Low Dose Aspirin

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as recommended by a healthcare professional. Due to its delayed release formulation, this product is not intended for the rapid alleviation of headaches or other symptoms requiring immediate relief.

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 as needed for symptom relief. It is imperative that patients do not exceed a total of 48 tablets within a 24-hour period unless specifically 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 patients who experience any of the following:

• Signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain.

• Allergic reactions, which require immediate medical attention.

• Symptoms of tinnitus or hearing loss.

• Worsening pain that persists beyond 10 days.

• Fever that worsens or lasts longer than 3 days.

• Redness or swelling in the affected area.

• The emergence of new symptoms.

In these situations, discontinuation of the product and consultation with a healthcare professional is advised.

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, shock, facial swelling, or asthma symptoms such as wheezing. Patients with known allergies to aspirin or other pain relievers/fever reducers should not use this product.

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 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 thinners (anticoagulants) or steroid medications, or other NSAIDs (including aspirin, ibuprofen, or naproxen)

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

• Exceed the recommended dosage or duration of use

Discontinuation of Use Patients should discontinue use and seek medical advice if any of the following occur:

• Signs of stomach bleeding, including feeling faint, experiencing bloody or black stools, vomiting blood, or persistent stomach pain

• Any allergic reaction, which requires immediate medical attention

• Symptoms such as ringing in the ears or hearing loss

• Worsening pain that persists beyond 10 days

• Fever that worsens or lasts longer than 3 days

• Redness or swelling in the affected area

• The emergence of new symptoms

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

No specific laboratory tests are recommended for monitoring during the use of this product. However, healthcare professionals should remain vigilant for the aforementioned signs and symptoms to ensure patient safety.

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 symptoms may indicate the onset of Reye's syndrome.

Additionally, this product may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

The 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, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other symptoms warranting medical consultation include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling in the painful area, or the emergence of new symptoms.

Before using this product, patients should seek medical advice if they have asthma, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, are under a doctor's care for any serious condition, or are using any other drugs.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question.

Additionally, the concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, is associated with an increased risk of severe stomach bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating any NSAID therapy.

Patients who are currently prescribed medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before using this drug. Furthermore, individuals under medical supervision for serious health conditions or those taking other medications should also consult their doctor to ensure safe use.

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

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

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, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For children under 12 years of age, it is advised to consult a doctor before use. The product should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or the Poison Control Center (1-800-222-1222) contacted, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours while symptoms persist, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially those with a history of gastrointestinal issues, such as heartburn.

Before initiating treatment, healthcare providers should inquire about the presence of any stomach bleeding warnings applicable to the patient. Additionally, it is crucial to assess the patient's medical history for conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these factors may further elevate the risk of adverse effects associated with NSAID use.

Monitoring and appropriate dose adjustments may be necessary for elderly patients to ensure safety and efficacy while minimizing the potential for serious complications.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. Aspirin is contraindicated during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of aspirin in pregnant patients, particularly in the later stages of pregnancy.

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 the use of this medication in lactating mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

Overdosage

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with overdose may include nausea, vomiting, and abdominal pain.

In the event of an overdose, it is imperative to seek immediate medical attention. Additionally, contacting a Poison Control Center is strongly recommended to ensure appropriate management and intervention. Prompt action is crucial to mitigate potential harm and provide the necessary care for affected individuals.

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

No specific postmarketing experience details are available in the provided text. As such, there are no reported adverse events or case reports to summarize.

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 immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed 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, they should seek immediate medical assistance if they notice an allergic reaction, ringing in the ears, or loss of hearing. Patients should also be advised to contact a healthcare professional if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond 3 days, if there is redness or swelling in the painful area, or if new symptoms arise, as these could indicate a serious condition.

It is important for patients to consult a doctor before using the medication if they have asthma or if the stomach bleeding warning applies to them. Patients with a history of stomach problems, such as heartburn, should also seek medical advice prior to use. Furthermore, those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should discuss their conditions with a healthcare provider before taking the medication. Patients taking diuretics or any prescription drugs for diabetes, gout, or arthritis should consult a doctor or pharmacist before use. Lastly, individuals under a doctor's care for any serious condition should also seek guidance before using this medication, as well as those taking any other drugs.

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 at room temperature, maintaining a range of 20º to 25º C (68º to 77º F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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 Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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