Aspirin 81 mg Enteric Coated

Description

Aspirin is presented in a dosage form of 81 mg per tablet. Each bottle contains 120 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

Limitations of Use: This medication should not be used for more than 10 days without consulting a healthcare professional, as serious side effects may occur. For additional uses, patients are advised to seek guidance from their doctor.

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 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 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 physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

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 condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as 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 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 concurrently using anticoagulants or steroid medications, are taking 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, those with asthma, or individuals who have not been adequately hydrated or have experienced significant fluid loss due to vomiting or diarrhea should seek medical advice before use.

Patients should also be encouraged to discuss their current medications with a healthcare professional, particularly if they are taking prescription drugs for diabetes, gout, or arthritis, are under treatment for any serious medical condition, or are using any other medications.

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 healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, any redness or swelling in the painful area, the emergence of new symptoms, or symptoms such as ringing in the ears or hearing loss warrant immediate 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 illness that can 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 any changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients with a known allergy to aspirin should avoid this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened 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, or use other NSAIDs concurrently.

Patients are advised to stop using the product and seek medical attention 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 that worsens or lasts more than 10 days. Additional symptoms warranting medical consultation include redness or swelling in the painful area, the appearance of any new symptoms, or ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor 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. Those taking diuretics, with asthma, or who have not been adequately hydrated should also seek medical advice prior to use.

It is important for pregnant or breastfeeding patients 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.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience significant drug interactions. The concomitant use of these agents can increase the risk of bleeding or other adverse effects. It is advisable to monitor patients closely for signs of bleeding and to consider dosage adjustments as necessary based on clinical response.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may also lead to interactions. Co-administration of NSAIDs with anticoagulants or steroids can further elevate the risk of gastrointestinal bleeding and other complications. Clinicians should exercise caution and monitor patients for any adverse effects, adjusting dosages as appropriate.

Additionally, patients on prescription medications for diabetes, gout, or arthritis should be evaluated for potential interactions. The specific effects of these interactions were not detailed; however, careful monitoring and possible dosage adjustments may be warranted to ensure optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 mg Enteric Coated (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a doctor before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms 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, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For adolescents aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, not to exceed 48 tablets in a 24-hour period unless directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to advise geriatric patients to consult a physician prior to use if they have a history of stomach issues, such as heartburn, or if they have pre-existing conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics should seek medical advice before initiating treatment.

Healthcare providers should closely monitor elderly patients for signs of stomach bleeding, which may include feeling faint, the presence of bloody or black stools, vomiting blood, or persistent stomach pain. If any of these symptoms occur, patients should be instructed to discontinue use and consult a healthcare professional immediately.

Furthermore, if pain worsens or persists for more than 10 days, or if any new symptoms arise, patients should seek medical attention. It is also important to monitor for auditory symptoms, such as ringing in the ears or loss of hearing, as these may indicate adverse effects related to the medication.

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 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 may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to avoid potential adverse effects and to optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy. Special caution should be exercised in patients with significant hepatic impairment, as they may be at increased risk for adverse effects.

Patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be closely monitored, as these factors may further complicate the management of their hepatic condition.

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 aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 pose risks to the unborn child or lead to complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer.

Patients must be instructed 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 stomach pain that does not improve. Additionally, they should be aware that if pain worsens or persists for more than 10 days, if redness or swelling occurs in the painful area, if any new symptoms arise, or if they experience ringing in the ears or a loss of hearing, they should seek medical advice.

Healthcare providers should also recommend that patients consult a doctor before using the medication if any of the following conditions apply: a history of stomach problems, such as heartburn; the presence of high blood pressure, heart disease, liver cirrhosis, or kidney disease; current use of a diuretic; a diagnosis of asthma; insufficient fluid intake; or significant fluid loss due to vomiting or diarrhea.

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 25°C (77°F). Temporary excursions are permissible within the range of 15-30°C (59-86°F).

Healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety. Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspirin 81 mg Enteric Coated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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