Aspirin

Description

LOW DOSE ASPIRIN 81 mg PAIN RELIEVER (NSAID) is a quality formulation containing 81 mg of aspirin per tablet, designed for pain relief. The product is available in a dosage form of 120 enteric-coated tablets, which are specifically designed to minimize gastrointestinal irritation. The tablets are safety coated and feature a tamper-evident seal; they should not be used if the safety seal under the cap is broken or missing. This product is comparable to the active ingredient found in Bayer® Low Dose Aspirin. It is distributed by LNK International, Inc., located at 60 Arkay Drive, Hauppauge, NY 11788, USA. The National Drug Code (NDC) for this product is 50844-600-32.

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 and not exceed the directed amount. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily intake must 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 advised 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

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

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 may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

Stomach Bleeding Warning 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 the following circumstances:

• Patients aged 60 years or older

• Those who exceed the recommended dosage or duration of use

• Individuals with a history of stomach ulcers or bleeding disorders

• Patients concurrently using blood thinners (anticoagulants) or steroid medications

• Individuals consuming three or more alcoholic beverages daily while using this product

• Patients taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen

General Precautions Prior to use, patients should consult a healthcare provider if any of the following conditions apply:

• A history of stomach problems, such as heartburn

• High blood pressure, heart disease, liver cirrhosis, or kidney disease

• Asthma

• Use of diuretics

Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently taking prescription medications for gout, diabetes, or arthritis.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Discontinuation and Consultation Patients should cease use and contact a healthcare professional if any of the following occur:

• Signs of an allergic reaction, which require urgent medical attention

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

• Ringing in the ears or loss of hearing

• Worsening pain that lasts more than 10 days

• Fever that worsens or persists beyond three days

• Presence of redness or swelling

• Onset of new symptoms

These signs may indicate a serious medical condition that requires prompt evaluation.

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 may be early signs 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 help right away.

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, those who take more of the product or for a longer duration than directed, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners (anticoagulants) or steroid medications. Furthermore, patients who consume three or more alcoholic drinks daily while using this product or who take other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen, are at an increased risk.

Patients are advised to stop using the product 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 concerning symptoms that warrant 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

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both classes of drugs can exacerbate the risk of bleeding.

Additionally, the concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, may further elevate the risk of stomach bleeding. This interaction underscores the importance of careful monitoring and consideration of alternative pain management strategies when multiple NSAIDs are involved.

Patients who are prescribed medications for gout, diabetes, or arthritis should consult their healthcare provider prior to initiating aspirin therapy. These prescription drugs may interact with aspirin, necessitating dosage adjustments or enhanced monitoring to mitigate potential adverse effects.

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 unless directed by a healthcare professional. For children and teenagers who have or are recovering from chickenpox or flu-like symptoms, the use of this product is contraindicated due to the risk of Reye's syndrome, a rare but serious illness.

In the event of changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

For patients 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 provider.

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, and careful evaluation of the benefits versus risks should guide treatment decisions in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential for healthcare providers to evaluate the necessity of aspirin in these circumstances and to consider alternative treatments when appropriate.

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 gestation 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

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 aged 60 years or older, those who exceed the recommended dosage, individuals with a history of stomach ulcers or bleeding disorders, patients taking blood thinners or steroid medications, those consuming three or more alcoholic beverages daily while using aspirin, and individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.

Adverse reactions documented in 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, localized redness or swelling, and the emergence of new symptoms.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately in the event of an overdose. It is important to inform patients that they should not use this product if they are allergic to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Healthcare providers should instruct patients to stop using the product and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away. Patients should also be made aware of the signs of stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing stomach pain that does not improve. They should be advised to discontinue use and consult a doctor if any of these symptoms occur.

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

Before using the product, patients should be encouraged to ask a doctor if the warning regarding stomach bleeding applies to them. It is also essential to advise patients to consult a doctor before use 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. Patients with asthma should also be advised to seek medical advice prior to use. Furthermore, patients taking a diuretic or those on prescription medications for gout, diabetes, or arthritis should be encouraged to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)