Adult Low Dose Enteric Coated Aspirin

Description

No description information is available for the drug.

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 mentioned in the available data.

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy. Each tablet must be swallowed whole; chewing or crushing the tablets is not recommended to ensure proper release and absorption of the active ingredients.

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

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations. It is crucial to adhere to the recommended dosage and not exceed the specified limits to avoid potential adverse effects.

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 may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Therefore, individuals with known allergies to aspirin or other pain relievers/fever reducers should refrain from using this product.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased 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, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: the individual has a history of stomach bleeding, is taking a diuretic, or has a history of stomach issues such as heartburn. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice before using this product. Patients taking prescription medications for diabetes, gout, or arthritis should also consult a healthcare provider or pharmacist before use.

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

Patients should discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention is also warranted if an allergic reaction occurs, if pain worsens or persists beyond 10 days, if redness or swelling develops, if fever intensifies or lasts more than three days, if any new symptoms arise, or if there is ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious 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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product.

The 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 thinners or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients are advised to seek medical attention if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients should also be cautious and consult a doctor before using this product if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are taking diuretics or prescription medications for diabetes, gout, or arthritis.

In addition to the serious reactions mentioned, patients should discontinue use and seek medical advice if they experience worsening pain that lasts more than 10 days, redness or swelling, fever that worsens or lasts more than three days, any new symptoms, or symptoms such as ringing in the ears or loss of hearing, as these may indicate a serious condition.

For pregnant or breastfeeding patients, it is crucial 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 important 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 for appropriate dosing recommendations.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this medication. It is crucial for healthcare providers to exercise caution when prescribing this treatment to geriatric patients, especially those with a history of stomach ulcers or bleeding problems.

This medication should not be used in patients who are currently taking blood thinners (anticoagulants) or steroid drugs, or in those who are using other medications that contain prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen. Additionally, patients who consume three or more alcoholic drinks daily while using this product should be closely monitored or advised against its use.

Healthcare providers should recommend that elderly patients consult with a physician prior to using this medication if they have a history of stomach issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Monitoring and appropriate dose adjustments may be necessary to ensure the safety and efficacy of treatment 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 at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

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 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 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 for these patients to undergo careful evaluation and monitoring due to the potential impact of compromised liver function on the pharmacokinetics of the medication. Adjustments to dosage may be necessary based on the severity of liver impairment, and ongoing assessment of liver function is recommended to ensure safety and efficacy. Additionally, patients with hepatic impairment should be monitored for any adverse effects that may arise from the use of this medication.

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 specific symptoms of an 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 the specific substance is known, targeted therapies may be employed as indicated.

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

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), and shock. Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, users of other prescription or nonprescription NSAIDs, those consuming three or more alcoholic drinks daily while using aspirin, and patients exceeding the recommended dosage or duration of use.

Adverse reactions documented in postmarketing experience include signs indicative of stomach bleeding, such as feelings of faintness, vomiting blood, the presence of bloody or black stools, and persistent stomach pain. Other reported adverse reactions encompass allergic responses, exacerbation of pain, redness or swelling, worsening fever lasting more than three days, the emergence of new symptoms, and occurrences of tinnitus or hearing loss.

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 are permitted between 15°C and 30°C (59°F-86°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 4-8 tablets orally every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended before administration.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, emphasizing the importance of consulting a health professional prior to use. It is particularly critical to avoid aspirin use after 20 weeks 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 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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