Aspirin 81 mg Enteric Coated

Description

Aspirin 81 mg Enteric Coated (EC) tablets are nonsteroidal anti-inflammatory drugs (NSAIDs) indicated for pain relief. Each tablet contains 81 mg of Aspirin USP. The product is specifically formulated for adult low strength use and is packaged in a container holding 1000 tablets. This package is intended for households without young children. The National Drug Code (NDC) for this product is 69618-046-10.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Due to its delayed action, it is not suitable for the fast relief of headaches or other symptoms requiring immediate alleviation. Healthcare professionals are encouraged to consult with patients regarding additional uses for enteric-coated 81 mg Aspirin.

There are no teratogenic or nonteratogenic effects associated with this product.

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 doctor 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 Reye's syndrome, a rare but potentially serious condition.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: signs of an allergic reaction, which necessitate immediate medical assistance; symptoms indicative of stomach bleeding, including feeling faint, the presence of bloody or black stools, vomiting blood, persistent stomach pain, worsening pain lasting more than 10 days, redness or swelling, the emergence of new symptoms, or experiencing ringing in the ears or loss of hearing. These symptoms may signify a serious underlying condition that requires prompt evaluation.

In the event of an overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately. Monitoring for these adverse effects is essential to ensure patient safety and effective management of any potential complications.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this product. Notably, 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. It is crucial that these individuals do not use this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms may indicate the onset of Reye's syndrome.

In addition to the serious risks, patients should discontinue use and seek medical attention if they experience any signs of an allergic reaction. Furthermore, the following symptoms may indicate stomach bleeding, which is a serious condition requiring prompt medical evaluation: feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Patients should also be vigilant for worsening pain, 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. These symptoms warrant immediate medical consultation to rule out serious underlying conditions.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question.

Additionally, the concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, is associated with an increased likelihood of severe stomach bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating treatment if they are currently using any NSAIDs.

Patients taking prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before using this drug. Furthermore, it is recommended that individuals on any other prescription or nonprescription medications consult with a doctor or pharmacist to ensure safe use.

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

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 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, as these may be early signs of Reye's syndrome.

For patients 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 of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in geriatric patients, especially when initiating treatment or adjusting dosages. Healthcare providers should consider the overall health status and concurrent medications of elderly patients to ensure safe and effective use of therapies.

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 concerning, as it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial 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 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 in lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of overdosage cases. It is critical to provide comprehensive care tailored to the patient's needs, including potential interventions based on the clinical presentation.

In summary, due to the lack of specific overdosage information, a cautious and supportive approach is recommended, with an emphasis on monitoring and individualized patient care.

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 associated with the use of the product. Reports have included allergic reactions, such as hives, facial swelling, shock, and asthma (wheezing). Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, users of other nonsteroidal anti-inflammatory drugs (NSAIDs), and those consuming three or more alcoholic drinks daily or exceeding the recommended dosage.

Patients are advised to seek immediate medical attention if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, including feeling faint, the presence of bloody or black stools, vomiting blood, or persistent stomach pain.

Patient Counseling

Healthcare providers should advise patients to keep the 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 the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, which may require immediate medical attention. Additionally, patients should be made aware of the signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if pain worsens or lasts more than 10 days. They should also report any redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these could indicate a serious condition.

Patients should be encouraged to consult a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to discuss any existing conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics, asthma, or if they have not been adequately hydrating or have lost significant fluids due to vomiting or diarrhea.

Furthermore, patients should be advised to seek guidance from a doctor or pharmacist before using the medication if they are taking prescription drugs for diabetes, gout, or arthritis, any other medications, or if they are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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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