Tussin Dm Max

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 provides temporary relief from symptoms related to hay fever or other upper respiratory allergies, including itching of the nose or throat, runny nose, itchy and watery eyes, 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. The maximum dosage should not exceed the directed amount, and no more than four doses should be taken within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered using the dosing cup provided, every 6 hours as needed. It is imperative to utilize only the dosing cup included with the product to ensure accurate measurement.

This medication is not indicated 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) 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

Patients should not use this product if they are 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 two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

General precautions should be observed before using this product. Patients should seek medical advice if they have a cough that produces excessive phlegm (mucus), experience difficulty urinating due to prostate gland enlargement, have glaucoma, or suffer from breathing problems or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals taking sedatives or tranquilizers should consult a doctor or pharmacist before use.

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 the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a doctor 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.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions include marked drowsiness, which may occur during use. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery due to the risk of impaired alertness. Additionally, excitability may occur, particularly in children.

Common adverse reactions may include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. In such cases, patients should discontinue use and consult a healthcare professional, as these symptoms could indicate a serious underlying condition.

Patients with specific medical conditions should seek medical advice before using this product. This includes individuals with a cough that produces excessive phlegm, difficulty urinating due to prostate enlargement, glaucoma, or chronic respiratory issues such as asthma, chronic bronchitis, or emphysema. Furthermore, patients currently taking prescription monoamine oxidase inhibitors (MAOIs) or those who have recently stopped taking them within the last two weeks should not use this product.

It is also advisable for patients taking sedatives or tranquilizers to consult with a doctor or pharmacist prior to use to avoid potential interactions.

Drug Interactions

The use of TUSSIN DM MAX NIGHTTIME is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for a period of two weeks following the discontinuation of an MAOI. Co-administration may result in serious interactions.

Caution is advised when TUSSIN DM MAX NIGHTTIME is used concurrently with alcohol, sedatives, or tranquilizers, as these substances may potentiate drowsiness. Patients should be monitored for increased sedation and advised to exercise caution in activities that require full alertness.

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. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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, 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. 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 drug. 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. 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 to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Marked drowsiness and excitability, particularly in children, may occur as non-teratogenic effects. There is no additional information available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has been gathered through voluntary reports and surveillance programs. Healthcare professionals and patients are encouraged to report any undesired reactions or side effects associated with the use of the product. For inquiries or to report such events, individuals may contact 1-888-287-1915.

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 includes 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.

Patients should be encouraged to consult their doctor before using this product if they have a cough associated with excessive phlegm (mucus), difficulty urinating due to prostate gland enlargement, glaucoma, or any breathing problems, including persistent or chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking sedatives or tranquilizers should be advised to seek guidance from their doctor or pharmacist prior to use.

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 inventory management and product safety.

Additional Clinical Information

Patients should be informed 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. Clinicians should advise patients who are pregnant or breastfeeding 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. No further information is available regarding laboratory tests or postmarketing experiences.

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)