Aspirin

Description

This product is identified by NDC 79481-6450-5 and contains 81 mg of aspirin as the active ingredient, functioning as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief. It is formulated as safety-coated tablets, designed for an aspirin regimen. The product is tamper evident; it should not be used if the imprinted safety seal under the cap is broken or missing. It is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544. This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the owner of the registered trademark St. Joseph® Low Dose Aspirin. For more information, visit www.meijer.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

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.

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 specifically directed by a healthcare professional.

It is essential for patients to consume a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness.

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

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. This precaution is necessary to prevent potential severe allergic reactions.

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, 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 taking anticoagulants or steroid medications.

• Are aged 60 years or older.

• Use the product in higher doses or for extended periods beyond the recommended guidelines.

• Are concurrently using other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

• Have a history of stomach ulcers or bleeding disorders.

• Consume three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply:

• The patient has a history of stomach problems, including heartburn.

• The patient has high blood pressure, heart disease, liver cirrhosis, or kidney disease.

• The patient is taking diuretics.

• The patient has asthma.

Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

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

Patients are advised to discontinue use and contact a healthcare provider if they experience any of the following:

• Signs of an allergic reaction, which require urgent medical attention.

• Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain.

• Ringing in the ears or loss of hearing.

• Worsening pain that lasts longer than 10 days.

• A fever that worsens or persists beyond 3 days.

• Redness or swelling at the site of use.

• The emergence of any new symptoms.

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 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 may be early signs of Reye's syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, shock, or asthma (wheezing). Patients should seek immediate medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are taking blood thinners or steroid medications, are aged 60 or older, exceed the recommended dosage or duration of use, consume other NSAIDs (including aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding problems, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to stop use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other symptoms warranting medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the appearance of any new symptoms.

Before using this product, patients should consult a doctor if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to seek medical advice if they are taking diuretics or have asthma. Furthermore, patients should inform their doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question, and patients should be closely monitored for any signs of gastrointestinal distress.

Additionally, it is advisable for patients to consult with a healthcare provider or pharmacist prior to initiating therapy if they are currently taking prescription medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use of the drug, as potential interactions may necessitate dosage adjustments or enhanced monitoring.

Packaging & NDC

Below are the non-prescription pack sizes of 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, the product should not be used unless directed by a doctor. For those aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal complications.

Healthcare providers should closely monitor geriatric patients for signs of gastrointestinal bleeding and consider appropriate dose adjustments or alternative therapies as necessary. It is essential to weigh the benefits and risks of treatment in this population, ensuring that safety measures are in place to mitigate potential adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the benefits and risks of aspirin use in this population to ensure maternal and fetal safety.

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 its use 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 renal 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 to assess liver function and consider potential risks associated with the use of this medication in individuals with compromised liver function. Monitoring of liver parameters may be warranted to ensure safety and efficacy in this patient population. Adjustments to dosage or treatment regimens may be necessary based on the severity of hepatic impairment, and healthcare providers should evaluate the overall health status of patients with high blood pressure, heart disease, or kidney disease in conjunction with liver function considerations.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation.

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 revealed that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma (wheezing). Additionally, there have been indications that aspirin may cause severe stomach bleeding, particularly in individuals who exceed the recommended dosage, are concurrently using blood-thinning (anticoagulant) or steroid medications, consume three or more alcoholic beverages daily while using this product, are aged 60 years or older, have a history of stomach ulcers or bleeding issues, or are taking other medications containing prescription or nonprescription NSAIDs (such as aspirin, ibuprofen, or naproxen).

Reports of serious adverse reactions have included symptoms indicative of stomach bleeding, such as bloody or black stools, feelings of faintness, vomiting blood, and persistent stomach pain. Other adverse reactions reported include tinnitus (ringing in the ears) or hearing loss, exacerbation of pain lasting more than 10 days, fever that worsens or persists for more than 3 days, redness or swelling, and the emergence of new symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, which requires prompt medical attention. Additionally, they should be made aware of the symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should also report any occurrence of ringing in the ears or loss of hearing, worsening pain that lasts more than 10 days, a fever that worsens or lasts more than 3 days, any redness or swelling, or the emergence of new symptoms.

It is important for healthcare providers to recommend that patients consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be encouraged to seek medical advice prior to use. Furthermore, those taking diuretics or who have asthma should discuss their conditions with a healthcare professional before starting the medication.

Patients should be advised to consult a doctor or pharmacist before use if they are currently taking prescription medications for diabetes, gout, or arthritis to ensure safe and effective use.

Storage and Handling

The product is supplied in configurations that include 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 to ensure proper tracking and usage.

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)