Aspirin

Description

11R-Winco-Aspirin is identified by the SPL code 34089-3. This formulation contains 325 mg of aspirin per unit. The product is packaged in bottles containing 100 tablets, each labeled accordingly.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, colds, muscle pain, menstrual pain, toothache, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Patients should drink a full glass of water with each dose 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 while symptoms persist. It is important not to exceed 12 tablets in a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a healthcare provider 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, 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 any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, current use of diuretics, asthma, inadequate fluid intake, or significant fluid loss due to vomiting or diarrhea. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, are on any other medications, or are under medical supervision for serious health conditions.

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 contact a healthcare professional if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other reasons to stop use include worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, the presence of redness or swelling in the affected area, the emergence of new symptoms, or the occurrence of ringing in the ears or hearing loss.

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 illness 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 doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Aspirin, the active ingredient in this product, may also provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing).

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing 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 while using this product, or exceed the recommended dosage or duration of use.

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. Other reasons to discontinue use and consult a doctor include worsening pain lasting more than 10 days, a fever that worsens or lasts more than three days, the presence of redness or swelling in the painful area, the emergence of any new symptoms, or experiencing 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. It is also advisable to seek medical advice if they are taking diuretics, have asthma, have not been adequately hydrating, or have lost significant fluid due to vomiting or diarrhea.

Furthermore, patients should ask a doctor or pharmacist before use if they are taking prescription medications for diabetes, gout, or arthritis, are on any other medications, or are under a doctor’s care for any serious condition.

Drug Interactions

Aspirin has the potential to interact with several classes of medications, leading to significant clinical effects.

Anticoagulants and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin may increase the risk of severe gastrointestinal bleeding when used concurrently with anticoagulants or other NSAIDs, such as ibuprofen or naproxen. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments or alternative therapies as necessary.

Diuretics Caution is warranted when aspirin is administered alongside diuretics. The combination may lead to altered renal function or electrolyte imbalances. Regular monitoring of renal function and electrolytes is recommended to mitigate potential risks.

Diabetes, Gout, and Arthritis Medications Patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare provider prior to initiating aspirin therapy. This is essential to ensure safe and effective use, as interactions may affect the management of these conditions.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin (aspirin tablet 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, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and over are directed to take 1 to 2 tablets every 4 hours while symptoms persist, with a maximum of 12 tablets in 24 hours unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised prior to use.

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, particularly gastrointestinal bleeding, underscores the importance of individualized assessment and management in this population.

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 physician.

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 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 the use of this medication in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable for patients taking diuretics to seek medical advice before initiating treatment. Additionally, patients under the care of a physician for any serious condition should discuss their renal function status with their doctor or pharmacist prior to use.

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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, and Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Additionally, asthma exacerbation, tinnitus, and hearing loss have been reported.

There have been reports of gastrointestinal ulcers and perforations, which can occur unexpectedly and may be fatal. Severe allergic reactions have also been documented, including hives, facial swelling, and shock. Furthermore, an increased risk of bleeding has been noted, particularly in patients who are taking anticoagulants or have a history of bleeding disorders.

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 history of allergic reactions to Aspirin or any other pain reliever or fever reducer. It is essential to counsel patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, patients should be advised to seek medical attention if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, if any new symptoms appear, or if they experience ringing in the ears or a loss of hearing.

Healthcare providers should encourage patients 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. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics, should also seek medical advice prior to use. Furthermore, patients with asthma or those who have not been drinking fluids, or who have lost a significant amount of fluid due to vomiting or diarrhea, should be advised to consult a healthcare professional.

Lastly, patients should be encouraged to ask 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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)