Aspirin

Description

Low Dose Aspirin is formulated as an 81 mg enteric-coated round tablet, serving as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief. The tablet is yellow in color and features a safety coating to ensure integrity. It is designed to be tamper-evident; users should not utilize the product if the safety seal under the cap is broken or missing. For proper usage, the container should be closed tightly, and the cap should be opened by pushing down and turning. This product is not manufactured or distributed by Bayer HealthCare LLC, which holds the registered trademark for Bayer® Low Dose Aspirin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

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

Dosage and Administration

Patients should take each dose with a full glass of water to ensure proper hydration 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 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, a rare but serious illness. 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 may be early signs of Reye's syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Healthcare professionals should be vigilant for these symptoms 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 increases under certain conditions, including concurrent use of other NSAIDs (prescription or nonprescription), prolonged use beyond the recommended duration, a history of stomach ulcers or bleeding issues, consumption of three or more alcoholic drinks daily while using this product, concurrent use of blood thinners (anticoagulants) or steroid medications, and in individuals aged 60 years or older.

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 doctor or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Immediate medical attention is also warranted for any allergic reactions, the emergence of new symptoms, ringing in the ears or hearing loss, worsening pain lasting more than 10 days, or the presence of redness or swelling.

Side Effects

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

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. Patients should not use this product under these circumstances. If any changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help immediately.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who take other NSAIDs, exceed the recommended dosage or duration of use, have a history of stomach ulcers or bleeding problems, consume three or more alcoholic drinks daily while using the product, take anticoagulants or steroid medications, or are aged 60 or older.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Additionally, if new symptoms arise, if there is ringing in the ears or loss of hearing, if pain worsens or lasts more than 10 days, or if redness or swelling is present, medical advice should be sought.

Before using this product, patients should consult a doctor if any of the following apply: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It is also important to discuss the use of this product with a healthcare professional if the patient is taking prescription medications for gout, diabetes, or arthritis.

Pregnant or breastfeeding patients should seek advice from a health professional before using this product, particularly during the last three months of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription agents such as aspirin, ibuprofen, and naproxen, may elevate the risk of severe gastrointestinal bleeding. Caution is advised when these medications are used concurrently.

The use of anticoagulants or steroid medications in conjunction with this drug may also heighten the risk of severe stomach bleeding. It is recommended that healthcare professionals closely monitor patients who are prescribed these combinations.

Patients taking prescription medications for conditions such as gout, diabetes, or arthritis should seek guidance from a healthcare provider or pharmacist prior to initiating treatment with this drug to ensure safety and efficacy.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are directed to 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 of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this 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. Therefore, it is essential 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 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 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 a history of liver cirrhosis. It is essential for these patients to discuss their liver function status, as compromised liver function may influence the safety and efficacy of the treatment. Monitoring of liver function tests may be warranted to ensure appropriate management and to mitigate potential risks associated with the use of this medication in individuals with hepatic impairment.

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 can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.

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 medication. These include gastrointestinal bleeding, allergic reactions (including anaphylaxis), asthma exacerbation, renal impairment, hepatic impairment, skin reactions (such as rash and urticaria), tinnitus, and hearing loss.

Gastrointestinal bleeding has been reported, particularly in patients with a history of ulcers or those concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis cases have been documented in individuals with a known history of aspirin allergy. Asthma exacerbations have been observed in patients with a history of asthma, especially among those sensitive to aspirin.

Renal impairment has been noted, particularly in patients with pre-existing kidney conditions or those receiving other nephrotoxic medications. Hepatic impairment has been reported in patients with underlying liver disease or those taking other hepatotoxic drugs. Skin reactions, including rash and urticaria, have also been reported in the postmarketing setting. Additionally, tinnitus and hearing loss have been associated with the use of high doses of aspirin.

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.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing stomach pain that does not improve.

In the case of an allergic reaction, patients must stop using the product and seek medical help right away. They should also be informed to stop use and consult a doctor if new symptoms arise, if they experience ringing in the ears or loss of hearing, if pain worsens or persists for more than 10 days, or if there is any redness or swelling.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to seek medical guidance prior to use.

Patients with asthma or those taking a diuretic should also be encouraged to consult a doctor before using the product. Furthermore, it is important for patients to discuss with their doctor or pharmacist if they are taking any prescription medications for gout, diabetes, or arthritis prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. 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).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)