Pharbest Aspirin 325mg

Description

PHARBEST is a nonsteroidal anti-inflammatory drug (NSAID) formulated to provide temporary relief of minor arthritis pain. Each enteric-coated tablet contains 325 mg of aspirin, which is comparable to the active ingredient in Ecotrin®. The product is manufactured in the USA and is available in a bulk package containing 1000 tablets. The safety coating of the tablets is designed to minimize gastrointestinal irritation associated with aspirin use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor arthritis pain, headache, toothache, menstrual pain, muscle pain, and discomfort due to colds. It may also be used as recommended by a healthcare professional.

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 1 to 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, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Patients should discontinue use and seek medical attention if any signs of an allergic reaction occur. Additionally, the product should not be used if the patient experiences symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain.

The product is also contraindicated if pain worsens or persists for more than 10 days, if redness or swelling is observed, if new symptoms develop, or if there is ringing in the ears or loss of hearing.

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. If any 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 this rare but serious illness.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. 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 carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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 beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to use if any of the following conditions apply: 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, patients should be encouraged to discuss their use of prescription medications for gout, diabetes, or arthritis with their healthcare provider or pharmacist before starting this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any 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), worsening pain lasting more than 10 days, redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing. These symptoms may signify a serious underlying condition that requires 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, the active ingredient in this product, may cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should 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 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. Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additional adverse reactions may include worsening pain that lasts more than 10 days, the presence of redness or swelling, the appearance of new symptoms, and symptoms such as ringing in the ears or loss of hearing. Patients are advised to stop using the product and seek medical advice if any of these symptoms occur.

Before using this product, patients should consult a doctor if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics or prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulant medications or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Clinicians should exercise caution and consider monitoring patients for signs of gastrointestinal complications when these combinations are prescribed.

Additionally, it is advisable for patients to consult a healthcare professional prior to initiating aspirin therapy if they are currently taking prescription medications for conditions such as gout, diabetes, or arthritis. This consultation is essential to ensure safe and effective use of aspirin in conjunction with these treatments.

Packaging & NDC

Below are the non-prescription pack sizes of Pharbest Aspirin 325mg (aspirin). 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and over are directed to take 1 to 2 tablets every 4 hours, with a maximum of 12 tablets in 24 hours unless otherwise directed by a doctor. 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, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of gastrointestinal issues, such as heartburn, or comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Healthcare providers should consult with elderly patients regarding the stomach bleeding warning and assess their individual risk factors prior to initiating treatment. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to facilitate timely intervention if necessary.

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 prior to 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 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 while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 use of the medication. Adjustments to dosage or specific monitoring parameters may be necessary based on the severity of hepatic impairment. Therefore, healthcare providers should assess the patient's overall health status, including any comorbidities such as high blood pressure or heart disease, to determine the most suitable treatment approach.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance ingested. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, throat, or tongue. Patients should also be made aware of the symptoms indicative of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing, they should seek medical attention promptly, as these may signal a serious condition.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, those taking diuretics or who have asthma should discuss their conditions with a healthcare professional before using this medication.

Lastly, patients should be reminded to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis, as these may interact with the treatment.

Storage and Handling

The product is supplied in configurations that adhere to the National Drug Code (NDC) standards. It is essential to store the product in a controlled environment, maintaining a temperature range below 20-25°C (68-77°F). Care should be taken to avoid exposure to excess heat and moisture, as these conditions may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product's efficacy and safety.

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 Pharbest Aspirin 325mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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