Tussnex Fm Cold, Flu and Sore Throat

Description

Maximum strength Tussnex FM is formulated to provide relief from symptoms associated with cold, flu, and sore throat. This combination product contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. The formulation is designed to calm headache and fever, soothe cough, thin and loosen mucus, and relieve nasal and chest congestion. It is indicated for use in individuals aged 12 years and older.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, minor aches and pains, sore throat, headache, and fever. Additionally, it temporarily promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating more productive coughs.

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 to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should instruct patients to measure the dose only with the dosing cup included with the product and to avoid using this cup with any other products to prevent dosing errors. Additionally, patients should be cautioned against exceeding the directed dosage, as an overdose may pose significant health risks.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, due to the potential for serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients to avoid exceeding 6 doses within a 24-hour period, as this is the maximum daily amount. Additionally, patients should not use this product in conjunction with other medications containing acetaminophen, nor should they consume 3 or more alcoholic drinks daily while using this product.

In cases of severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider promptly.

This product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to consult a doctor or pharmacist if they are uncertain about the acetaminophen content of their medications.

• Use in children under 12 years of age.

• Use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Patients should seek clarification from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Healthcare professionals should advise patients to seek medical advice before using this product if they have any of the following conditions:

• Liver disease

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Difficulty urinating due to an enlarged prostate gland

• Persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema

• Cough accompanied by excessive phlegm (mucus)

Patients taking the anticoagulant warfarin should consult a doctor or pharmacist prior to using this product.

When using this product, it is imperative that patients adhere strictly to the recommended dosage. They should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

For pregnant or breastfeeding patients, it is essential to consult a healthcare professional before use. Additionally, this product should be kept out of reach of children.

An overdose of this product can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact with a poison control center should be made without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed six doses in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, if a patient experiences a severe sore throat that persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a doctor promptly.

This product is contraindicated for use in children under 12 years of age, in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should also seek medical advice before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional prior to use. Patients taking the blood-thinning medication warfarin should also seek advice from a doctor or pharmacist before using this product.

While using this product, patients must adhere strictly to the recommended dosage. They should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

For pregnant or breastfeeding patients, it is advised to consult a health professional before use. It is crucial to keep this product out of reach of children. An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a poison control center is recommended, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

Additionally, this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing such treatment. The interaction may lead to serious adverse effects, including hypertensive crises, and requires a minimum washout period of two weeks after stopping the MAOI before initiating this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Tussnex Fm Cold, Flu and Sore Throat (acteaminophen, 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 use this medication. For patients aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided. Safety and efficacy have not been established in children under 12 years.

Geriatric Use

Elderly patients should be aware that this medication is not indicated for use in children under 12 years of age. Prior to initiating treatment, it is essential for geriatric patients to consult with a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties related to an enlarged prostate gland.

Additionally, it is advisable for elderly patients to seek guidance from a doctor or pharmacist before using this medication if they are concurrently taking the anticoagulant warfarin, as potential interactions may necessitate careful monitoring or dosage adjustments.

It is important to note that exceeding the recommended dosage may lead to liver damage, which underscores the necessity for prompt medical attention in the event of an overdose. This caution applies to both adults and children, even in the absence of noticeable signs or symptoms. Therefore, vigilant adherence to dosing guidelines is particularly critical in the geriatric population to mitigate the risk of adverse effects.

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 on the excretion of this drug 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 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 should consult a healthcare professional prior to using this product. The presence of liver disease may necessitate special considerations regarding the use of this medication.

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 6 doses within a 24-hour period is exceeded. Additionally, patients should be cautious about concurrent use of other medications containing acetaminophen, as well as the consumption of 3 or more alcoholic drinks daily while using this product, as these factors can further increase the risk of liver damage.

In the event of an overdose, which is defined as taking more than the recommended dose, patients may experience liver damage. Immediate medical attention is essential in cases of overdose, and individuals should seek help or contact a poison control center without delay. This is critical for both adults and children, even if no signs or symptoms of overdose are apparent. Monitoring liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this product.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a poison control center without delay. Quick intervention is crucial, as the risk of liver damage can escalate rapidly, affecting both adults and children. Notably, symptoms may not be immediately apparent; therefore, it is essential to act promptly even in the absence of observable signs.

Healthcare professionals should ensure that patients and caregivers are aware of the importance of seeking medical help in the case of an overdose, reinforcing that timely management can be critical in mitigating potential harm.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, reports of pain, nasal congestion, and cough worsening or lasting more than 7 days have been noted. Instances of fever worsening or persisting beyond 3 days, as well as redness or swelling, have also been documented. New symptoms occurring, along with cough returning or occurring in conjunction with rash or persistent headache, may indicate a serious condition.

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 for patients to understand the potential risks associated with the use of this product during these sensitive periods.

Providers should emphasize the necessity of keeping the medication out of reach of children to prevent accidental ingestion. This precaution is vital for ensuring the safety of young patients.

Additionally, healthcare providers must inform patients about the risks of overdose. Patients should be made aware that taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a poison control center immediately. Quick medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

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, as the product must not be exposed to temperatures outside the specified range. Proper handling and storage conditions are essential to maintain the integrity 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, using the dosing cup provided. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding and to keep the medication out of reach of children.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tussnex Fm Cold, Flu and Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)