Aspirin

Description

HONEYWELL ASPIRIN TABLET is formulated as a 325 mg tablet. It is identified by the National Drug Code (NDC) 022125 and is regulated under the Center for Drug Evaluation and Research (CDER). The tablet is designed for oral administration and is intended for use in various therapeutic applications.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, toothache, menstrual pain, muscle pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever associated with colds.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage, and an overdose warning is in place.

For oral administration, each dose should be taken with a full glass of water.

In adults and children aged 12 years and older, the recommended dosage is as follows:

• Take 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. The total daily dosage must not exceed 12 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 healthcare provider.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients who have a history of allergic reactions to this product or any of its ingredients should not use it, as this may lead to severe adverse reactions.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chicken pox 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, which can manifest as facial swelling, hives, shock, or asthma symptoms such as wheezing. Immediate medical attention is warranted if an allergic reaction occurs.

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 with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals aged 60 years or older, and those who consume three or more alcoholic drinks daily while using this product. Additionally, the risk is heightened for patients taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen, or for those who exceed the recommended dosage or duration of use.

General precautions should be observed, particularly in patients with a history of stomach issues such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions may further increase the risk of stomach bleeding.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a poison control center immediately.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody stools, or persistent stomach pain), or if they notice ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or a fever that persists beyond three days. New symptoms, redness, or swelling should also prompt immediate medical evaluation, as these may signal a serious condition.

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 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 could indicate the onset of Reye's Syndrome.

Severe allergic reactions to aspirin may occur, presenting as facial swelling, hives, shock, or 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 with a history of stomach ulcers or bleeding problems, those taking blood-thinning medications or steroids, individuals aged 60 or older, and those consuming three or more alcoholic drinks daily while using this product. Additionally, the risk increases if patients take other medications containing NSAIDs, such as aspirin, ibuprofen, or naproxen, or if they 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, vomiting blood, having bloody stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical attention include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should seek advice from a healthcare professional prior to use.

Drug Interactions

Aspirin has the potential to induce severe allergic reactions, which may manifest as shock or asthma symptoms, including wheezing.

When considering the concomitant use of aspirin with anticoagulant medications or steroid drugs, it is important to note that the risk of severe gastrointestinal bleeding is significantly increased. Therefore, careful monitoring and assessment of the patient's overall risk factors for bleeding should be conducted.

Additionally, patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to using aspirin if they are currently prescribed medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in conjunction with these therapies.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a doctor. The use of this product is contraindicated in children and teenagers who have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's Syndrome. Healthcare professionals should advise caregivers to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye's Syndrome.

For adolescents aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to inquire about any history of stomach problems, such as heartburn, as well as any existing conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may necessitate closer monitoring or dosage adjustments to ensure the safety and efficacy of the treatment in geriatric patients.

Pregnancy

Pregnant patients 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 explicitly 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 while breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management and follow-up care.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a poison control center in the event of an overdose. It is important to discuss any known allergies, particularly to aspirin or other pain relievers and fever reducers, as well as any previous allergic reactions to this product or its ingredients.

Patients should be informed to watch for signs of an allergic reaction, which necessitate prompt medical attention. Additionally, they should be made aware of the symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody stools, or experiencing persistent stomach pain. If patients experience ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or a fever that persists beyond 3 days, they should be instructed to seek medical advice.

Healthcare providers should emphasize the importance of reporting any new symptoms, as well as any redness or swelling, as these may signal a serious condition. It is crucial to assess whether the stomach bleeding warning applies to the patient, especially if they have a history of stomach problems, such as heartburn, or if they have asthma.

Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be counseled on the potential risks associated with the use of this product. Furthermore, those taking diuretics or prescription medications for gout, diabetes, or arthritis should be advised to discuss their current medications with their healthcare provider to ensure safe use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number, ensuring that the product is used by the expiration date indicated. It is important to note that the packaging is tamper evident; therefore, the product should not be used if the packet is open or torn. Additionally, the product must be kept out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly critical to avoid the use of aspirin at 20 weeks of gestation or later unless explicitly 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 Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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