Tussin Severe Cough Cold Flu

Description

TUSSIN SEVERE COUGH COLD + FLU is a maximum strength formulation designed for adults aged 12 and over. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. This product is presented in a liquid dosage form with a raspberry flavor, packaged in an 8 fl oz (237 mL) bottle. It is free from gluten and alcohol, and is formulated to be non-drowsy. TUSSIN SEVERE COUGH COLD + FLU effectively relieves multiple symptoms, including cough, sore throat, nasal congestion, chest congestion, body aches, and fever.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza. Specifically, it addresses the following symptoms: cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, headache, and fever. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 5 doses are administered within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement; it is essential to keep the dosing cup with the product to ensure proper administration. This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

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

This product should not be used in individuals with a known allergy to it or any of its ingredients, as this may result in severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen in a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor 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, or a cough associated with excessive phlegm. Additionally, patients with persistent or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use. It is also crucial to inquire about concurrent use of warfarin, a blood-thinning medication, as it may interact with acetaminophen.

Emergency Medical Help In the event of an overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent, as prompt intervention is critical for both adults and children.

When to Stop Taking the Product Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or persists beyond 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 with a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness, if pain, cough, or nasal congestion worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, or a cough that occurs with excessive phlegm. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication, due to the potential for increased bleeding risk.

The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a healthcare provider.

This product should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or over-the-counter. Patients are advised to verify the presence of acetaminophen in their other medications by consulting a healthcare professional if there is any uncertainty.

Packaging & NDC

Below are the non-prescription pack sizes of Tussin Severe Cough Cold Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For those aged 12 years and older, the recommended dosage is 20 mL every 4 hours, with a maximum of 5 doses in any 24-hour period.

Healthcare professionals should be aware of the overdose warning, which emphasizes the importance of prompt medical attention for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, do not require specific dosage adjustments or have noted safety concerns associated with the use of this product. The formulation is intended for use in adults and children aged 12 years and older, suggesting that it may not be appropriate for individuals under the age of 12.

While no specific geriatric precautions or recommendations are provided, healthcare providers should remain vigilant in monitoring elderly patients for any potential adverse effects, given the general considerations associated with pharmacotherapy 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 safe use during pregnancy and lactation.

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 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 should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that medical personnel monitor the patient closely and provide supportive care as needed.

In cases of suspected overdose, the following steps should be taken:

1. Assessment: Evaluate the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Initiate appropriate supportive measures, which may include airway management, oxygen supplementation, and intravenous fluids as indicated.

3. Decontamination: If the overdose is recent and the patient is alert, consider activated charcoal administration, provided there are no contraindications.

4. Symptomatic Treatment: Manage any symptoms that arise, tailoring interventions to the specific clinical presentation.

Healthcare professionals are encouraged to remain vigilant and act swiftly to ensure optimal outcomes in cases of overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions reported in postmarketing experience. Symptoms of these reactions may include skin reddening, blisters, and rash. These events have been documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is important for patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Additionally, patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is any doubt regarding the presence of acetaminophen in other medications, patients should seek clarification from their healthcare provider.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Healthcare providers should emphasize the importance of stopping use and seeking medical advice if pain, cough, or nasal congestion worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be advised to consult a doctor if new symptoms arise or if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is also essential for patients to consult their healthcare provider before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

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. It is contraindicated for use in children under 12 years of age.

Clinicians should counsel patients to consult a doctor prior to use 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, or a persistent cough associated with excessive phlegm, smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare professional before use. Pregnant or breastfeeding individuals are also advised to consult a health professional prior to administration.

Drug Information (PDF)

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

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