Aspirin

Description

Low Dose Aspirin is a tablet formulation containing 81 mg of aspirin as the active ingredient. This product is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is designed to provide pain relief. Each tablet is enteric coated to enhance gastrointestinal tolerance. The product is packaged in a bottle containing 100 tablets.

The tamper evident statement indicates that the product should not be used if the safety seal is broken or missing. This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, which owns the registered trademark St. Joseph® Low Dose Aspirin. It is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. It is essential to take each dose with a full glass of water to ensure proper hydration and facilitate absorption.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a physician.

Patients are cautioned against exceeding the recommended dosage.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer.

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 healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

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 certain conditions, including but not limited to: concurrent use of blood thinners or steroid medications, age 60 or older, consumption of three or more alcoholic beverages daily while using this product, prolonged use beyond the recommended duration, a history of stomach ulcers or bleeding disorders, and the use of other NSAIDs (including aspirin, ibuprofen, or naproxen).

Healthcare providers should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before using this product.

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

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: signs of an allergic reaction, 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 hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, visible redness or swelling, or the emergence of any 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. It is crucial that these individuals do not use this product. 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.

Aspirin, the active ingredient in this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients who are taking blood thinners or steroid medications, are aged 60 or older, consume three or more alcoholic drinks daily while using the product, exceed the recommended dosage or duration of use, have a history of stomach ulcers or bleeding problems, or are taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

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. Additionally, patients should seek medical advice if they notice ringing in the ears or a loss of hearing, if pain worsens or lasts longer than 10 days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if any new symptoms appear.

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. Patients with asthma or those taking diuretics should also seek medical advice prior to use. Furthermore, it is recommended that patients consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

The concomitant use of blood thinners (anticoagulants) or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. It is advised that patients avoid the use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, while using this product to mitigate the risk of adverse effects.

Patients currently prescribed medications for gout, diabetes, or arthritis should consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment with this product 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 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. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, the use of this product is not recommended unless directed by a healthcare provider. In contrast, for adolescents 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 professional.

Geriatric Use

Elderly patients, particularly those aged 60 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 of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks 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 this medication in pregnant patients.

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, 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 underlying conditions such as liver cirrhosis. It is essential for patients to disclose their liver function status to ensure appropriate management and monitoring. Adjustments to dosage or specific monitoring requirements may be necessary based on the severity of hepatic impairment. Regular assessment of liver function may be warranted to mitigate potential risks associated with the use of this medication in individuals with compromised liver function.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 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 have been reported in the available data. 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 seek immediate medical help or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. They 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. Additionally, patients should be informed to seek medical attention if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, a fever that worsens or lasts more than 3 days, redness or swelling, or any new symptoms.

Before using the medication, patients should be encouraged to consult a doctor if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to discuss any existing conditions, including high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, as well as the use of diuretics.

Furthermore, patients should be advised to speak with a doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

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)