Theraflu Severe Cold Relief Daytime Berry Burst

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 berry burst 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, including minor aches and pains, minor 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

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the appropriate dosage is one packet every four hours as needed, not to exceed five packets within a 24-hour period unless otherwise directed by a healthcare professional.

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

To prepare the dosage, 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 utilizing a microwave for preparation, the contents of one packet should be added to 8 ounces of cool water. The mixture must be stirred briskly before and after heating, ensuring that it is not overheated.

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 poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have a history of 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 consult a healthcare provider or pharmacist before using this product.

In cases of overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare professional 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 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 or cough worsens or persists for more than seven days. A cough that returns or occurs with a rash or headache lasting longer than usual 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 with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu Severe Cold Relief Daytime Berry Burst (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 those 12 years and older, the recommended dosage is one packet. 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 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 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 regarding 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 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. 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 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 per day while using this product is not recommended, as it may exacerbate the risk of liver damage.

Additionally, patients with a history of liver disease should consult their healthcare provider prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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

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 present.

It is important to inform patients that this medication should not be used in children under 12 years of age. Additionally, patients should be cautioned against using this product if they have a known allergy to acetaminophen or if they are currently taking any other medication that contains 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 medication should not be used in conjunction with any prescription monoamine oxidase inhibitors (MAOIs), which are used for treating depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks after discontinuing an MAOI. If patients are unsure whether their prescription includes an MAOI, they should be advised to consult a healthcare professional.

Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience a worsening fever that lasts more than 3 days, or if they notice any redness or swelling. Patients should also be advised to stop use and consult a doctor if new symptoms arise, if pain or cough worsens or persists for more than 7 days, or if a cough recurs with a rash or headache that lasts, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult their doctor before using this medication. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus), a chronic cough due to smoking, asthma, or emphysema, should also seek medical advice prior to use. Lastly, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It should be stored at a controlled room temperature ranging from 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

No additional information is available regarding laboratory tests, route, method, and frequency of administration, or postmarketing experience.

Clinicians are advised to educate patients about the potential for medicine abuse, particularly among teens, and can refer to www.StopMedicineAbuse.org for further information. It is essential for patients to read all warnings and directions on the carton before use and to retain the carton for future reference.

Drug Information (PDF)

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

View product document (PDF)