Aspirin

Description

Equate™ is a nonsteroidal anti-inflammatory drug (NSAID) classified as a pain reliever and fever reducer. Each coated tablet contains 325 mg of aspirin as the active ingredient. The product is packaged in a bottle containing 100 coated tablets. It is distributed by Walmart Inc., located in Bentonville, AR 72716. A tamper evident warning is included, stating: "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING." This product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Genuine Bayer® Aspirin. The National Drug Code (NDC) for this product is 49035-157-12.

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 and not exceed the directed amount. 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 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.

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-related 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 consuming three or more alcoholic beverages daily while using this product, and patients with a history of stomach ulcers or bleeding disorders. Additionally, the risk is heightened if the product is used in excess of the recommended dosage or duration, or if it is taken concurrently with other NSAIDs, including aspirin, ibuprofen, or naproxen.

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, concurrent use of diuretics, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients taking prescription medications for gout, diabetes, or arthritis should also 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 a healthcare professional if they experience any signs of an allergic reaction, such as difficulty breathing or swelling. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that persists or worsens beyond three days, visible redness or swelling, or the emergence of new symptoms, as these may signal a serious underlying 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. It is crucial that these individuals do not use this product. 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.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include facial swelling, shock, hives, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

Additionally, 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 who are 60 years of age or older, those taking blood-thinning (anticoagulant) or steroid medications, individuals consuming three or more alcoholic drinks daily while using this product, and patients with a history of stomach ulcers or bleeding problems. Furthermore, the risk increases if the product is taken in higher doses or for longer durations than directed, or if other medications containing prescription or nonprescription NSAIDs (such as aspirin, ibuprofen, or naproxen) are concurrently used.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant 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 emergence of new symptoms. These could signify a serious condition requiring immediate medical attention.

Drug Interactions

Aspirin has several notable interactions that may impact its safety and efficacy, particularly when used in conjunction with other medications.

Anticoagulants and Steroids Aspirin may increase the risk of severe gastrointestinal bleeding when taken with anticoagulants or steroid medications. It is advisable for patients to consult their healthcare provider before combining these therapies.

Diuretics Patients taking diuretics should seek medical advice prior to using aspirin, as there may be potential interactions that could affect treatment outcomes.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin should not be co-administered with other NSAIDs, whether prescription or over-the-counter, such as ibuprofen or naproxen. This combination may elevate the risk of adverse effects, particularly gastrointestinal complications.

Pre-existing Conditions Individuals with a history of gastrointestinal issues, such as heartburn, are encouraged to consult a healthcare professional before initiating aspirin therapy. Additionally, caution is advised for patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease when considering the use of aspirin. Monitoring and potential dosage adjustments may be necessary in these populations to mitigate risks.

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 and older, are at an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

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 benefits and risks of treatment in geriatric patients is crucial to ensure their safety and well-being.

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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 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 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 aware that the symptoms of overdose may vary depending on the specific 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 consuming three or more alcoholic drinks daily, patients with a history of stomach ulcers or bleeding problems, and those exceeding the recommended dosage.

Adverse reactions reported in the postmarketing experience include signs indicative of stomach bleeding, such as vomiting blood, the presence of bloody or black stools, feelings of faintness, and persistent stomach pain. Other noted adverse reactions encompass tinnitus or hearing loss, exacerbation of pain or fever, the appearance of 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. 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, feeling faint, or experiencing persistent stomach pain. 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. It is also important to advise patients to seek medical guidance if they are taking a diuretic, have asthma, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Lastly, patients should be reminded to consult a doctor or pharmacist before use if they are currently taking prescription medications for gout, diabetes, or arthritis.

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 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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)