Aspirin 81mg

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Healthcare professionals are advised to consult with patients regarding additional potential uses for enteric coated 81 mg Aspirin.

Limitations of Use: 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 4 to 8 tablets every 4 hours. The total daily dosage should not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless specifically directed by a physician.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Patients should be informed to seek immediate medical attention if any signs of an allergic reaction occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk is heightened in individuals who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Monitoring and Consultation Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur:

• Signs of an allergic reaction

• Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain

• Worsening pain or pain that lasts longer than 10 days

• Ringing in the ears or loss of hearing

• Presence of redness or swelling

• Development of new symptoms

These symptoms may signify a serious underlying condition that requires medical evaluation.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. 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. 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.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should seek immediate medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to 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 blood thinners or steroid medications, consume three or more alcoholic drinks daily while using this product, or take other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen. Patients should be advised to stop use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients are also cautioned to seek medical advice if pain worsens or lasts longer than 10 days, if they experience ringing in the ears or loss of hearing, if redness or swelling occurs, or if new symptoms develop, as these may indicate a serious condition.

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. It is also advisable to seek medical advice 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 anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. The concomitant use of these medications should be approached with caution due to the increased risk of bleeding.

Patients who are prescribed medications for gout, diabetes, or arthritis are advised to consult their healthcare provider prior to initiating aspirin therapy. This is essential to ensure safe use and to evaluate the need for any dosage adjustments or enhanced monitoring based on individual treatment regimens.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a doctor. 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 healthcare professional.

Caution is advised for children and teenagers who have or are recovering from chicken pox or flu-like symptoms, as the use of this product in such cases may increase the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

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 pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully evaluate the necessity of aspirin in these patients, considering the potential fetal impacts and the timing of administration.

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 absence of detailed information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL).

Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from potential overdosage. In the absence of detailed guidance, it is recommended that standard supportive measures be employed in the event of suspected overdosage.

In cases where overdosage is suspected, it is essential to assess the patient's clinical status and provide symptomatic treatment as necessary. Consultation with a poison control center or a medical toxicologist may be beneficial for further management strategies.

Continued vigilance and appropriate clinical judgment are paramount in managing any potential overdosage scenarios.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 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 immediately or contact a Poison Control Center at 1-800-222-1222.

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, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to seek medical advice if their pain worsens or lasts longer than 10 days, if they experience ringing in the ears or a loss of hearing, if redness or swelling occurs, or if new symptoms develop, as these could indicate a serious condition.

Healthcare providers should encourage patients to consult with 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. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or who have asthma, should also be advised to seek medical guidance prior to use.

Furthermore, patients should be encouraged to ask a doctor or pharmacist before using the medication if they are currently taking prescription drugs for gout, diabetes, or arthritis to avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature of 20-25°C (68-77°F) to ensure its stability and efficacy.

After each use, it is crucial to close the cap tightly to maintain the integrity of the product and prevent contamination. Proper handling and storage conditions are vital for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)