Aspirin 81 mg Enteric Coated

Description

Aspirin, with a National Drug Code (NDC) of 10135-0173-62, is a nonsteroidal anti-inflammatory drug (NSAID) formulated in a low strength of 81 mg per tablet. Each enteric-coated tablet contains 1 ¼ grains (81 mg) of aspirin, designed to provide analgesic effects. The enteric coating facilitates the release of the active ingredient in the intestine, minimizing gastrointestinal irritation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Due to its delayed action, it is not suitable for the fast relief of headaches or other symptoms requiring immediate alleviation. Healthcare professionals are encouraged to consult with patients regarding additional potential uses for enteric-coated 81 mg Aspirin.

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

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, it is advised to consult a physician for appropriate dosing recommendations.

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 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 illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

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: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics. Additionally, patients with asthma, those who have not been adequately hydrating, or those who have experienced significant fluid loss due to vomiting or diarrhea should seek medical advice before using this product.

Patients should also be encouraged to consult a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

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

Patients must discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of potential stomach bleeding: feeling faint, having bloody or black stools, vomiting blood, experiencing persistent or worsening stomach pain lasting more than 10 days, noticing redness or swelling, developing new symptoms, or experiencing ringing in the ears or loss of hearing. These symptoms may signify a serious medical condition that requires prompt attention.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings 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. It is crucial for these individuals to avoid using 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 could indicate the onset of Reye's syndrome.

Aspirin, the active ingredient in this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood 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, 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 should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve, worsens, or lasts more than 10 days. Additionally, the presence of redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing should prompt immediate medical consultation.

Before using this product, patients should seek medical advice 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. Patients with asthma, those who have not been adequately hydrated, or those who have lost significant fluid due to vomiting or diarrhea should also consult a doctor prior to use.

Furthermore, patients should ask a doctor or pharmacist before using this product if they are taking prescription medications for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience significant drug interactions. The concomitant use of these agents can increase the risk of bleeding or other adverse effects. It is advisable to monitor patients closely for signs of bleeding and to consider dosage adjustments as necessary based on clinical response.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, can also lead to interactions. Co-administration of NSAIDs with anticoagulants or steroids may further elevate the risk of gastrointestinal bleeding and other complications. Clinicians should exercise caution and monitor patients for any adverse effects, adjusting dosages as appropriate.

Additionally, patients on prescription medications for diabetes, gout, or arthritis should be evaluated for potential interactions. The specific effects of these interactions were not detailed, but careful monitoring and possible dosage adjustments may be warranted to ensure patient safety and therapeutic efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 mg Enteric Coated (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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years, consultation with a doctor is advised before use.

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 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 the unborn child or complications during delivery. Therefore, it is essential that pregnant women only use aspirin in this period if explicitly directed by a physician. Additionally, breastfeeding patients should also seek advice from a healthcare provider prior to use.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of 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 while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable for patients to seek medical advice if they have not been adequately hydrated or have experienced significant fluid loss due to vomiting or diarrhea. These conditions may necessitate careful monitoring and potential dosing adjustments to ensure safety and efficacy in this population.

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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

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 act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 additional relevant information regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology has been extracted.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away in such cases.

It is important for healthcare providers to discuss the signs of potential stomach bleeding with patients. They should instruct patients to discontinue use and contact a doctor if they experience symptoms such as feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve, worsens, or lasts more than 10 days, especially if accompanied by redness or swelling. Patients should also be advised to report any new symptoms, as well as any ringing in the ears or loss of hearing, as these could indicate a serious condition.

Healthcare providers should encourage 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. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics, should be advised to seek medical advice prior to use.

Patients with asthma should also be encouraged to consult a doctor before using the medication. Furthermore, healthcare providers should remind patients to seek medical advice if they have not been drinking fluids or have lost a significant amount of fluid due to vomiting or diarrhea.

Lastly, patients should be counseled to speak with a doctor or pharmacist before using the medication if they are taking prescription drugs for diabetes, gout, or arthritis, or any other medications, and if they are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should store the medication at a temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is important for patients to adhere to the expiration date indicated on the package to ensure the medication's efficacy and safety.

Drug Information (PDF)

This file contains official product information for Aspirin 81 mg Enteric Coated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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