Bufferin Arthritis

Description

Buffered Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each coated tablet contains 325 mg of the active ingredient. The product is supplied in a package containing 60 coated tablets. This formulation is specifically designed for households without young children.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 tablets with a full glass of water. This dosage may be repeated every 4 hours as needed while symptoms persist. It is imperative not to exceed a total of 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless directed by a doctor.

Contraindications

Use of this product is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. This precaution is necessary to avoid potential complications associated with these conditions.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. The use of this product in these populations is contraindicated due to the risk of Reye's syndrome, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome.

Aspirin, a component of this product, has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, shock, and asthma (wheezing). Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The risk is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor before using this product if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients with a history of stomach problems, such as heartburn, asthma, or those taking diuretics should seek medical advice prior to use. It is also recommended that patients taking prescription medications for gout, diabetes, or arthritis consult with a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should be instructed to discontinue use and contact their doctor if they experience any signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical advice if an allergic reaction occurs, if symptoms do not improve, if they experience ringing in the ears or loss of hearing, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious condition requiring prompt medical evaluation.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. 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.

Aspirin may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients should discontinue use and seek medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop use and consult a doctor.

Additional adverse reactions that may warrant medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, the emergence of new symptoms, or the presence of redness or swelling.

Patients are advised to consult a doctor before using this product if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, a history of stomach problems such as heartburn, or asthma. It is also recommended that patients taking diuretics or prescription medications for gout, diabetes, or arthritis consult a doctor or pharmacist prior to use.

Patients should not use this product if they are allergic to aspirin or any other pain reliever or fever reducer.

Drug Interactions

Taking this product concurrently with other medications that contain either prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, may elevate the risk of gastrointestinal bleeding.

The risk of severe stomach bleeding is further increased in patients who are also using anticoagulants or steroid medications. It is advisable for healthcare providers to monitor patients closely for signs of gastrointestinal complications when these drugs are used in combination.

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

Packaging & NDC

Below are the non-prescription pack sizes of Bufferin Arthritis (aspirin). 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. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 2 tablets with a full glass of water, repeating every 4 hours as needed while symptoms persist, without exceeding 12 tablets in a 24-hour period unless directed by a physician. For children under 12 years of age, use is not recommended unless specifically directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing this medication to geriatric patients.

It is essential for healthcare providers to consult with elderly patients regarding their medical history, especially if they have a history of stomach problems, such as heartburn. Such consultations are crucial to ensure the safe use of the medication and to mitigate potential adverse effects associated with gastrointestinal complications.

Healthcare providers should remain vigilant in monitoring elderly patients for any signs of gastrointestinal distress or bleeding, and dose adjustments may be warranted based on individual patient assessments and risk factors.

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 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 before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy, 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate steps to take in the event of an overdose, ensuring that patients receive timely and effective care.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, and exacerbation of asthma. Additionally, cases of Reye's syndrome have been noted in children and teenagers recovering from chickenpox or flu-like symptoms. Other serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been reported. Instances of liver damage and renal impairment have been documented, as well as cardiovascular events, including myocardial infarction and stroke, associated with the long-term use of NSAIDs. It is important to note that these adverse reactions may not be fully represented in clinical trial data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. Providers should counsel patients to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, patients should seek medical advice if they experience an allergic reaction, if their symptoms do not improve, if they notice ringing in the ears or loss of hearing, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is present, as these could indicate a serious condition.

Patients should be made aware that if they experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor, as these symptoms could be early signs of Reye's syndrome, a rare but serious illness.

Healthcare providers should also recommend that patients consult a doctor before using this product if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with a history of stomach problems, such as heartburn, or those with asthma should also seek medical advice prior to use. Furthermore, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, 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 Bufferin Arthritis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)