Excinol Extra

Description

Excinol Extra is presented in a dosage form of 500 mg per capsule. The effective time for this formulation is noted as September 16, 2020. The product is associated with an image file, described as "image description," and is categorized under the media type image/jpeg. A reference value for the product is provided as Excinol Extra 500mg 30 Cap_Box.jpg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, backache, minor pain of arthritis, toothache, menstrual cramps, and muscular aches. Additionally, it is indicated for the temporary reduction of fever and for the relief of symptoms associated with the common cold.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 caplets every 4 to 6 hours as needed. The total daily dosage must not exceed 8 caplets within a 24-hour period to avoid potential adverse effects.

This product is contraindicated in children under 12 years of age, as its use in this population may lead to an overdose, which can result in serious liver damage.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a history of allergic reactions to acetaminophen or any of the inactive ingredients contained in this formulation.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the risk of liver injury increases if they 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 beverages daily while using 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 their healthcare provider or pharmacist before using this product, as potential interactions may occur.

Patients are instructed to discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires medical evaluation.

No specific instructions for obtaining emergency medical help are provided; however, healthcare professionals should remain vigilant for signs of severe adverse reactions and advise patients accordingly.

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 they experience worsening pain that lasts more than 10 days, a fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of 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. This interaction is significant due to the potential for altered anticoagulant effects, which may necessitate dosage adjustments or increased monitoring of coagulation parameters to ensure patient safety.

Packaging & NDC

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

Pediatric Use

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

Geriatric Use

There is no specific information regarding the use of Excinol Extra (acetaminophen) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and increased sensitivity to medications. Monitoring for efficacy and potential adverse effects 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 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 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 following limits:

• More than 4,000 mg of acetaminophen in a 24-hour period.

• Concurrent use with other medications that contain acetaminophen.

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

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the aforementioned risk factors. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy of treatment.

Overdosage

In cases of acetaminophen overdosage, significant health risks are associated with excessive intake.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient 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 toxicity.

Additionally, the consumption of three or more alcoholic beverages daily while using acetaminophen significantly increases the likelihood of severe liver damage.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is essential. Healthcare providers should assess the patient's liver function and consider the administration of N-acetylcysteine (NAC) as an antidote, particularly if the overdose is identified within a critical time frame. Continuous monitoring of liver enzymes and supportive care may also be necessary to manage the patient's condition effectively.

Prompt recognition and intervention are crucial to mitigate the potential for serious hepatic injury in cases of acetaminophen overdosage.

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

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 whether a medication contains acetaminophen, 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 present 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, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult their doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should also be advised to speak with their doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a controlled room temperature of 25°C (77°F). For optimal integrity, the product should be kept in its original container. Additionally, healthcare professionals should refer to the end panel of the packaging for the lot number and expiration date to ensure proper tracking and usage.

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 further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)