Agrifen

Description

AGRIFEN is a combination medication containing Acetaminophen 250 mg, Aspirin 250 mg (NSAID), and Caffeine 65 mg. It is indicated for the relief of inflammation and pain associated with fever, headaches, and toothaches. The product is available in the form of 12 caplets. The National Drug Code (NDC) for AGRIFEN is 69729-159-12.

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 and menstrual cramps.

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

Dosage and Administration

Healthcare professionals should advise patients to 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 that each dose is accompanied by a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is recommended that a healthcare provider be consulted prior to use to determine the appropriate dosage and administration.

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 severe liver damage may occur if the following conditions are met: exceeding 8 tablets within a 24-hour period (the maximum daily dosage), concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event 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 dosage or duration of use.

The recommended dosage 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.

Healthcare professionals should advise patients to 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. Patients with asthma or those taking diuretics should also seek medical advice before use. Furthermore, it is recommended that patients consult a doctor or pharmacist if they are 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 the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients 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. Additionally, any occurrence of an allergic reaction warrants immediate medical attention. Patients should also seek medical help if new symptoms arise, if they experience ringing in the ears or hearing loss, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, or if the affected area becomes red or swollen.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious Adverse Reactions Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

A severe allergic reaction to aspirin may manifest as hives, shock, facial swelling, or asthma (wheezing). Patients should seek immediate medical attention if any of these symptoms occur.

This product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 8 tablets within 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, the presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid drugs, or are consuming three or more alcoholic drinks daily. Patients should be vigilant for signs of stomach bleeding, which include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

Common Adverse Reactions Patients may also experience less severe but common reactions. The recommended dose of this product 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, patients are advised to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients should discontinue use and consult a doctor if they experience any new symptoms, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than three days, or if the painful area becomes red or swollen.

Precautions Before using this product, patients should consult a doctor if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also advisable to seek medical advice if they are taking diuretics or any prescription drugs for diabetes, gout, or arthritis.

Patients should not use this product if they have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer, or if they are taking any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience increased risks of adverse effects when co-administered with this drug. It is advisable to monitor for signs of bleeding or other complications and consider dosage adjustments as necessary.

Concomitant use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may heighten the risk of gastrointestinal irritation or bleeding. Close monitoring for gastrointestinal symptoms is recommended, and dosage adjustments may be warranted based on clinical judgment.

Additionally, patients on prescription medications for diabetes, gout, or arthritis should be closely monitored for potential interactions that could affect therapeutic outcomes. Adjustments to the dosage of these medications may be necessary to maintain optimal control of the underlying conditions.

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

Packaging & NDC

Below are the non-prescription pack sizes of Agrifen (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. The recommended dosage for adults and children aged 12 years and older 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. This risk is further heightened in individuals with a history of stomach problems, including but not limited to heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Additionally, caution is advised when considering the use of this product in geriatric patients due to the potential for increased side effects and complications. It is essential for healthcare providers to assess the overall health status of elderly patients and to monitor them closely for any adverse reactions.

Furthermore, it is recommended that patients with liver disease consult a healthcare professional prior to using this product, as liver function may influence the safety and efficacy of treatment in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. The potential fetal impacts and associated risks necessitate careful consideration and professional guidance for women of childbearing potential.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. 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.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree 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 alcohol can exacerbate the potential for liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 timely recognition and management of overdose situations can significantly impact patient outcomes. Therefore, it is essential to remain vigilant and proactive in addressing potential overdose cases.

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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

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 the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer.

It is essential 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 for clarification.

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

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

Lastly, patients should be instructed to ask a doctor or pharmacist before use if they are currently 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 a tamper-evident seal. It is essential to inspect the safety seal under the cap; the product should not be used if the seal is broken or missing.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F). However, excursions are permitted within a range of 15-30°C (59-86°F). Proper storage is crucial to ensure the integrity and efficacy of the product.

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 they are 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, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)