Topcare Tussin Dm Max

Description

TopCare® health Nighttime Cough DM is a maximum strength formulation designed for the relief of cough, itchy throat, and runny nose. This product contains the active ingredients dextromethorphan HBr, a cough suppressant, and doxylamine succinate, an antihistamine. It is intended for adult use in individuals aged 12 years and older. The product is available in a liquid dosage form, with a volume of 4 fluid ounces (118 mL), and features a raspberry, blackberry, and menthol flavor profile.

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.

Additionally, it is indicated for the temporary relief of symptoms associated with hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy and watery eyes, and itching of the nose or throat.

This drug also serves to control the impulse to cough, thereby facilitating sleep.

Dosage and Administration

The dosing of this product should be measured exclusively with the dosing cup provided, which must be kept with the product at all times. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 6 hours, with a maximum of 4 doses within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, it is contraindicated for this population.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used to induce sleep in children, and it is imperative to adhere strictly to the recommended dosage. Consumption of alcoholic beverages is contraindicated, as alcohol, along with sedatives and tranquilizers, may enhance drowsiness and increase the risk of adverse effects.

Warnings and Precautions

The use of this product is contraindicated for inducing sleep in children. It is imperative that healthcare professionals advise patients against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such medication within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Patients should be encouraged to consult with a healthcare provider or pharmacist if they are uncertain whether their prescription includes an MAOI.

Healthcare professionals should exercise caution and recommend that patients seek medical advice prior to using this product if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or any respiratory issues such as emphysema or chronic bronchitis. Additionally, patients with a persistent or chronic cough, particularly those related to smoking, asthma, or emphysema, should also consult a physician. It is advisable for patients to discuss their use of sedatives or tranquilizers with their healthcare provider or pharmacist before initiating treatment with this product.

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 be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. A chronic cough may indicate a more serious underlying condition that requires further evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions include marked drowsiness, which may significantly impair the ability to perform tasks that require alertness, such as driving a motor vehicle or operating machinery. Additionally, excitability has been reported, particularly in children, which may necessitate careful monitoring.

Common adverse reactions may include increased drowsiness, especially when the medication is taken in conjunction with alcoholic drinks, sedatives, or tranquilizers, as these substances can exacerbate this effect.

Patients are advised to stop use and consult a doctor if a 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 medication, patients should seek medical advice if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough associated with excessive phlegm, or any breathing problems such as emphysema or chronic bronchitis. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a healthcare professional prior to use.

It is recommended that patients taking sedatives or tranquilizers discuss their use of this medication with a doctor or pharmacist to ensure safety and minimize the risk of adverse effects.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within two weeks of discontinuing an MAOI. MAOIs are typically prescribed for conditions such as depression, certain psychiatric disorders, or Parkinson's disease.

Additionally, caution is advised when this medication is used in conjunction with sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

The combination of this medication with alcohol, sedatives, or tranquilizers may potentiate drowsiness. Therefore, monitoring for increased sedation is recommended, and dosage adjustments may be necessary based on the clinical response and tolerance of the patient.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product, as it is not intended for this age group. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. Caution is advised when considering the use of this product in pediatric populations.

Geriatric Use

Elderly patients do not have specific recommendations for geriatric use, nor are there dosage adjustments, safety concerns, or special precautions indicated in the prescribing information for Topcare Tussin DM Max. Healthcare providers should consider the general health status and comorbidities of geriatric patients when prescribing this medication, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advisable, given the variability in drug metabolism and sensitivity in 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. 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. 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 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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve the administration of activated charcoal, intravenous fluids, or other interventions based on the clinical presentation.

It is essential for healthcare professionals to remain vigilant and prepared to address potential complications arising from an overdose, ensuring that appropriate measures are taken to safeguard the patient's health.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate instances of marked drowsiness and excitability, particularly in pediatric populations. Additionally, there is a potential for increased drowsiness when the product is taken concurrently with alcohol, sedatives, or tranquilizers. These events have been reported voluntarily or through surveillance programs, contributing to the overall understanding of the product's safety profile.

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 to inform patients that this product should not be used to induce sleepiness in children.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Healthcare providers should encourage patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, returns, 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 must be reminded to adhere strictly to the recommended dosage. They should be made aware that marked drowsiness may occur and that they should avoid consuming 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 encourage patients to consult with a doctor before using this product if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, glaucoma, a cough that produces excessive phlegm, or any breathing issues such as emphysema or chronic bronchitis. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking sedatives or tranquilizers should be advised to consult with a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

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 a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients may experience marked drowsiness; therefore, it is advised to avoid alcoholic beverages. Additionally, the use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating caution when driving or operating machinery. Excitability may occur, particularly in children. Patients should measure the medication only with the dosing cup provided and ensure that the dosing cup is kept with the product.

Drug Information (PDF)

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

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