Aspirin

Description

Kirkland Signature Low Dose Aspirin contains the active ingredient aspirin at a strength of 81 mg per tablet. This nonsteroidal anti-inflammatory drug (NSAID) is formulated as enteric-coated tablets, designed to minimize gastrointestinal irritation. The product is packaged in a size of 2 x 365 tablets.

Manufactured by LNK International, Inc., located at 60 Arkay Drive, Hauppauge, NY 11788, USA, this product is distributed for Costco Wholesale Corporation, P.O. Box 34535, Seattle, WA 98124-1535, USA. The National Drug Code (NDC) for this product is 63981-563-96.

The product features a tamper-evident safety seal, and it should not be used if the seal is broken or missing. It is comparable to Bayer® Low Dose Aspirin; however, it is not manufactured or distributed by Bayer AG, the owner of the registered trademark. For inquiries, contact 1-800-774-2678 or visit www.costco.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

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

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 used in patients who have a history of allergic reactions to this product or any of its components.

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 illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (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 increases under certain conditions, including but not limited to: concurrent use of other NSAIDs (prescription or nonprescription), prolonged use beyond the recommended duration, a history of stomach ulcers or bleeding disorders, consumption of three or more alcoholic beverages daily while using this product, concurrent use of anticoagulants or steroid medications, and in patients aged 60 years or older.

Healthcare providers should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach problems (such as heartburn), asthma, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as vomiting blood, bloody or black stools, faintness, or persistent stomach pain), ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond 3 days, redness or swelling, or the emergence of new symptoms. These may signify a serious underlying condition requiring prompt medical evaluation.

Side Effects

Patients using this product should be aware of several serious adverse reactions 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. If patients experience 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.

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

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 take other medications containing 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 drugs, or are aged 60 years or older.

Patients are advised 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 persistent stomach pain. Other symptoms warranting medical attention include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the emergence of new symptoms, as these could indicate a serious condition.

Drug Interactions

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) increases the risk of severe gastrointestinal bleeding. This risk is particularly heightened when multiple NSAIDs, including prescription and nonprescription medications such as aspirin, ibuprofen, and naproxen, are taken simultaneously.

Patients are advised to consult with a healthcare professional prior to using this medication if they are currently prescribed drugs for gout, diabetes, or arthritis, as potential interactions may necessitate dosage adjustments or increased monitoring.

Additionally, the use of this medication is contraindicated in individuals who are taking anticoagulants or steroid medications. The combination of these drugs may lead to an increased risk of adverse effects, and careful consideration should be given to alternative treatment options in such cases.

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, a rare but serious illness. If 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 children under 12 years of age, the use of this product is not recommended unless directed by a doctor. In contrast, 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 healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, taking into account the increased susceptibility to complications in this age group.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later 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 the use of this medication during lactation.

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 conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly in accordance with established medical protocols.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma (wheezing). Additionally, reports have associated the use of aspirin with stomach bleeding, particularly in patients who concurrently use other prescription or nonprescription NSAIDs, exceed the recommended dosage, have a history of stomach ulcers or bleeding disorders, consume three or more alcoholic beverages daily while using the product, take anticoagulant or steroid medications, or are aged 60 years or older.

Adverse reactions documented in the postmarketing experience include signs indicative of stomach bleeding, such as vomiting blood, the presence of bloody or black stools, feelings of faintness, and persistent stomach pain. Other reported adverse reactions encompass tinnitus or hearing loss, exacerbation of pain or fever, the appearance of redness or swelling, and the emergence of new symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop using the product and contact a healthcare professional.

Furthermore, patients should be advised to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. They should also be informed to seek medical advice if they notice any redness or swelling, or if new symptoms arise, as these may indicate a serious condition.

Before using the product, patients should be encouraged to consult a doctor 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 advise patients to seek medical guidance if they have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking a diuretic or prescription medications for gout, diabetes, or arthritis should be advised to consult a doctor or pharmacist prior to use.

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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin at 20 weeks of gestation or later unless explicitly 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)