Adwe Feverx Acetaminophen Caplets, 500 mg

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the relief of minor aches and pains, as well as for the reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 1 to 2 caplets every 4 to 6 hours as needed. It is imperative that they do not exceed 6 caplets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor before administration.

Healthcare professionals should ensure that patients are aware of the importance of adhering to the prescribed dosage and not exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks for liver damage. The maximum recommended daily dosage is 6 caplets within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 8 caplets (4,000 mg of acetaminophen) in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Healthcare professionals should be aware of the potential for severe allergic reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be taken prior to use. Patients with a history of liver disease should consult a physician before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

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

Patients should be advised to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than 10 days, fever that worsens or persists for 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 who exceed the recommended dosage of acetaminophen, specifically if they take more than 8 caplets (4,000 mg) within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients should also be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose.

Packaging & NDC

Below are the non-prescription pack sizes of Adwe Feverx Acetaminophen Caplets, 500 mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1-2 caplets every 4-6 hours as needed, with a maximum of 6 caplets in a 24-hour period unless otherwise directed by a physician.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of liver disease. The potential for altered pharmacokinetics in this population necessitates careful consideration and monitoring.

Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin must seek advice from a healthcare professional or pharmacist before initiating treatment. The interaction between this medication and warfarin could necessitate dose adjustments or increased monitoring to ensure patient safety.

It is crucial for elderly patients to be aware that prompt medical attention is essential, even in the absence of noticeable signs or symptoms. This vigilance is particularly important for this demographic, as they may be at increased risk for adverse effects.

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum recommended daily dose is 6 caplets within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed the following limits:

• More than 8 caplets (4,000 mg of acetaminophen) in 24 hours.

• Concurrent use with other medications containing acetaminophen.

• Consumption of 3 or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this product based on their liver function. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In the event of overdosage, it is critical to recognize the potential for severe liver damage associated with excessive intake of this product. The maximum recommended daily dose is 6 caplets within a 24-hour period.

Risk Factors for Severe Liver Damage Severe liver damage may occur under the following circumstances:

• Ingestion of more than 8 caplets (equivalent to 4,000 mg of acetaminophen) within a 24-hour timeframe.

• Concurrent use of other medications that contain acetaminophen.

• Consumption of three or more alcoholic beverages daily while using this product.

Recommended Actions Healthcare professionals should be vigilant in assessing patients who may have exceeded the recommended dosage or who present with symptoms indicative of liver impairment. Immediate medical evaluation is advised for any patient suspected of an acetaminophen overdose.

Management Procedures Management of acetaminophen overdosage typically involves the administration of N-acetylcysteine (NAC) as an antidote, which is most effective when given within 8 hours of ingestion. Continuous monitoring of liver function tests and supportive care may be necessary, depending on the severity of the overdose and the patient's clinical status.

Prompt recognition and intervention are essential to mitigate the risk of serious complications associated with acetaminophen overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial 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 apparent.

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 about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, if a patient's fever intensifies or lasts longer than 3 days, they should stop using the medication and seek medical advice. Patients should also be advised to stop use and contact a doctor if they experience new symptoms or notice any redness or swelling, as these may indicate a serious condition.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° C to 25° C (68° F to 77° F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Adwe Feverx Acetaminophen Caplets, 500 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)