Bufferin Regular Strength Pain Relief

Description

BUFFERIN® is a buffered aspirin formulation classified as a nonsteroidal anti-inflammatory drug (NSAID). It serves as a pain reliever and fever reducer. Each coated tablet contains 325 mg of buffered aspirin, and the product is available in a package containing 30 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, toothache, backache, muscular aches, minor pain of arthritis, the common cold, 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

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 hours. The total daily dosage should not exceed 12 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

Warnings and Precautions

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

Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event is increased in individuals who have a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals aged 60 years or older, those consuming three or more alcoholic beverages daily while using this product, and those taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen. Additionally, exceeding the recommended dosage or duration of use heightens this risk.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, asthma, previous stomach issues such as heartburn, current use of diuretics, or existing medical conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a physician if they experience any signs of an allergic reaction, such as hives or difficulty breathing. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, passing bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other concerning symptoms warranting medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, visible redness or swelling, or the emergence of new symptoms, as these may signify a serious underlying condition.

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 illness 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, an active ingredient in this product, may cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should stop using the product and seek medical attention promptly.

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 with a history of stomach ulcers or bleeding problems, those taking blood thinners or steroid medications, individuals aged 60 or older, those consuming three or more alcoholic drinks daily while using the product, and patients taking other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen. Additionally, taking more of the product or using it for a longer duration than directed may elevate the risk of stomach bleeding.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other symptoms warranting 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, presence of redness or swelling, or the emergence of new symptoms. These could indicate a serious condition requiring immediate medical attention.

Drug Interactions

Aspirin is associated with several significant drug interactions that warrant careful consideration.

Allergic Reactions Aspirin may induce severe allergic reactions in some individuals. Symptoms can include hives, shock, facial swelling, and asthma-like wheezing. Patients with a history of allergies to aspirin or related compounds should avoid its use and consult a healthcare professional.

Increased Risk of Gastrointestinal Bleeding The concomitant use of aspirin with anticoagulants or steroid medications significantly elevates the risk of severe gastrointestinal bleeding. It is advisable for healthcare providers to monitor patients closely for signs of bleeding and to consider dosage adjustments or alternative therapies as necessary.

Drug Interactions with Specific Conditions Patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare provider or pharmacist prior to initiating aspirin therapy. This precaution is essential to ensure safe and effective use, as interactions may alter the efficacy of these treatments or exacerbate underlying conditions.

Packaging & NDC

Below are the non-prescription pack sizes of Bufferin Regular Strength Pain Relief (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. If any changes in behavior accompanied by nausea and vomiting occur during use, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, the product should not be used unless directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Close monitoring of gastrointestinal symptoms is recommended for geriatric patients, and dosage adjustments may be necessary based on individual patient assessments and overall health status. Providers should consider the potential for increased sensitivity to medications and the likelihood of comorbid conditions that may influence treatment outcomes in elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child 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 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 its use in lactating individuals.

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 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 and effective 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 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition thoroughly and implement appropriate interventions based on clinical guidelines and the specific circumstances of the overdose.

In summary, immediate medical attention is essential in cases of overdose, and healthcare professionals should be prepared to provide comprehensive care and support to affected individuals.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, shock, facial swelling, and asthma (wheezing). Additionally, cases of stomach bleeding have been noted, particularly in patients with a history of stomach ulcers or bleeding problems, those taking blood thinners or steroids, individuals aged 60 or older, and those consuming three or more alcoholic drinks daily while using this product.

Furthermore, reports of serious adverse events have been received, including instances of Reye's syndrome in children and teenagers who have or are recovering from chickenpox or flu-like symptoms.

Patient Counseling

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

Patients must be informed not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer. Additionally, they should not use it if they have previously experienced an allergic reaction to this product or any of its ingredients. If an allergic reaction occurs, patients should stop using the medication and seek medical assistance right away.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Patients should also be advised to stop use and seek medical attention if they notice ringing in the ears or a loss of hearing, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

It is important for patients to consult a doctor before using this medication if they have a history of stomach bleeding, asthma, or stomach problems such as heartburn. Patients should also be advised to seek medical advice if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should be encouraged to speak with a doctor or pharmacist before use if they are currently taking a prescription drug for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. 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 inventory management and product safety.

Additional Clinical Information

The medication is administered orally. 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 explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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