Tussnex Fm Severe Cough and Congestion

Description

Tussnex FM is a maximum strength formulation designed for individuals aged 12 and over. It contains dextromethorphan hydrobromide, which serves as a cough suppressant, and guaifenesin, an expectorant that aids in the clearance of mucus. Additionally, the formulation includes phenylephrine hydrochloride, a nasal decongestant that alleviates nasal congestion.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating drainage of the bronchial tubes and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may help patients achieve restful sleep. It also alleviates nasal congestion associated with colds.

Limitations of use include its application solely for symptomatic relief and not as a treatment for underlying conditions.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is imperative that the dosing cup provided is used exclusively for measuring the medication and not for any other products.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should ensure that patients are instructed to adhere strictly to these guidelines to avoid potential overdose and ensure safe administration.

Contraindications

Use is contraindicated in patients who experience nervousness, dizziness, or sleeplessness. Discontinue use and consult a healthcare professional if symptoms do not improve within 7 days, if they are accompanied by fever, or if a cough recurs with a rash or persistent headache, as these may indicate a serious condition. Additionally, do not exceed the recommended dosage.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Healthcare professionals should advise patients to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also consult a healthcare professional before use.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a poison control center immediately.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough recurs or is associated with a rash or persistent headache, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, patients are advised to seek medical attention. A return of cough, particularly if it is associated with a rash or persistent headache, may indicate a serious condition and warrants immediate evaluation by a healthcare provider.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for psychiatric or emotional conditions, as well as for Parkinson's disease. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Tussnex Fm Severe Cough and Congestion (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 12 years.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available 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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified. Additionally, there is no available information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to consult a health professional before using this medication if they are pregnant or breastfeeding. It is important to emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion.

Instruct patients to seek immediate medical assistance or contact a poison control center in the event of an overdose. They should be reminded not to exceed the recommended dosage.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if their symptoms do not improve within 7 days, if they develop a fever, or if their cough returns or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

Healthcare providers should also encourage patients to consult a doctor prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also seek medical advice before using the medication.

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 15-30°C (59-86°F). It is important to note that refrigeration is not permitted for this product. Proper adherence to these storage conditions will help maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is also important to advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a poison control center in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Tussnex Fm Severe Cough and Congestion, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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