Tussin Dm

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 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 every 4 hours as needed. It is imperative that patients utilize only the dose cup provided with the medication to ensure accurate dosing.

The medication is not indicated for use in children under 12 years of age; therefore, healthcare providers should refrain from prescribing it to this population.

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 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, the product should not be used for at least two weeks following the discontinuation of 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 are instructed to discontinue use and contact their healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further 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 following adverse reactions associated with the use of this product.

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 product is contraindicated in such cases, and patients should consult a healthcare professional if they are uncertain whether their prescription contains an MAOI.

Common adverse reactions include the need for caution in patients with specific conditions. Patients experiencing a cough that produces excessive phlegm or those with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product.

Patients are advised to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

For pregnant or breastfeeding patients, it is recommended to seek guidance from a health professional prior to use. Additionally, this product 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 is essential.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 product. For individuals aged 12 years and older, the recommended dosage is 20 mL every 4 hours.

It is important to keep this product out of reach of children. In the event of an overdose, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

Geriatric Use

There is no specific information 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 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 absence of 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 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 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 remain aware of the general signs of overdose, which may include but are not limited to altered mental status, respiratory distress, or cardiovascular instability.

Management of an overdose should be guided by the severity of symptoms and the specific substance involved. Supportive care is often necessary, and healthcare providers should be prepared to implement appropriate interventions based on the clinical presentation of the patient. Continuous monitoring and assessment are vital to ensure patient safety and effective management of the overdose situation.

Nonclinical Toxicology

Animal studies have demonstrated that dextromethorphan does not induce teratogenic effects, as no teratogenic outcomes were observed. Furthermore, there was no increase in fetal malformations noted in these studies, indicating a lack of non-teratogenic effects as well. Overall, the findings from animal pharmacology and toxicology suggest that dextromethorphan does not lead to adverse developmental outcomes.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

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 more 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).

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 the route, method, and frequency of administration.

Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately. Additionally, parents are encouraged to learn about teen medicine abuse through resources such as www.StopMedicineAbuse.orgwww.StopMedicineAbuse.org.

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)