Theraflu

Description

THERAFLU® DAYTIME SEVERE COLD & COUGH is a combination product formulated to address multiple symptoms associated with colds and flu. The active ingredients include Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; and Phenylephrine HCl, a nasal decongestant. This product is indicated for the relief of nasal congestion, sore throat pain, cough, headache, body ache, and fever.

The formulation is presented in a berry flavor, enhanced with menthol and green tea flavors. It is packaged in a convenient format containing six packets. The product is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. For additional information, visit the official website at www.theraflu.com. The product is protected under copyright ©2017 GSK group of companies or its licensor.

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

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, while symptoms persist. It is imperative not to exceed five packets within a 24-hour period unless directed by a healthcare professional.

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

To prepare the medication, 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.

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

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 drinks daily while using this product.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or 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 any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm or chronic conditions such as 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 crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare professional 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 should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of acetaminophen, particularly if patients exceed 4,000 mg 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 more serious condition requiring prompt medical consultation.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, or sleeplessness; worsening fever lasting more than three days; redness or swelling; the emergence of new symptoms; and pain, cough, or nasal congestion that worsens or lasts more than seven days. A cough that recurs or occurs with a rash or headache that persists may also be indicative of a serious condition.

Patients with pre-existing conditions should consult a doctor before using this product if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, those experiencing a cough with excessive phlegm or a chronic cough associated with smoking, asthma, or emphysema should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a healthcare professional before using this product.

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, 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 used for at least two weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

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 necessary to ensure safe use and to avoid potential interactions that could increase the risk of 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 use this medication. For those aged 12 years and older, the recommended dosage is one packet. There are no established safety or efficacy profiles for children under 12, and 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.

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 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 should consult their healthcare provider prior to use, particularly if they experience difficulty urinating 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 that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concomitant use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult their healthcare provider prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is contraindicated, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions 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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. Reports of these adverse reactions have been received voluntarily and 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.

It is important to inform patients that this product is not intended 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), which are used for certain psychiatric or emotional conditions, or for 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 they experience nervousness, dizziness, or sleeplessness. Patients should also be advised to stop using the product and seek medical advice if their fever worsens or persists for more than three days, if they notice any redness or swelling, or if new symptoms arise. Furthermore, patients should be informed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a 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 a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F). Additionally, the product must be protected from heat and moisture to ensure its integrity and efficacy. Proper handling and storage conditions are vital for maintaining 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, without exceeding 5 packets in a 24-hour period unless directed by a healthcare professional. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before using the medication.

Additionally, information regarding the potential for medicine abuse, particularly among teens, can be found at www.StopMedicineAbuse.org. No further details are available regarding laboratory tests or postmarketing experiences.

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)