Theraflu

Description

NDC 0067-6094-01, THERAFLU POWERPODS DAYTIME SEVERE COLD is a combination product designed for the relief of cold symptoms. Each pod contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. The formulation is enhanced with berry flavors infused with menthol and green tea. The product is packaged in a tamper-evident pouch, with individual sealed pouches to ensure product integrity. It is intended for use exclusively with compatible single-serve brewing machines, including Keurig and Mr. Coffee, although it is not affiliated with either brand. Each package contains 8 pods, and users are advised not to use the product if the pouch is torn or broken, and to open the pouch only at the time of use.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold, including minor aches and pains, minor sore throat pain, headache, nasal and sinus congestion, 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

Adults and children aged 12 years and older are instructed to take one pod every 4 hours as needed while symptoms persist. The maximum dosage should not exceed 5 pods within a 24-hour period unless directed by a healthcare professional.

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

To prepare the beverage, the pod must be placed in a compatible brewer without removing the foil seal, as this is essential for proper functioning and to prevent the risk of burns from hot water. A minimum of 8 ounces of water should be used for brewing.

After brewing, the pod will be hot and may drip; therefore, it is advisable to tilt the pod during removal to minimize dripping. Following use, the pod should be removed, and the brewer should be flushed with at least 8 ounces of water.

The beverage should be sipped while hot and consumed entirely within 10 to 15 minutes for optimal effect.

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.

Additionally, it is important not to exceed the recommended dosage.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they 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 alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

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

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be advised to consult their healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm or is chronic, such as that associated with smoking, asthma, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

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 right away, regardless of whether they exhibit signs or symptoms.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if pain, cough, or nasal congestion worsens or lasts more than seven days. A return of cough accompanied by rash or headache that persists may indicate a serious condition requiring medical 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.

Participants should consult a healthcare provider 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.

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

Before using this product, patients should consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that produces excessive phlegm or is chronic, such as that associated with smoking, asthma, or emphysema.

Patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

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

The use of this medication is also 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 administered for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises.

Patients taking the anticoagulant warfarin should consult with 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 increased bleeding.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. For those aged 12 years and older, the recommended dosage is one pod. Safety and efficacy have not been established in children younger than 12, and therefore, use in this population is contraindicated.

Geriatric Use

There is no specific information regarding the use of THERAFLU POWERPODS DAYTIME SEVERE COLD in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data 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 should consult their healthcare provider prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

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 with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the risk of liver damage.

Before initiating treatment, patients with known liver disease should consult their healthcare provider to assess the appropriateness of this product for their condition. Regular 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 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 appropriate 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 limits the assessment of potential risks associated with the compound in these areas.

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 help 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 initially apparent.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this medication if they have 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.

Patients should also be made aware that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or for two weeks following the cessation of such medications, which are often prescribed for depression, psychiatric conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should be advised to seek clarification from their healthcare provider.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Furthermore, patients should be advised to stop using the product and seek medical advice if their fever worsens or persists beyond three days, if they notice any redness or swelling, or if new symptoms arise. They should also be informed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than seven days, or if a cough recurs with a rash or persistent headache, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dosage while using this product. It is also essential for healthcare providers to encourage patients to consult with their doctor 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. Additionally, patients should be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, or emphysema. Lastly, patients taking the blood-thinning medication warfarin should be instructed to consult with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in pouches that should remain unopened until the time of use. It is essential to store the product at a controlled room temperature, specifically between 20°C and 25°C (68°F and 77°F). Additionally, the product must be protected from heat and moisture to ensure its integrity and effectiveness.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended frequency of every 4 hours while symptoms persist, and not to exceed 5 pods in a 24-hour period unless directed by a healthcare professional.

Clinicians should counsel patients on the importance of consulting a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent. Additionally, information regarding the potential for medicine abuse among teens can be found at 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.

View product document (PDF)