Adult Low Dose Enteric Coated Aspirin

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 other potential uses for aspirin.

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

Dosage and Administration

Patients should adhere to the recommended dosage and not exceed the specified limits. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed. The maximum allowable dosage is 48 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

It is essential for patients to drink a full glass of water with each dose. Tablets should be swallowed whole; they must not be chewed or crushed to ensure proper absorption and efficacy.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

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 this rare but serious condition.

Aspirin has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Individuals with a known allergy to aspirin or any other pain reliever or fever reducer should refrain from using this product. Additionally, those who have previously experienced an allergic reaction to this product or any of its ingredients should avoid its use.

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 beverages daily while using this product, or exceed the recommended dosage or duration of use.

Before using this product, individuals should consult a healthcare professional if any of the following apply: the stomach bleeding warning is relevant, they are taking a diuretic, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the individual is currently taking prescription medications for diabetes, gout, or arthritis.

Users should discontinue use and consult a healthcare professional immediately if they experience any signs of an allergic reaction, such as difficulty breathing or swelling. Additionally, signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, warrant immediate medical attention. If pain worsens or persists for more than 10 days, if redness or swelling occurs, if fever intensifies or lasts more than three days, or if any new symptoms arise, medical advice should be sought. Users should also report any instances of ringing in the ears or loss of hearing.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before using this product. Aspirin should be avoided after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Patients should not use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product. Additionally, individuals who have previously experienced an allergic reaction to this product or any of its ingredients should avoid its use.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to 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 this product, or exceed the recommended dosage or duration of use.

Patients are advised to consult a doctor before using this product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also seek medical advice prior to use. Furthermore, individuals taking prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this product.

Patients should discontinue use and seek medical attention if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, redness or swelling, fever lasting more than three days, the emergence of new symptoms, or ringing in the ears or loss of hearing.

For pregnant or breastfeeding patients, it is essential to consult a healthcare professional before use. Aspirin should particularly be avoided after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The concomitant use of anticoagulants or steroid medications significantly elevates the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, further increases the risk of severe stomach bleeding. It is advisable for patients to avoid combining these medications without consulting a healthcare provider.

Patients currently on diuretics should seek medical advice prior to initiating treatment with this drug. Furthermore, individuals taking prescription medications for diabetes, gout, or arthritis are encouraged to consult with a healthcare professional or pharmacist before use to ensure safe co-administration.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Adult Low Dose Enteric Coated Aspirin (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, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 4-8 tablets every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a doctor. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to advise these patients to consult a physician prior to use if they have a history of stomach ulcers or bleeding problems, as the stomach bleeding warning is particularly pertinent in this age group.

Additionally, geriatric patients may exhibit heightened sensitivity to side effects. Therefore, careful monitoring and consideration of dose adjustments may be necessary to ensure safety and efficacy in this population.

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 explicitly 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 unless specifically 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Patients with compromised liver function may be at an increased risk for adverse effects, and careful evaluation of their overall health status, including any coexisting conditions such as high blood pressure, heart disease, kidney disease, or asthma, is recommended. Regular monitoring of liver function tests may be warranted to ensure patient safety and therapeutic efficacy.

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 specific 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. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Temporary excursions outside this range are permissible, provided the temperature does not exceed 30°C (86°F) or drop below 15°C (59°F). Proper container requirements must be adhered to, and special handling considerations should be observed to maintain product integrity.

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 at 20 weeks of gestation or later 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 Adult Low Dose Enteric Coated Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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