Theraflu Severe Cold Relief Daytime

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 lemon 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 4 hours as needed, with a maximum of 6 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. It is essential to stir the mixture briskly both before and after heating to ensure proper dissolution. Care should be taken to avoid overheating 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.

• 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen within a 24-hour period. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to 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 advised to consult a healthcare provider promptly.

Patients should be instructed to stop use and seek medical advice if any of the following occur: fever worsens or lasts longer than three days; redness or swelling is observed; new symptoms develop; pain, cough, or nasal congestion worsens or persists for more than seven days; or if a cough recurs or occurs 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 this product in conjunction with other medications containing acetaminophen, 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 a short duration should also prompt medical evaluation.

Before using this product, patients with liver disease, chronic cough associated with excessive phlegm, or chronic cough due to smoking, asthma, or emphysema should consult a healthcare professional. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist 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, whether prescription or nonprescription. Patients should also avoid using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If there is uncertainty regarding the presence of acetaminophen or an MAOI in other medications, patients should consult a healthcare professional.

Drug Interactions

Co-administration 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 for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be used for at least 2 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 use and to mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Theraflu Severe Cold Relief Daytime (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 younger than 12 years.

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.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 mothers.

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.

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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with acetaminophen use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with the use of acetaminophen: 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 initially 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 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.

Healthcare providers should also caution patients against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken 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 use and seek medical advice 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 immediate 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 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

Patients should be informed that the medication is administered orally and should be taken every 4 hours as needed for symptom relief, with a maximum of 6 packets in a 24-hour period unless otherwise directed by a clinician.

Clinicians are encouraged to educate patients about the potential for medicine abuse, particularly among teens, and can refer to resources such as www.StopMedicineAbuse.org for further information.

Drug Information (PDF)

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

View product document (PDF)