Low Dose Aspirin

Description

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

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 important not to 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 the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• Discontinue use and consult a healthcare professional if any of the following occur: signs of stomach bleeding (e.g., feeling faint, bloody or black stools, vomiting blood, persistent stomach pain), allergic reactions, tinnitus or hearing loss, worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the affected area, or the emergence of new symptoms.

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 physician, as these symptoms may indicate the onset of this rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). Healthcare professionals should be vigilant for these signs and advise patients accordingly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use. Patients with known allergies to aspirin or other pain relievers/fever reducers should avoid this product.

Healthcare providers should recommend that patients consult a physician prior to use if they have asthma, a history of stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics. Additionally, patients should seek advice from a doctor or pharmacist if they are on prescription medications for diabetes, gout, or arthritis, are under medical supervision for any serious condition, or are taking any other medications.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

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

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings 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 changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional, as these may be early signs of Reye's syndrome.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms can include hives, shock, facial swelling, and asthma (wheezing). Immediate medical attention should be sought if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk 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 while using this product, or exceed the recommended dosage or duration of use.

Patients should 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 an allergic reaction occurs, medical help should be sought immediately. Other concerning symptoms that warrant medical consultation 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 in the painful area, or the emergence of new symptoms.

Before using this product, patients should consult a healthcare professional 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 seek medical advice if taking diuretics or any prescription drugs for diabetes, gout, or arthritis, or if under a doctor's care for any serious condition.

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 together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, can further increase the likelihood 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 medication. Furthermore, individuals under medical supervision for serious health conditions or those taking other medications should also consult their healthcare provider to ensure safe and effective 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 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 essential to consult a doctor, as these may be early signs of Reye's syndrome.

For children under 12 years of age, it is advised to consult a doctor before use. Additionally, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). The risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Additionally, it is crucial to ensure that elderly patients adhere to the recommended dosage and duration of treatment to minimize the risk of adverse effects.

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 development and 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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 text.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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

Patients should be instructed 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 stomach pain that does not improve. Additionally, they should seek immediate medical assistance if they notice an allergic reaction, ringing in the ears, or loss of hearing. Patients should also report if their pain worsens or persists for more than 10 days, if a fever intensifies or lasts longer than 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 warning regarding stomach bleeding applies to them. They should also seek medical advice 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 should also consult a doctor prior to use.

Furthermore, patients should be encouraged to speak with a doctor or pharmacist before using the medication if they are taking prescription drugs for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition. Lastly, patients should be reminded to consult a doctor or pharmacist if they are taking any other medications.

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 15°C to 30°C (59°F to 86°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 counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Patients should also be advised to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

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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