Kortribion Pain Reliever

Description

KORTRIBION (NDC 69729-793-24) is an analgesic and pain reliever indicated for the temporary relief of mild pain and discomfort associated with various conditions, including joint pain, headache, muscle aches, back ache, inflammation, and arthritis. The product is available in a box containing 24 caplets. KORTRIBION is exclusively distributed by OPMX, located in Chula Vista, CA 91910, with a contact number of 619-600-5632.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, joint pain, back ache, inflammation, and arthritis.

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 tablets orally every 6 hours, ensuring that the total dosage does not exceed 6 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

It is imperative that the recommended dosage is not exceeded to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other drug containing acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. Healthcare professionals should advise patients to consult a doctor or pharmacist before combining this product with any other medications to ensure safety.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 caplets within a 24-hour period, using it concurrently with other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product. Healthcare professionals should counsel patients on these risks to ensure safe usage.

Caffeine is also present in the recommended dose of this product, approximately equivalent to that found in a standard cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General precautions should be observed. Patients with liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product to avoid potential interactions.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) 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 discontinue use and consult a healthcare professional if any new symptoms arise, if existing symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists for more than 10 days, or if fever worsens or lasts longer than 3 days. These guidelines are critical for ensuring patient safety and effective management of their condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Patients with liver disease should consult a healthcare professional before using this product.

Caffeine-related adverse reactions may arise from the concurrent use of caffeine-containing medications, foods, or beverages. These reactions can include nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to avoid using this product with any other drug containing acetaminophen, whether prescription or nonprescription. It is recommended that individuals consult a doctor or pharmacist if they are uncertain about the use of other medications alongside this product.

Patients taking the blood-thinning medication warfarin should seek guidance from a healthcare professional prior to using this product.

Patients should discontinue use and consult a doctor if any new symptoms arise, if symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists for more than 10 days, or if fever worsens or lasts for more than 3 days.

For pregnant or breastfeeding individuals, it is essential to consult a health professional before use.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this product. The combination may necessitate careful monitoring of coagulation parameters to avoid potential alterations in anticoagulant efficacy.

Additionally, it is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects, including nervousness, irritability, insomnia, and, in some cases, tachycardia. Monitoring for these symptoms is recommended to ensure patient safety and comfort.

Packaging & NDC

Below are the non-prescription pack sizes of Kortribion Pain Reliever (acetaminophen, caffeine). 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 2 tablets every 6 hours, with a maximum of 6 tablets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 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 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 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, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with acetaminophen use in the context of their liver function. Monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, emphasizing the importance of prompt medical attention 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 containing acetaminophen, whether prescription or nonprescription. It is essential for patients to consult with a doctor or pharmacist before using this medication alongside other drugs if they are uncertain.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any new symptoms arise. Additionally, patients should be advised to stop using the medication and seek medical advice if their symptoms do not improve or if they worsen. It is also important to inform patients to stop use and contact a doctor if the area experiencing pain becomes red or swollen, if the pain intensifies or persists for more than 10 days, or if a fever worsens or lasts longer than 3 days.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its integrity and efficacy.

It is essential to ensure that the safety seal under the cap is intact; the product should not be used if the tamper-evident seal is broken or missing. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum of 6 tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)