Artrifin 24 Caplets

Description

ARTRIFIN is presented in the form of 24 caplets, formulated as a pain reliever and fever reducer. It is indicated for the alleviation of various types of pain, including muscular aches, backache, and minor pain associated with arthritis. The product is designed to improve symptoms related to these conditions.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold, arthritis, muscular aches, sinusitis, toothache, and premenstrual or menstrual cramps.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 tablets every 6 hours, with a maximum limit of 8 tablets within a 24-hour period. It is essential to consume a full glass of water with each dose to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, shock, facial swelling, or asthma (wheezing).

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if the maximum daily dosage of 8 tablets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if the individual consumes three or more alcoholic drinks daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage.

The recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General precautions should be observed. Individuals should consult a physician prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those with asthma or who are taking diuretics should seek medical advice before use. It is also recommended to consult a doctor or pharmacist if the individual is taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Users should discontinue use and contact a physician if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. An allergic reaction, the appearance of new symptoms, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, or redness and swelling in the painful area also warrant immediate medical consultation.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include the risk of Reye's syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a healthcare professional immediately, as these may be early signs of this rare but serious condition.

An allergy alert is warranted, as aspirin may induce severe allergic reactions. Symptoms can include hives, shock, facial swelling, and asthma (wheezing). Patients with a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer should not use this product.

The product contains acetaminophen, which poses a liver warning. Severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within 24 hours, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this formulation raises a stomach bleeding warning. The risk of severe stomach bleeding is heightened in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid drugs, use other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage.

Patients should also be aware of a caffeine warning. The recommended dose contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Therefore, it is advisable to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients are advised to stop use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, any occurrence of an allergic reaction, new symptoms, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or fever lasting more than three days should prompt immediate medical attention.

Before using this product, patients should seek medical advice if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking a diuretic. It is also recommended to consult a healthcare professional if patients are taking prescription medications for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal bleeding is recommended in patients receiving these combinations.

Additionally, the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, either prescription or nonprescription, may elevate the risk of stomach bleeding. Caution should be exercised, and the use of multiple NSAIDs should be avoided.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Artrifin 24 Caplets (acetaminophen, aspirin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important to consult a healthcare professional if any changes in behavior accompanied by nausea and vomiting occur, as these may indicate the onset of Reye's syndrome.

For children under 12 years of age, it is advised to seek medical guidance before use. For those aged 12 years and older, the recommended dosage is 2 tablets every 6 hours, with a maximum of 8 tablets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems.

It is essential for geriatric patients to consult a healthcare provider prior to use if they have any underlying conditions such as liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Given the potential for adverse effects, careful monitoring and consideration of dosage adjustments may be necessary in this population to ensure safety and efficacy.

Pregnancy

Pregnant patients and women who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. 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 considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 tablets within a 24-hour period. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of liver injury.

Patients are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy during treatment.

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, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate occurrences of allergic reactions, which include hives, shock, facial swelling, and asthma (wheezing). Additionally, severe liver damage has been associated with the use of acetaminophen. There have been documented cases of severe stomach bleeding linked to the use of nonsteroidal anti-inflammatory drugs (NSAIDs), particularly in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems.

Symptoms of Reye's syndrome have been reported in children and teenagers recovering from chickenpox or flu-like symptoms. New symptoms, such as ringing in the ears or loss of hearing, have also been noted. Furthermore, cases of pain worsening or persisting for more than 10 days have been documented, along with instances of fever worsening or lasting more than 3 days. It is important to note that adverse reactions may occur if the product is used in conjunction with other medications containing acetaminophen or NSAIDs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients must be informed not to use this medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is crucial to instruct patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to stop using the medication and seek medical advice if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Additionally, patients should be made aware that they need to seek immediate medical help if they experience an allergic reaction, any new symptoms, ringing in the ears, or loss of hearing. They should also be advised to contact a healthcare professional if pain worsens or lasts for more than 10 days, if fever worsens or lasts for more than 3 days, or if the painful area becomes red or swollen.

Before using this medication, patients should be encouraged to consult a doctor if they have liver disease, if the warning for stomach bleeding applies to them, if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma or those taking a diuretic should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this medication if they are taking a prescription drug for diabetes, gout, or arthritis, or if they are taking any other medication or are under a doctor's care for any serious condition.

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 25°C (77°F), with permissible excursions between 15-30°C (59-86°F).

It is essential to ensure that the product is kept in its original container to maintain its integrity. Additionally, the product features a tamper-evident safety seal; therefore, it must not be used if the safety seal under the cap is broken or missing. Proper handling and storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets orally every 6 hours, with a maximum of 8 tablets in a 24-hour period. For children under 12 years, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients on the importance of consulting a health professional if pregnant or breastfeeding, particularly regarding the use of aspirin in the last trimester of pregnancy due to potential risks to the unborn child and complications during delivery. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, even in the absence of symptoms.

Drug Information (PDF)

This file contains official product information for Artrifin 24 Caplets, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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