosing cup provided, administered every 6 hours as needed. It is imperative that no more than 4 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 recommended. Healthcare professionals should ensure that patients understand the importance of not exceeding the directed dosage and utilizing only the dosing cup provided for accurate measurement.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and 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

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 should not be used for at least 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 any of the following conditions: a cough accompanied by excessive phlegm (mucus), glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing issues, including persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should consult a doctor or pharmacist if they are concurrently taking sedatives or tranquilizers.

While using this product, patients may experience marked drowsiness. It is recommended to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can exacerbate drowsiness. Caution is advised when driving a motor vehicle or operating machinery due to the potential for impaired alertness. Additionally, excitability may occur, particularly in children.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Patients should discontinue use and consult a healthcare provider 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.

Side Effects

Patients using this product may experience a range of adverse reactions, which can vary in seriousness and frequency.

Marked drowsiness is a common side effect associated with the use of this product. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for impaired alertness. Additionally, excitability has been reported, particularly in children.

Serious adverse reactions may arise if the product is used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications, which are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease.

Patients should discontinue use and consult a healthcare professional if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before using this product, patients are advised to seek medical guidance if they have a cough accompanied by excessive phlegm, glaucoma, difficulty urinating due to prostate enlargement, or any breathing problems, including persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

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. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease.

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking sedatives or tranquilizers to ensure safe and effective use.

Packaging & NDC

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

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 20 mL, administered every 6 hours using the dosing cup provided.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when prescribing this medication to pediatric patients.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns outlined for this population. Additionally, no special precautions are indicated for geriatric patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and overall health status.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 no specific data available regarding the excretion of this medication in 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should monitor the patient closely and implement appropriate interventions based on the clinical presentation.

In summary, timely medical intervention and appropriate management strategies are vital in addressing the complications arising from an overdose.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include drowsiness and excitability, particularly noted in pediatric populations. Additionally, cases of cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or persistent headache have also been documented.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription contains an MAOI, they should be encouraged to consult their doctor or pharmacist.

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

When using this product, patients should be made aware that marked drowsiness may occur. They should be advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be exercised when driving or operating machinery due to the potential for drowsiness. Additionally, patients should be informed that excitability may occur, particularly in children.

Healthcare providers should recommend that patients consult a doctor before using this product if they have a cough associated with excessive phlegm (mucus), glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing problems, including persistent or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be encouraged to speak with their doctor or pharmacist if they are currently taking sedatives or tranquilizers before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

No additional information is available regarding laboratory tests or postmarketing experience.

Clinicians should be aware that the medication is administered orally, with a recommended dosage of 20 mL every 6 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Patients who are pregnant or breastfeeding are advised to consult a healthcare professional prior to use. Additionally, resources are available for understanding the risks of medicine abuse among teens at www.StopMedicineAbuse.org.

Drug Information (PDF)

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

View product document (PDF)