Basic Care Tussin Cf Severe

Description

Tussin CF Severe Multi-Symptom Cough Cold + Flu is a liquid formulation designed for the relief of multiple symptoms associated with colds and flu. The active ingredients include Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. This product effectively alleviates cough, fever, sore throat, body aches, nasal congestion, and chest congestion.

The formulation is non-drowsy and is intended for use by individuals aged 12 years and older. It is presented in a raspberry flavor and is packaged in an 8 FL OZ (237 mL) bottle, which includes a dosage cup for accurate measurement.

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 at all times 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.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

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

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 within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while taking this product. It is crucial to monitor patients for signs of liver dysfunction, especially in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must 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 without delay.

General Precautions Healthcare professionals should advise 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 cough associated with excessive phlegm. Additionally, patients with persistent or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before use. It is important 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 essential. 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 be advised to 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 who exceed 4,000 mg of acetaminophen within a 24-hour period, 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.

Participants experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional 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 longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is observed; 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 with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, those with a cough that produces excessive phlegm or 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 immediately apparent.

Drug Interactions

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

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain treatments 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.

Co-administration with any other product containing acetaminophen, whether prescription or over-the-counter, is not recommended. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare professional if uncertain.

Packaging & NDC

Below are the non-prescription pack sizes of Basic Care Tussin Cf Severe (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 product, as it is not intended for this age group. For patients 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 seeking prompt medical attention for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not require specific dosage adjustments or special precautions when using BASIC CARE TUSSIN CF SEVERE, as the prescribing information does not indicate any safety concerns or recommendations tailored for this population. However, healthcare providers should remain vigilant and monitor for any potential adverse effects, as individual responses to medication can vary among geriatric patients. It is advisable to consider the overall health status and concurrent medications of elderly patients when prescribing this medication.

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 medication 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 should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 all cases of suspected overdose be treated as medical emergencies, necessitating thorough evaluation and appropriate therapeutic measures.

Monitoring and supportive care may be required, depending on the specific circumstances and clinical presentation of the patient.

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 that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not permitted. Proper storage conditions must be maintained to ensure 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. 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 doctor or pharmacist before use. Pregnant or breastfeeding individuals are also advised to consult a healthcare professional prior to administration.

Drug Information (PDF)

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

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