St. Joseph Low Dose Aspirin

Description

St. Joseph® Low Dose Aspirin is an enteric-coated formulation designed for adult use, providing a pain-relieving effect as a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 81 mg of aspirin, which is recognized for its efficacy in pain relief. The product is presented in a safety-coated dosage form, ensuring optimal gastrointestinal tolerance. St. Joseph® has been a trusted name in aspirin for over 100 years and is recommended by healthcare professionals. The packaging contains 36 coated tablets, suitable for a low-dose aspirin regimen.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Healthcare professionals are advised to consult with patients regarding additional potential uses for St. Joseph Safety Coated 81 mg Aspirin.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage should not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

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

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. 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 Reye's syndrome, a rare but serious condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event is increased in individuals 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 aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Individuals should refrain from using this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or asthma. Additionally, consultation with a doctor or pharmacist is recommended for those taking prescription medications for gout, diabetes, or arthritis.

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

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, ringing in the ears or hearing loss, visible redness or swelling, or the emergence of new symptoms that may suggest a serious condition.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions 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 may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. 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 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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), 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 longer than 10 days, if there is ringing in the ears or loss of hearing, if redness or swelling occurs, or if new symptoms arise, patients should seek medical advice, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, are taking diuretics, or have asthma.

Patients should not use this product if they are allergic to aspirin or any other pain reliever or fever reducer.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concomitantly with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both aspirin and these classes of drugs can increase the risk of bleeding.

Patients taking prescription medications for gout, diabetes, or arthritis should consult a healthcare professional prior to initiating aspirin therapy. This recommendation is crucial to ensure safe use and to evaluate the need for any dosage adjustments or enhanced monitoring based on the specific medications involved.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. The use of this product is contraindicated in children and teenagers who have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome.

In the event of behavioral changes accompanied by nausea and vomiting, it is essential to consult a doctor, as these may be early signs of Reye's syndrome. For patients 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 provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy, as it may pose risks to the developing fetus and could lead to complications during delivery. It is essential for healthcare providers to evaluate the necessity of aspirin in these cases and to consider alternative treatments when appropriate.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin 20 weeks or later in pregnancy unless specifically directed by a doctor, 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have 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 conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 alert to the signs of overdose and to act swiftly in accordance with established medical protocols.

Nonclinical Toxicology

It is especially important not to use aspirin 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions have been documented, including hives, facial swelling, asthma (wheezing), and shock. Additionally, gastrointestinal events such as stomach bleeding have been noted, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using other NSAIDs or blood thinners.

Further, cases of gastrointestinal bleeding and ulceration have been reported. Other adverse reactions observed in the postmarketing setting include tinnitus, hearing loss, dizziness, headache, and gastrointestinal discomfort.

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 informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is crucial to instruct patients 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 or throat, and to seek medical assistance right away.

Patients should be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should be advised to discontinue use and consult a healthcare professional if pain worsens or persists for more than 10 days, if they experience ringing in the ears or loss of hearing, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious condition.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Additionally, those taking diuretics or who have asthma should be advised to consult a healthcare professional.

Finally, patients should be encouraged to speak with their doctor or pharmacist before using the medication if they are currently taking prescription drugs for gout, diabetes, or arthritis to avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy. After each use, it is essential to close the cap tightly to maintain the integrity of the product and prevent contamination.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years of age, use is not recommended unless specifically directed by a healthcare provider.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is crucial for patients to consult a healthcare professional before use if they are pregnant or breastfeeding. Notably, aspirin should not be used after 20 weeks of pregnancy unless explicitly directed by a doctor, 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 St. Joseph Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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