Theraflu

Description

THERAFLU SEVERE COLD RELIEF SOFT CHEWS are chewable tablets formulated to provide fast relief from cough, sore throat, headache, body aches, and fever. Each tablet contains active ingredients including acetaminophen, which serves as a pain reliever and fever reducer, and dextromethorphan HBr, which acts as a cough suppressant. The product is presented in a quantity of 20 chewable tablets, designed for oral administration. Users are instructed to chew the tablets completely before swallowing. The soft chews are flavored with apple cinnamon.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, sore throat pain, headache, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 chewable tablets every 4 hours, as needed, while symptoms persist. It is imperative that patients do not exceed 10 chewable tablets within a 24-hour period unless specifically directed by a healthcare professional.

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

Healthcare professionals should advise patients to adhere strictly to the prescribed dosage and to avoid taking more than directed.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 12 years of age.

• In individuals with a known allergy to acetaminophen.

• In conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

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 using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk.

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

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Discontinuation of Use Patients should be advised to stop taking this product and consult a doctor if they experience any of the following: worsening fever or fever lasting more than three days, presence of redness or swelling, emergence of new symptoms, worsening pain or cough lasting more than seven days, or recurrence of cough accompanied by rash or headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring prompt medical consultation.

It is recommended that patients stop use and consult a doctor if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms arise, or if pain or cough worsens or lasts more than seven days. A return of cough accompanied by a rash or headache that persists should also prompt medical evaluation.

Patients with liver disease, chronic cough associated with excessive phlegm, or chronic cough due to smoking, asthma, or emphysema should seek medical advice before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

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

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for acetaminophen overdose and associated hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease should consult a healthcare professional before using this product. This recommendation extends to a period of two weeks following the discontinuation of an MAOI, as interactions may still pose risks during this time.

Caution is advised when this product is used in conjunction with warfarin, a blood-thinning agent. The combination may elevate the risk of bleeding complications. Monitoring of coagulation parameters is recommended to ensure patient safety and to adjust warfarin dosage as necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu (acetaminophen, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 chewable tablets every 4 hours. It is important for healthcare professionals to emphasize that prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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, given the lack of targeted data.

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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed 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 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 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is no available information regarding teratogenic or non-teratogenic effects. Additionally, no data is provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin reddening, blisters, and rash. These events have been documented in the context of ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even in the absence of noticeable signs or symptoms, an overdose can pose serious health risks, and timely intervention is crucial.

Storage and Handling

The product is supplied in a container that must be stored at a controlled room temperature of 20-25°C (68-77°F). It is essential to ensure that the seal under the bottle cap, which is imprinted with "SEALED for YOUR PROTECTION," remains intact. If this seal is broken or missing, the product should not be used.

Additional Clinical Information

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

Clinicians should advise patients and caregivers about the oral route of administration. It is important to counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Additionally, the medication should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical for both adults and children, even in the absence of noticeable symptoms. Parents are encouraged to learn about the potential for medicine abuse among teens through resources such as www.StopMedicineAbuse.org.

Drug Information (PDF)

This file contains official product information for Theraflu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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