Safety Coated Aspirin 325 mg Regular Strength

Description

PHARBEST is a regular strength pain reliever formulated with 325 mg of aspirin, an active ingredient comparable to that found in Ecotrin®. This nonsteroidal anti-inflammatory drug (NSAID) is designed for the temporary relief of minor arthritis pain. Each bottle contains 1000 enteric-coated tablets, which are safety coated to enhance gastrointestinal tolerance. PHARBEST is manufactured in the USA and is identified by the National Drug Code (NDC) 73057-357-11.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor arthritis pains, headaches, toothaches, menstrual pain, muscle pain, and 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 as needed. It is important 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, 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. Due to the potential for severe allergic responses, such patients should avoid this product.

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 Reye's syndrome, a rare but serious condition.

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 using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use. It is also recommended that patients on prescription medications for gout, diabetes, or arthritis consult with their doctor or pharmacist prior to using 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 discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, such as hives or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, or passing bloody or black stools. Additional reasons to stop use include persistent stomach pain, worsening pain lasting more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or experiencing ringing in the ears or loss of hearing, as these may signal a serious condition.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings 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. Patients should not use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin may also provoke severe allergic reactions in some patients, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is necessary if any signs of an allergic reaction occur.

Additionally, 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 this product, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and seek medical advice if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. Other concerning symptoms include persistent stomach pain, worsening pain lasting more than 10 days, redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing, as these may indicate a serious condition.

Before using this product, patients should consult a healthcare professional if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to seek medical advice if taking diuretics or if there is a history of asthma. Furthermore, patients should inform their doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of gastrointestinal distress.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may further increase the risk of severe stomach bleeding when taken concurrently. It is advisable to assess the necessity of NSAID therapy in patients already receiving anticoagulants or steroids and to monitor for any gastrointestinal complications.

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

Packaging & NDC

Below are the non-prescription pack sizes of Safety Coated Aspirin 325 mg Regular Strength (aspirin 325mg). 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. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For dosing instructions, it is advised that children under 12 years of age should consult a doctor before use.

Geriatric Use

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

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, and careful evaluation of the benefits versus risks should guide treatment decisions in elderly patients.

Pregnancy

The use of aspirin during pregnancy, particularly in the last trimester, is associated with potential risks to the unborn child and complications during delivery. Healthcare professionals should advise pregnant patients against the use of aspirin during this period unless specifically directed by a physician. The risks may include adverse fetal outcomes, and careful consideration should be given to the benefits and risks of aspirin therapy in pregnant patients. It is essential for women of childbearing potential to discuss any medication use with their healthcare provider to ensure the safety of both the mother and the fetus.

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 in lactating mothers.

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 use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring due to the potential impact of compromised liver function on the pharmacokinetics of the medication. Adjustments to dosage may be necessary based on the severity of liver impairment, and ongoing assessment of liver function is recommended 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 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 taken. 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, consume alcohol regularly, or exceed the recommended dosage.

Serious conditions associated with aspirin use have also been reported. These include signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain. Furthermore, new symptoms such as ringing in the ears or loss of hearing have been documented.

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, lips, or throat, and to seek medical help immediately. Patients should also be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, or having bloody or black stools. They should be advised to stop using the medication and contact a healthcare professional if they experience persistent stomach pain, worsening pain that lasts more than 10 days, redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these may indicate a serious condition.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as individuals taking diuretics or those with asthma, should seek medical advice prior to use.

Finally, patients taking prescription medications for gout, diabetes, or arthritis should be advised to consult their doctor or pharmacist before using this medication to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excess heat and moisture to maintain product integrity.

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

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