Fairfield Health Products Extra Strength

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing.

Each dose should be taken with a full glass of water to ensure proper administration and absorption. It is important to adhere strictly to the recommended dosage and not exceed the directed amount.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, regardless of the presence of signs or symptoms.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately.

Allergy Alerts This product may cause severe skin reactions due to acetaminophen, which can manifest as skin reddening, blisters, or rash. Additionally, aspirin may trigger a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Patients with a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer should not use this product.

Liver and Stomach Warnings The presence of acetaminophen in this product necessitates caution, as severe liver damage may occur if the maximum daily dosage of 8 caplets is exceeded, if it is taken concurrently with other acetaminophen-containing medications, or if consumed with three or more alcoholic drinks daily. Furthermore, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. Patients should avoid exceeding the recommended dosage or duration of use.

Caffeine Considerations The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages to prevent symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Pre-Use Consultation Patients should consult a healthcare professional before using this product if they have liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, individuals taking prescription medications for diabetes, gout, or arthritis, or those under a doctor’s care for any serious condition, should seek advice prior to use.

Discontinuation of Use Patients must stop using this product and seek medical attention if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms.

Pregnancy and Breastfeeding It is crucial for pregnant or breastfeeding individuals to consult a healthcare professional before using this product. Aspirin should be avoided during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Overdose Response In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions may occur due to the presence of acetaminophen and aspirin in this product. Symptoms of a severe skin reaction associated with acetaminophen may include skin reddening, blisters, and rash. Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should stop use and seek medical attention promptly.

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

Additionally, the presence of an NSAID in this formulation raises concerns regarding stomach bleeding. The risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroid medications, and those consuming three or more alcoholic drinks daily. Patients should also be cautious if they are taking other NSAIDs, whether prescription or nonprescription, and should not exceed the recommended duration or dosage.

Caffeine is also a component of this product, and patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients should discontinue use and consult a doctor if they experience any of the following: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, or any new symptoms. These could signify a serious condition requiring medical evaluation.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, is not advised due to the potential for increased risk of hepatotoxicity.

The concomitant use of this product with anticoagulants or steroid medications significantly elevates the risk of severe gastrointestinal bleeding. Caution is also warranted when this product is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, as this combination further increases the likelihood of gastrointestinal complications.

Additionally, it is recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption, which may lead to adverse effects.

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

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to assess the medical history of geriatric patients, especially in those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may necessitate closer monitoring or dosage adjustments to ensure safety and efficacy in this vulnerable group.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, 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 while breastfeeding.

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 exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Before initiating treatment, patients with a history of liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients 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 without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations, as early recognition and treatment can significantly impact patient outcomes.

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 postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours, not exceeding 8 caplets within a 24-hour period. For patients under 12 years of age, consultation with a healthcare provider is recommended before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

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