St. Joseph Chewable Low Dose Aspirin

Description

ST. JOSEPH® LOW DOSE ASPIRIN is a chewable nonsteroidal anti-inflammatory drug (NSAID) formulated to provide pain relief. Each tablet contains 81 mg of aspirin and is presented in an orange flavor. The product is packaged in a bottle containing 36 chewable tablets.

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 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, the use of this medication is not recommended unless specifically directed by a physician.

Contraindications

Use is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, the product should not be administered for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

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.

Healthcare professionals should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently prescribed medications for gout, diabetes, or arthritis.

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

Patients are advised to discontinue use and consult a physician if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or persists beyond 10 days, if there is ringing in the ears or loss of hearing, if redness or swelling occurs, or if new symptoms arise, medical consultation is necessary, as these may signify a serious condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Serious adverse reactions include the risk of Reye's syndrome, particularly 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 this rare but serious illness.

Allergic reactions to aspirin can also occur, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should seek immediate medical attention if any signs of an allergic reaction develop.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for 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 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 are advised not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer, or for at least seven days following a tonsillectomy or oral surgery unless directed by a healthcare professional.

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, or if they are taking diuretics or have asthma.

Patients should discontinue use and seek medical advice if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), worsening pain lasting more than ten days, ringing in the ears or loss of hearing, redness or swelling, or the emergence of new symptoms that could signify a serious condition.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered 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 are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to using aspirin if they are concurrently taking prescription medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use, as these conditions may influence the overall therapeutic regimen and the risk of adverse effects. Monitoring for signs of gastrointestinal bleeding is recommended in patients receiving aspirin alongside these medications.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important for healthcare professionals to advise parents and caregivers to consult a doctor if their child exhibits changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye's syndrome.

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

Geriatric Use

Elderly patients, particularly those aged 60 years 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 and safety of aspirin use in this population to mitigate potential adverse fetal outcomes.

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 comorbid 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 degree 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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 or nonclinical toxicology details are available in the provided data. Additionally, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product, including hives, facial swelling, asthma (wheezing), and shock. Additionally, severe allergic reactions may occur with the use of aspirin.

The product has been associated with the potential for severe stomach bleeding, particularly in individuals who are age 60 or older, have a history of stomach ulcers or bleeding problems, are taking blood thinning (anticoagulant) or steroid medications, are using other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), consume three or more alcoholic drinks daily while using this product, or exceed the recommended duration or dosage.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Healthcare providers should inform patients not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using this medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, which may require immediate medical attention. They should also be made aware of the signs of potential stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If pain worsens or persists for more than 10 days, patients should seek medical advice.

It is important to advise patients to discontinue use and consult a doctor if they experience ringing in the ears, loss of hearing, redness, swelling, or any new symptoms that may indicate a serious condition. Patients should be encouraged to ask a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Furthermore, patients should be advised to consult a healthcare provider before use if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or who have asthma should also seek medical advice prior to use. 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 a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature of 20-25°C (68-77°F) to maintain its efficacy and stability.

After each use, it is crucial to ensure that the cap is closed tightly to prevent contamination and preserve the integrity of the product. Proper handling and storage conditions are vital for optimal performance and safety.

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 the use of aspirin after 20 weeks 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 St. Joseph Chewable Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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