Theraflu Flu Relief Max Strength

Description

Theraflu Multi-Symptom Flu Relief is a daytime formula designed to alleviate various flu symptoms. Each packet contains acetaminophen, a pain reliever and fever reducer, and dextromethorphan HBr, a cough suppressant. The product is formulated to provide relief from fever, body aches, headaches, sore throat pain, and cough. It is presented in a hot liquid therapy format with a honey lemon flavor. The product is packaged in a box containing six individual packets.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu, including headache, minor aches and pains, cough due to minor throat and bronchial irritation, and minor sore throat pain. 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 12 years of age and older are advised to take one packet. For children under 12 years of age, the product should not be used.

The recommended administration is to take the medication every 6 hours while symptoms persist. Patients should not exceed 3 packets in a 24-hour period unless directed by a healthcare professional.

To prepare the medication, dissolve the contents of one packet in 8 ounces of hot water and sip the solution while it is still hot. It is important to consume the entire drink 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 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.

• Concurrently 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 a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should not use this product concurrently with other medications that contain acetaminophen, nor should they consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

Healthcare professionals should instruct patients to stop using the product and seek medical advice if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists beyond three days; redness or swelling develops; new symptoms arise; or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

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

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver damage and severe allergic reactions.

Severe liver damage may occur if patients 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.

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.

Common adverse reactions warranting medical advice include worsening pain or cough lasting more than seven days, fever worsening or lasting more than three days, presence of redness or swelling, occurrence of new symptoms, or a cough that returns or occurs with a rash or headache lasting longer than expected.

Patients with pre-existing conditions such as 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 also seek advice from a healthcare professional prior to use.

This product is contraindicated in children under 12 years of age, in individuals with a known allergy to acetaminophen, and in those currently taking any other medications containing acetaminophen. It should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or for two weeks following the cessation of such medications. If patients are uncertain whether their prescription includes an MAOI, they should consult a doctor or pharmacist before use.

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 or other serious adverse effects.

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 necessary to ensure safe and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu Flu Relief Max Strength (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 threshold. Healthcare professionals are advised to consider alternative treatments for pediatric patients in this age range.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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.

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 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 individuals 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 within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients who consume three or more alcoholic drinks daily should also refrain from using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients 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, 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

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

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 medication is not recommended for use 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 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 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. They should refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are unsure whether their prescription includes an MAOI, they should seek clarification from a healthcare professional.

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

Patients with liver disease should be advised to consult a doctor before using this medication. Furthermore, those experiencing a cough with excessive phlegm or a chronic cough, such as that associated with smoking, asthma, or emphysema, should also 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 a doctor or pharmacist.

Storage and Handling

The product is supplied in tamper-evident inner units. Healthcare professionals should ensure that the Theraflu packet is not used if the seal is torn or broken, as this indicates potential tampering.

Storage conditions require the product to be maintained at a controlled room temperature, specifically between 20 – 25°C (68 – 77°F). It is essential to adhere to these temperature ranges to ensure the integrity and efficacy of the product.

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 signs or symptoms. Parents are encouraged to learn about the risks of medicine abuse among teens through resources such as www.StopMedicineAbuse.org.

Drug Information (PDF)

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

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