Adwe Feverx

Description

Adwe Feverx is an acetaminophen formulation available in extra strength tablets, each containing 500 mg of acetaminophen. The product is packaged in a bottle containing 100 tablets. It is indicated as a pain reliever and fever reducer. The formulation is kosher for Passover and is comparable to the active ingredient found in Extra Strength Tylenol®. The National Drug Code (NDC) for this product is 666576-200-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is also 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 over are advised to take 1 to 2 tablets every 4 to 6 hours as needed. It is important not to exceed a total of 6 tablets within a 24-hour period.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the acetaminophen content of a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg (equivalent to 8 tablets) within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients with a history of liver disease should be cautioned to consult a physician prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product, as potential interactions may occur.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact the Poison Control Centre immediately. Prompt medical attention is crucial for both adults and children, even if no immediate symptoms are apparent.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg (8 tablets) in a 24-hour period, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients with liver disease should consult a doctor prior to use.

Participants taking blood-thinning medications, such as warfarin, are advised to seek guidance from a healthcare professional or pharmacist before using this product.

Patients should discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

An overdose warning is also provided, indicating that taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Centre immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking blood-thinning medications, specifically warfarin, should consult with a healthcare professional prior to initiating treatment. The interaction between the drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1-2 tablets every 4-6 hours as needed, with a maximum of 6 tablets in a 24-hour period.

Healthcare professionals should be aware of the overdose warning, which emphasizes the importance of seeking quick medical attention for both adults and children, even in the absence of noticeable signs or symptoms. Additionally, it is crucial to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, or safety concerns pertinent to this population. Consequently, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual responses may vary. Monitoring for efficacy and safety is advised, given the lack of targeted data for this demographic.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 (8 tablets) in a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical attention is essential. This is particularly important for both adults and children, even in the absence of noticeable signs or symptoms of liver damage. Prompt intervention can significantly mitigate the risk of serious complications.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Recommended Actions Immediate medical assistance should be sought in cases of overdose. Healthcare providers are advised to contact the Poison Control Centre without delay. Quick intervention is crucial, as the risk of severe complications can escalate rapidly.

Symptoms and Management It is important to note that symptoms may not be immediately apparent. Therefore, even in the absence of noticeable signs, both adults and children require urgent medical evaluation. Healthcare professionals should be prepared to manage potential complications associated with liver damage and provide supportive care as necessary.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information, and there are no details available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be instructed to stop using the medication and seek medical advice if they experience any of the following: worsening pain or pain that lasts more than 10 days, worsening fever or fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

Additionally, it is important for healthcare providers to remind patients to consult a doctor before using this medication if they have a history of liver disease. Patients taking the blood-thinning medication warfarin should also be advised to speak with a doctor or pharmacist prior to using this medication to avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20ºC to 25ºC (68ºF to 77ºF) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the imprinted seal under the cap is missing or broken, as this may indicate compromised safety or quality. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Adwe Feverx, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)