Low Dose Aspirin

Description

No specific description details related to SPL code 34089-3 are provided in the text.

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.

Healthcare professionals are encouraged to inquire about additional uses for enteric-coated 81 mg Aspirin.

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. Additionally, the product should not be administered to patients who have a history of allergic reactions to this product or any of its components.

Warnings and Precautions

Patients, particularly children and teenagers, should be cautioned against the use of this product if they have or are recovering from chickenpox or flu-like symptoms 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 may be early indicators of this rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they experience any of these symptoms.

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 patients who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including prescription or over-the-counter options such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction or stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, redness or swelling occurs, new symptoms arise, or there is ringing in the ears or loss of hearing, medical advice should be sought.

In the event of an overdose, immediate medical assistance should be obtained, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

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. It is crucial that these individuals do not use this product. If patients exhibit 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.

Aspirin, the active ingredient in this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of 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 blood-thinning medications or steroids, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or a loss of hearing, medical advice should be sought.

Before using this product, patients should consult a doctor if they have asthma, if the stomach bleeding warning applies to them, if they have a history of stomach problems such as heartburn, if they are taking a diuretic, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should ask a doctor or pharmacist before use if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring for signs of bleeding in patients receiving such combinations.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, may also increase the risk of stomach bleeding. It is advisable to assess the necessity of dosage adjustments or alternative therapies in patients who are prescribed these medications concurrently.

Furthermore, patients taking prescription medications for gout, diabetes, or arthritis should consult with a healthcare provider or pharmacist prior to using this product to ensure safe and effective use. Monitoring and potential adjustments may be warranted based on individual patient circumstances.

Packaging & NDC

Below are the non-prescription pack sizes of Low Dose Aspirin (aspirin 81 mg delayed release tablets). 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 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, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, consultation with a doctor is advised prior to use.

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 at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

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 definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

Patients must be cautioned against using this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should also refrain from using the product if they have previously experienced an allergic reaction to it or any of its ingredients. In the case of an allergic reaction, patients should stop using the medication and seek medical assistance without delay.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should be advised to stop use and contact a doctor if their pain worsens or lasts longer than 10 days, if their fever intensifies or persists beyond 3 days, if they notice any redness or swelling, or if new symptoms arise. Patients should also be made aware that they should seek medical advice if they experience ringing in the ears or a loss of hearing.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor if they have asthma or if the stomach bleeding warning is applicable to them. Patients with a history of stomach problems, such as heartburn, should also seek medical advice prior to use. Furthermore, patients taking diuretics, or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, should be advised to consult a doctor before using this medication. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

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, ensuring that the storage environment does not exceed temperatures of 40°C (104°F). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

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.

View product document (PDF)