Tussin Dm

Description

No description information is available for the 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

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed 6 doses 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 4 hours as needed. It is imperative that patients utilize only the dosing cup included with the product to ensure accurate measurement.

Children under 12 years of age should not be given this medication.

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 they are 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 is contraindicated for use within 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 a cough that produces excessive phlegm (mucus) or if they experience a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

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

In the event of an overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant interactions.

Common adverse reactions include the persistence of cough beyond 7 days, which may indicate a more serious underlying condition. Patients are advised to discontinue use and consult a healthcare professional if their cough persists, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

Before initiating treatment, patients should seek medical advice if they have a cough that produces excessive phlegm or if they experience a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These conditions may necessitate a different therapeutic approach.

Drug Interactions

The concomitant use of TUSSIN DM with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use TUSSIN DM while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI. This combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for TUSSIN DM. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Dm (dextromethorphan hbr, guaifenesin). 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 4 hours using the dosing cup provided. 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 a Poison Control Center should be contacted without delay.

Geriatric Use

Elderly patients may use TUSSIN DM (dextromethorphan hbr, guaifenesin solution) as the product is indicated for adults and children aged 12 years and older. The prescribing information does not specify any warnings, dosage adjustments, or special precautions for geriatric use.

Healthcare providers should consider the overall health status and concurrent medications of elderly patients when prescribing this medication, as individual responses may vary. Regular 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. 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 the safety of both the mother and the developing fetus.

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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 a range of adverse reactions associated with the use of the product. These include allergic reactions such as rash, pruritus, and urticaria; neurological effects including dizziness, confusion, somnolence, and hallucinations; gastrointestinal disturbances such as nausea and vomiting; and psychological symptoms including agitation. Additionally, respiratory depression, serotonin syndrome, increased blood pressure, tachycardia, and hepatotoxicity have been reported. Anaphylaxis has also been noted as a serious adverse reaction.

The frequency of these adverse reactions is not known, and reports are based on voluntary submissions, which may not accurately reflect the true incidence of these events. Healthcare professionals are encouraged to report any adverse reactions to the FDA to enhance the understanding of the product's safety profile. Other adverse reactions not listed above may also occur.

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 be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

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. Additionally, healthcare providers should recommend that patients seek medical advice before using this product if they have a cough associated with excessive phlegm (mucus) or if they experience a persistent or chronic cough due to smoking, asthma, chronic bronchitis, or emphysema.

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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

For optimal preservation, it is essential to check the end flap of the packaging for the expiration date and lot number. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

Patients should be informed that 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 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, particularly among teenagers, 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)