Low Dose Aspirin

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "A" on one side and "123" on the other side. It contains 500 mg of Acetaminophen as the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses beyond this indication. The use of this drug should not exceed 10 days without medical consultation, as serious side effects may occur with prolonged use.

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

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

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

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use 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 has the potential to cause severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may include hives, facial swelling, shock, and asthma symptoms such as wheezing.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk is heightened in individuals who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood-thinning medications (anticoagulants) or steroid drugs

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

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

Monitoring and Consultation Patients should be instructed to discontinue use and seek medical advice 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. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is warranted. Patients should also report any occurrences of ringing in the ears or hearing loss.

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

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 should be vigilant for these symptoms and seek medical attention if they occur.

The 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, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, exceed the recommended dosage, or use other medications containing NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients are advised to discontinue use and consult a doctor 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 seek medical advice include worsening pain lasting more than 10 days, fever lasting more than 3 days, the presence of redness or swelling in the painful area, the emergence of 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 important to seek medical advice if they are taking diuretics, have asthma, have not been adequately hydrated, or have lost significant fluid due to vomiting or diarrhea. Furthermore, patients should inform their healthcare provider if they are taking prescription medications for diabetes, gout, or arthritis, or any other drugs, especially if they are under medical care for any serious condition.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with anticoagulants or steroid medications. This risk is notably elevated in patients who are also taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as ibuprofen and naproxen.

Patients are advised to consult a healthcare professional prior to using aspirin if they are currently prescribed medications for diabetes, gout, or arthritis. Monitoring for signs of gastrointestinal bleeding is recommended in patients who are taking aspirin alongside other NSAIDs or blood-thinning agents. Adjustments to dosage or alternative therapies may be necessary based on individual risk factors and concurrent medication use.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals should advise caregivers to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye's syndrome.

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 24 hours unless otherwise directed by a physician. For children under 12 years, it is essential to consult a doctor before use to ensure safety and appropriate dosing.

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 medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of stomach bleeding, such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. A thorough assessment of the patient's medical history and current health status is crucial to ensure safe and effective use of the medication in geriatric patients.

Monitoring for signs of gastrointestinal bleeding is recommended in elderly patients, especially those with pre-existing risk factors. Adjustments to dosage or alternative therapeutic options may be necessary based on individual patient assessments.

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 fetal outcomes or 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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. Reports include gastrointestinal bleeding, which has been noted to have an increased risk in specific patient populations. These populations include individuals aged 60 years or older, those with a history of stomach ulcers or bleeding problems, patients taking anticoagulants or steroid medications, individuals consuming three or more alcoholic drinks daily while using the product, those using higher doses or for longer than directed, and patients concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription.

Additionally, allergic reactions have been reported, including hives, facial swelling, shock, and asthma symptoms such as wheezing. There have also been cases of Reye's syndrome observed in children and teenagers recovering from chickenpox or flu-like symptoms.

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 cautioned against using the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important to inform patients to discontinue use and consult a doctor 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. 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, or if any new symptoms arise. Patients should also be made aware that ringing in the ears or loss of hearing should prompt them to contact their healthcare provider.

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 they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals who have not been adequately hydrating or have lost significant fluids due to vomiting or diarrhea should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor or pharmacist before using the medication if they are taking prescription drugs for diabetes, gout, or arthritis, or if they are currently taking any other medications. It is essential for patients under a doctor's care for any serious condition to discuss their treatment options with their healthcare provider before using this medication.

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). Temporary excursions are permissible 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 aspirin during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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