Theraflu Severe Cold Relief Daytime Honey Ginger

Description

Acetaminophen serves as a pain reliever and fever reducer, while dextromethorphan HBr functions as a cough suppressant. This formulation is designed for hot liquid therapy, effectively alleviating symptoms such as cough, sore throat pain, head and body aches, and fever. The product is presented in a honey ginger flavor and is available in a package containing six individual packets.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. The medication is intended for oral administration. For adults and children aged 12 years and older, the recommended dose is one packet every 4 hours as needed, with a maximum of 5 packets within a 24-hour period unless otherwise directed by a healthcare professional.

Children under 12 years of age should not use this medication.

To prepare the dose, the contents of one packet should be dissolved in 8 ounces of hot water. The solution should be sipped while hot, and the entire drink should be consumed within 10 to 15 minutes for optimal effectiveness.

If using a microwave for preparation, the contents of one packet should be added to 8 ounces of cool water. The mixture should be stirred briskly before and after heating, ensuring not to overheat the solution.

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, cough, or nasal congestion lasting more than seven days, or if a cough recurs with a 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 using the product and consult a doctor if they experience worsening fever lasting more than three days, redness or swelling, new symptoms, or if pain, cough, or nasal congestion worsens or persists for more than seven days. A cough that recurs or occurs with a rash or headache lasting longer than expected should also prompt medical evaluation.

Patients with pre-existing liver disease, chronic cough associated with excessive phlegm, or chronic cough due to smoking, asthma, or emphysema should consult a doctor before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare professional 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 medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu Severe Cold Relief Daytime Honey Ginger (acetaminophen, dextromethorphan hbr). 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 dosages or safety profiles for this age group, and its use is contraindicated in children below this age.

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.

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 or nursing infant.

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 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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use of other medications containing acetaminophen should be avoided to prevent unintentional overdose.

• Consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may significantly increase the risk of liver damage.

Before initiating treatment, patients with known liver disease are advised to consult their healthcare provider. Monitoring of liver function may be warranted in these individuals 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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

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

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

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

Patients should be informed that this medication is not recommended for use in children under 12 years of age. Additionally, it is essential to avoid using this product if the patient has a known allergy to acetaminophen or if they are currently taking any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of their medications, they should be encouraged to consult with a doctor or pharmacist.

Healthcare providers should also caution patients against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Patients should be advised to inquire with their healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if their fever worsens or persists for more than three days, if they experience redness or swelling, or if new symptoms arise. They should also be advised to stop using the medication if pain, cough, or nasal congestion worsens or lasts longer than seven days. Furthermore, patients should be informed that a returning cough or one that occurs with a rash or persistent headache may indicate a serious condition, warranting medical attention.

Before using this medication, patients with liver disease should consult their healthcare provider. Additionally, those experiencing a cough accompanied by excessive phlegm, or a chronic cough related to smoking, asthma, or emphysema, should seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be encouraged to discuss their use of this product with their doctor or pharmacist.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from heat and moisture to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should be informed that the medication is administered orally and should be taken every 4 hours as needed while symptoms persist. It is important not to exceed 5 packets in a 24-hour period unless directed by a healthcare professional. Clinicians may also refer to resources such as www.StopMedicineAbuse.org to educate themselves and their patients about the potential for medicine abuse, particularly among teenagers.

Drug Information (PDF)

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

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