Enteric Coated 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 action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

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

Dosage and Administration

Patients should take 4 to 8 tablets every 4 hours as needed. The total dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

It is recommended that each dose be accompanied by a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, consultation with a healthcare provider is advised prior to use. Additionally, for children under 12 years of age, it is essential to seek medical advice before administration.

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

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. The use of this product in these populations may pose significant health risks.

When using this product, healthcare professionals should be vigilant for changes in behavior accompanied by nausea and vomiting, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition. Immediate consultation with a physician is advised if such symptoms occur.

Aspirin, a component of this product, has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Healthcare providers should be aware of these risks and monitor patients accordingly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, 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.

General precautions should be taken prior to the use of this product. Healthcare professionals should advise patients to consult a physician 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 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 (1-800-222-1222) should be contacted without delay.

Patients should be instructed to discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additional symptoms warranting medical consultation include a fever that worsens or lasts more than three days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions.

Serious adverse reactions include the potential for severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Additionally, the product carries a warning for stomach bleeding, particularly 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, or exceed the recommended dosage. Symptoms indicative of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain that does not improve. Patients should seek immediate medical attention if any of these symptoms occur.

Patients, particularly children and teenagers recovering from chickenpox or flu-like symptoms, should avoid using 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, it is crucial to consult a healthcare provider.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to stop use and consult a doctor if they experience any new symptoms, worsening pain, or if fever persists beyond three days.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics or other medications for gout, diabetes, or arthritis.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulant medications or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. This interaction necessitates careful consideration of the concomitant use of these agents.

Additionally, it is advised that patients consult a healthcare professional prior to using aspirin if they are currently prescribed medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective management of their conditions while minimizing the risk of adverse interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to consult a doctor for dosing recommendations, particularly for children under 12 years of age. For patients aged 12 years and older, adult dosing may be applicable, but medical guidance is still advised.

Healthcare professionals should be vigilant for changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye’s syndrome, a rare but serious condition. Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

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). It is crucial for healthcare providers to advise these patients to consult a physician prior to use if they have any concerns related to stomach bleeding.

Additionally, geriatric patients with a history of gastrointestinal issues, including heartburn, as well as those with comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, should seek medical advice before initiating treatment. This is especially important for patients aged 60 and older, as their risk factors may necessitate closer monitoring and potential dosage adjustments to ensure safety and efficacy.

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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the degree of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy. Special caution should be exercised in patients with significant hepatic impairment, as they may be at increased risk for adverse effects.

Patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be closely monitored, as these factors may further complicate the management of their hepatic condition.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is necessary to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety and to facilitate timely interventions as needed.

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 current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs. Allergic reactions have been noted, including hives, facial swelling, asthma (wheezing), and shock. Additionally, stomach bleeding has been reported, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood thinning (anticoagulant) or steroid medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Changes in behavior accompanied by nausea and vomiting may represent early signs of Reye’s syndrome, a rare but serious illness.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay. Additionally, they should be informed to stop use and contact a healthcare professional if they notice any symptoms indicative of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Patients should also be aware that a fever lasting more than 3 days, the presence of redness or swelling, the emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing warrant immediate medical consultation.

It is important for healthcare providers to remind patients to consult a doctor before using the medication 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 be advised to seek medical advice prior to use. Furthermore, those taking diuretics or who have asthma should consult a healthcare professional before starting the medication. Lastly, patients should be encouraged to speak with their 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 upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible between 15°C and 30°C (59°F to 86°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 4 to 8 tablets every 4 hours, not to exceed 48 tablets within a 24-hour period unless directed by a healthcare professional.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, advising them to consult a health professional prior to use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically instructed 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 Enteric Coated Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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