Aspirin

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 fast relief of headaches or other symptoms requiring immediate alleviation.

Healthcare professionals are encouraged to inquire about additional uses for safety 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 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 of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be administered to patients who have previously experienced an allergic reaction to this product or any of its components.

Warnings and Precautions

Patients, particularly children and teenagers 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 illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms 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 problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be obtained, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients are advised to discontinue use and contact their doctor if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms warranting medical consultation include worsening pain lasting more than 10 days, fever persisting beyond 3 days, the presence of redness or swelling, ringing in the ears, loss of hearing, or the emergence of new symptoms, as these may signify a serious underlying condition.

Side Effects

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

Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients experience 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.

Aspirin may also provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

Additionally, 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), 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 persistent stomach pain. Other reasons to seek medical advice include worsening pain lasting more than 10 days, fever lasting more than 3 days, presence of redness or swelling, ringing in the ears, loss of hearing, or the emergence of new symptoms, as these could indicate a serious condition.

Before using this product, patients should consult a healthcare professional if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also advisable to seek guidance 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 certain classes of medications.

Anticoagulants and Antiplatelet Agents The concomitant use of aspirin with anticoagulant drugs may significantly increase the risk of bleeding. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments as necessary.

Corticosteroids Co-administration of aspirin with steroid medications may also elevate the risk of gastrointestinal bleeding. Clinicians should exercise caution and monitor for adverse effects in patients receiving both therapies.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The use of aspirin in conjunction with other NSAIDs, whether prescription or over-the-counter (e.g., ibuprofen, naproxen), can further increase the risk of severe stomach bleeding. It is recommended that healthcare providers assess the necessity of concurrent NSAID therapy and consider alternative pain management strategies.

Drug & Laboratory Test Interactions Patients taking prescription medications for gout, diabetes, or arthritis should consult with a healthcare professional prior to initiating aspirin therapy. This is to ensure appropriate management and monitoring of potential interactions that may affect treatment outcomes.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product without consulting a doctor. It is important to note that children and teenagers who have or are recovering from chickenpox or flu-like symptoms are at risk for Reye's syndrome and should avoid this product. 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, a rare but serious condition.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, a doctor's consultation is necessary to determine appropriate use and dosage.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is crucial for healthcare providers to assess the individual risk factors for stomach bleeding in geriatric patients prior to prescribing this medication.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of adverse effects, including high blood pressure, heart disease, liver cirrhosis, or kidney disease. Given the potential for increased susceptibility to complications in this population, careful monitoring and consideration of alternative therapies may be warranted.

In summary, geriatric patients should be evaluated thoroughly for risk factors associated with NSAID use, and appropriate precautions should be taken to mitigate the risk of serious gastrointestinal events.

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 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 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 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 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 the impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication due to compromised liver function. It is essential to assess the severity of liver impairment before initiating treatment.

In patients with liver cirrhosis, careful consideration should be given to the potential need for dosage adjustments. Monitoring of liver function tests is recommended to evaluate the patient's hepatic status throughout the treatment course.

Additionally, patients with a history of high blood pressure, heart disease, or kidney disease should be closely monitored, as these conditions may further complicate the management of therapy in the context of hepatic impairment. Regular assessment of relevant laboratory values is advised to ensure patient safety and therapeutic efficacy.

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, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide comprehensive care, which may include supportive measures and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is essential to address any complications that may arise during the management of an overdose.

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 non-teratogenic effects have been explicitly stated in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within a temperature range of 15º to 30ºC (59º to 86ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's integrity.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. It is particularly crucial to avoid the use of aspirin during the last trimester 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)