Aspirin

Description

EQUAL INE® contains low dose aspirin at a strength of 81 mg per tablet. This formulation serves as a nonsteroidal anti-inflammatory drug (NSAID) and is designed with a safety coating for enhanced gastrointestinal tolerance. The product is packaged in a bottle containing 120 enteric coated tablets.

EQUAL INE® is distributed by UNFI, located in Providence, RI 02908, USA. The National Drug Code (NDC) for this product is 41163-945-32. It is important to note that the product is tamper evident; it should not be used if the imprinted safety seal under the cap is broken or missing.

This product is comparable to St. Joseph® Low Dose Aspirin; however, it is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the owner of the registered trademark St. Joseph® Low Dose Aspirin. For customer inquiries, a service number is available at 855-423-2630.

Uses and Indications

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

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

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

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer.

Warnings and Precautions

The use of this product necessitates careful consideration of several warnings and precautions to ensure patient safety.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Immediate medical attention should be sought if any of these symptoms occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases under the following circumstances:

• Concurrent use of blood thinners (anticoagulants) or steroid medications.

• Patients aged 60 years or older.

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

• A history of stomach ulcers or bleeding disorders.

• Exceeding the recommended dosage or duration of use.

• Concurrent use of other medications containing NSAIDs, including aspirin, ibuprofen, or naproxen.

General Precautions 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, or kidney disease.

• Use of diuretics.

• A history of asthma.

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

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center.

Discontinuation and Consultation Patients should discontinue use and contact a healthcare provider if any of the following occur:

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

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

• Ringing in the ears or loss of hearing.

• Worsening pain that persists beyond 10 days.

• Fever that worsens or lasts more than 3 days.

• Presence of redness or swelling.

• Emergence of any new symptoms.

These precautions are essential for the safe use of this product and should be communicated clearly to patients.

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 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, consume three or more alcoholic drinks daily while using the product, have a history of stomach ulcers or bleeding problems, exceed the recommended dosage, or use other medications containing NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, 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 lasting more than 3 days, redness or swelling, or the emergence of any new symptoms.

Before using this product, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also important for patients taking diuretics or those with asthma to consult a doctor prior to use. Furthermore, patients should inform their healthcare provider if they are taking prescription medications for gout, diabetes, 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, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, the use of this product is not recommended unless directed by a healthcare professional. In contrast, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a doctor.

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 prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse fetal outcomes or complications during delivery if not prescribed by a physician. Therefore, it is crucial for women of childbearing potential to seek medical advice before initiating treatment with this medication.

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 conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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 current information.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 medication if they have a history of allergic reactions to any other pain reliever or fever reducer.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. They should also be made aware of the signs of stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Additionally, patients should be informed to seek medical attention if they notice ringing in the ears, a 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 appearance of new symptoms.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor 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 advised to seek medical guidance prior to use. Furthermore, those taking diuretics or who have asthma should be encouraged to discuss their conditions with a healthcare professional.

Lastly, patients should be reminded to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° 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 medication is administered orally. For adults and children 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 physician. For children under 12 years, use is not recommended unless directed by a healthcare provider.

Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product, particularly for heart-related concerns. No additional 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)