Aspirin

Description

Aspirin, with an NDC of 0363-0157-98, is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. Each tablet contains 325 mg of aspirin and is classified as regular strength. The product is packaged in a bottle containing 100 tablets. It features a tamper-evident seal, and users are advised not to use the product if the safety seal under the cap is broken or missing. This medication is distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, headache, muscle pain, menstrual pain, toothache, and 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. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is as follows: 1 or 2 tablets may be taken every 4 hours, or alternatively, 3 tablets may be taken 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 physician.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early indicators of Reye's syndrome.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include facial swelling, shock, hives, and asthma (wheezing). Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they 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 patients who are 60 years of age or older, those taking anticoagulants or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), and patients who exceed the recommended dosage or duration of use. A history of stomach ulcers or bleeding problems, as well as the consumption of three or more alcoholic drinks daily while using this product, further elevates the risk of gastrointestinal complications.

Healthcare professionals should advise patients to consult a doctor prior to use if they are currently taking diuretics, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare provider or pharmacist before using this product.

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

Patients should be instructed to discontinue use and contact their doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling. They should also seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, persistent stomach pain, or feelings of faintness. Other concerning symptoms warranting medical consultation include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate serious underlying conditions.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, 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 symptoms may indicate the onset of Reye's syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as facial swelling, shock, hives, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical assistance without delay.

This 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, those taking blood thinners (anticoagulants) or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), and patients with a history of stomach ulcers or bleeding problems. Furthermore, the risk is heightened for those who consume three or more alcoholic drinks daily while using this product or who exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, persistent stomach pain, or feelings of faintness. Other concerning symptoms that warrant medical attention include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms could signify a serious underlying condition that requires prompt evaluation.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together.

The co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also heightens the risk of severe stomach bleeding. It is advisable for patients to avoid using multiple NSAIDs concurrently.

Patients taking diuretics should consult with their healthcare provider prior to initiating treatment, as potential interactions may necessitate dosage adjustments or increased monitoring.

Additionally, individuals on prescription medications for gout, diabetes, or arthritis are encouraged to seek guidance from a healthcare professional or pharmacist before starting new treatments to ensure safety and efficacy.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a healthcare professional. 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 physician.

Caution is advised for children and teenagers who have or are recovering from chickenpox or flu-like symptoms, as they are at risk for Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare provider should be consulted immediately, as these may be early signs of this rare but serious condition.

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 signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the benefits and risks is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

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, 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 comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as liver cirrhosis. It is essential for patients to disclose their liver function status to ensure appropriate management and monitoring. Due to the potential impact of hepatic impairment on drug metabolism and clearance, careful consideration of dosage adjustments may be necessary. Regular monitoring of liver function tests is recommended to assess the patient's hepatic status and to guide treatment decisions.

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 interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly to ensure the safety and well-being of the patient in the event of an overdose.

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

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

Adverse reactions documented in the postmarketing experience include signs indicative of stomach bleeding, such as vomiting blood, the presence of bloody or black stools, and persistent stomach pain. Other reported adverse reactions encompass tinnitus or hearing loss, exacerbation of pain or fever, the emergence of new symptoms, and the occurrence of redness or swelling.

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 crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or feeling faint. If any of these symptoms occur, patients should stop using the product and contact a healthcare professional.

Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. They should also be advised to seek medical advice if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

Before initiating treatment, patients should be encouraged to consult a doctor if they are taking a diuretic, have a history of stomach problems such as heartburn, or if the warning for stomach bleeding applies to them. It is also important to discuss any existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as asthma. Patients taking prescription medications for gout, diabetes, or arthritis should be advised to consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied with an expiration date clearly indicated on the package. It should be stored at a controlled room temperature of 25ºC (77ºF). Temporary excursions are permissible within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should counsel patients on the importance of avoiding aspirin use at 20 weeks of gestation or later unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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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