Aspirin 81mg Enteric Coated

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) with a dosage strength of 81 mg. It is commonly used for its analgesic, antipyretic, and anti-inflammatory properties. Aspirin is characterized by its white crystalline powder appearance and is soluble in organic solvents. The chemical formula for Aspirin is C9H8O4, and its molecular weight is 180.16 g/mol.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to inquire about additional uses for this product based on individual patient needs. There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

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

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 physician, 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, 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 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 or those with asthma should seek medical advice before use. It is also recommended that patients inform their healthcare provider or pharmacist if they are on prescription medications for anticoagulation, diabetes, gout, or arthritis.

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 discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing. Serious side effects can be reported to 1-888-952-0050.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Reye’s syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions to aspirin may occur, presenting as hives, facial swelling, asthma (wheezing), or 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, 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 healthcare provider 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. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Before using this product, patients should seek medical advice 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. Additionally, patients taking diuretics or those with asthma should consult a healthcare professional prior to use. It is also advisable for patients on prescription medications for anticoagulation, diabetes, gout, or arthritis to discuss their use of this product with a doctor or pharmacist.

Drug Interactions

Concurrent use of non-steroidal anti-inflammatory drugs (NSAIDs), including prescription and non-prescription agents such as aspirin, ibuprofen, and naproxen, may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these medications together and consider monitoring for signs of gastrointestinal distress.

The concomitant administration of anticoagulants or steroid medications may also heighten the risk of stomach bleeding. It is advisable for patients to consult their healthcare provider if they are receiving treatment with any prescription drugs for anticoagulation, diabetes, gout, or arthritis to ensure appropriate management and monitoring.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81mg 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 chicken pox 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 immediately, 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, with a maximum of 48 tablets in a 24-hour period unless otherwise 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 this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

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 fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if specifically 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 doctor, 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 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications 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

Serious side effects have been reported voluntarily or identified through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number, 1-888-952-0050.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Healthcare professionals should ensure that the product is not used if the safety seal is broken or missing, as this may indicate potential tampering or contamination.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is particularly critical to avoid 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.

Drug Information (PDF)

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

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