Aspirin

Description

This product contains Aspirin as the active ingredient, with a dosage of 325 mg per tablet. It functions as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief and fever reduction. The product is presented in a coated tablet form, with a total of 100 tablets per container. The National Drug Code (NDC) for this product is 70677-1189-1. It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Genuine Bayer® Aspirin. The packaging includes a tamper-evident safety seal; the product should not be used if this seal is broken or missing. Distribution is managed by McKesson Corp., through Strategic Sourcing Services LLC, located in Memphis, TN 38141. For further information, visit www.fosterandthrive.com.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, pain and fever associated with colds, toothache, menstrual pain, muscle pain, and minor pain related to arthritis.

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.

For 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 specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless directed by a physician.

Patients are advised to consume a full glass of water with each dose to ensure proper administration and absorption of the medication.

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.

Aspirin may induce severe allergic reactions, which can manifest as facial swelling, hives, shock, or asthma symptoms such as 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 taking anticoagulants or steroid medications, are aged 60 years or older, are using other NSAIDs (including prescription and nonprescription options such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, have a history of stomach ulcers or bleeding problems, 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), asthma, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are currently taking a diuretic.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they notice any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical advice if they experience ringing in the ears or hearing loss, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise, as these may indicate 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. 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 symptoms could indicate the onset of Reye's syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as facial swelling, hives, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help immediately.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction increases in patients who are taking blood thinners or steroid medications, are aged 60 or older, are consuming three or more alcoholic drinks daily while using the product, have a history of stomach ulcers or bleeding problems, or are taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop using the product and consult a doctor.

Patients are advised to seek medical advice before using this product if they have a history of stomach problems, such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also recommended to consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Patients should discontinue use and consult a healthcare professional if they experience ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or the emergence of new symptoms, as these may indicate a serious condition.

Drug Interactions

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), is associated with an increased risk of severe stomach bleeding, particularly under certain conditions.

Pharmacodynamic Interactions:

The risk of gastrointestinal bleeding is heightened in patients who are concurrently using anticoagulants or steroid medications. Additionally, individuals aged 60 years or older, those consuming three or more alcoholic beverages daily, and patients with a history of stomach ulcers or bleeding disorders are at an elevated risk. It is advised that these patients exercise caution and consult a healthcare professional prior to using this product.

Pharmacokinetic Interactions:

Patients taking other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen), should be aware that concurrent use may further increase the risk of gastrointestinal complications. It is recommended that these individuals avoid using this product alongside other NSAIDs unless directed by a healthcare provider.

Monitoring and Dosage Adjustments:

Patients are advised to seek medical advice before using this product if they are currently taking prescription medications for gout, diabetes, or arthritis. Close monitoring may be necessary in these cases to mitigate potential interactions and ensure safe use. Additionally, patients should adhere strictly to the recommended dosage and duration of use to minimize the risk of adverse effects.

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 doctor. 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 professional.

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 doctor should be consulted immediately, as these may be early signs of this rare but serious illness.

Geriatric Use

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

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

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 and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, who can assess the benefits and risks in their specific situation.

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 pregnancy 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 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 severity of the impairment.

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 evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

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

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 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 must be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should 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 feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should stop using the product and contact their healthcare provider.

Furthermore, patients should be advised 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 seek medical advice if they notice any redness or swelling, or if new symptoms arise, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Additionally, it is important to recommend that patients consult a doctor before using the product if they are taking a diuretic or any prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.

View product document (PDF)