Excinol Extra (acetaminophen)

Description

Excinol Extra is presented in a dosage form of 1000 mg per unit. The effective time for this formulation is noted as September 16, 2020. An accompanying image is available, described as "image description," and is formatted as a JPEG file. The reference for this product is documented as "Excinol Extra1000mg 24 Cap Box.jpg."

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, backache, minor pain of arthritis, toothache, menstrual cramps, muscular aches, and discomfort related to the common cold. 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 aged 12 years and over are advised to take 1 caplet every 6 to 8 hours as needed. The total daily dosage must not exceed 4 caplets within a 24-hour period.

For children under 12 years of age, this product is contraindicated. The use of this adult formulation in this age group may result in an overdose, which poses a risk of liver damage. Therefore, it is imperative that this product not be administered to children under 12 years.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in individuals with a history of allergic reactions to acetaminophen or any of the inactive ingredients contained in this formulation.

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 of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

It is essential to exercise caution in specific patient populations. Patients with liver disease should be advised to consult a physician prior to using this product. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before use, as potential interactions may occur.

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

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen 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 are advised to discontinue use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms develop, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Additionally, patients with a history of liver disease should seek medical advice before using this product. It is also recommended that patients taking the blood-thinning medication warfarin consult their doctor or pharmacist prior to use to avoid potential interactions.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult their healthcare provider or pharmacist prior to initiating treatment with this drug. The interaction between this medication 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 Excinol Extra (acetaminophen) (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this adult product, as it may result in an overdose that exceeds the recommended dosage and could lead to liver damage. It is essential for healthcare professionals to be vigilant and provide quick medical attention to both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients do not require specific dosage adjustments when using this medication, as there are no safety concerns identified in the provided data. However, it is essential for healthcare providers to monitor geriatric patients closely, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population. Regular assessment of therapeutic outcomes and adverse effects is recommended to ensure optimal treatment and safety in elderly individuals.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the potential for adverse effects in this population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if an individual ingests more than 4,000 mg of acetaminophen within a 24-hour period. This risk is compounded when acetaminophen is taken concurrently with other medications that also contain acetaminophen, as this can lead to cumulative dosing that exceeds safe limits.

Additionally, the risk of severe liver damage is heightened in individuals who consume three or more alcoholic beverages daily while using acetaminophen. The interaction between alcohol and acetaminophen can exacerbate hepatotoxicity, leading to potentially life-threatening conditions.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's clinical status and consider the need for supportive care and potential interventions, such as the administration of N-acetylcysteine, which may mitigate liver damage if given promptly. Monitoring liver function tests and providing symptomatic treatment are also critical components of management in cases of acetaminophen overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported in the context of 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 product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to acetaminophen or any of the inactive ingredients contained in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, if new symptoms develop, or if they notice any redness or swelling, as these may indicate a serious condition.

Additionally, patients should be advised to consult with their healthcare provider before using this medication if they have liver disease. It is also important to recommend that patients speak with their doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. Healthcare professionals are advised to check the end panel of the packaging for the lot number and expiration date, which are essential for tracking and inventory management. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

The product is administered orally, with the recommended dosage for adults and children aged 12 years and older being one caplet every 6 to 8 hours, not exceeding four caplets within a 24-hour period. For children under 12 years, the product is not recommended, as it may lead to an overdose and potential liver damage.

Clinicians should advise patients to consult a healthcare professional if they are pregnant or breastfeeding prior to use. Additionally, patients with liver disease or those taking the anticoagulant warfarin should seek medical advice before using this product.

Drug Information (PDF)

This file contains official product information for Excinol Extra (acetaminophen), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)