Aspi-Cor

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, 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 hydration and facilitate absorption.

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

Patients are cautioned against exceeding the recommended dosage to avoid potential adverse effects.

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. 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 illness.

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 increases in individuals who are 60 years of age or older, take higher doses or use the product for an extended duration, are concurrently using blood thinners (anticoagulants) or steroid medications, have a history of stomach ulcers or bleeding disorders, consume three or more alcoholic beverages daily while using this product, or are taking other medications that contain NSAIDs, such as 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; high blood pressure; heart disease; liver cirrhosis; kidney disease; asthma; or if they are taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently prescribed medications for gout, diabetes, or arthritis.

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

Patients are advised to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives 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, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or loss of hearing, the emergence of new symptoms, worsening pain lasting more than 10 days, fever that intensifies or persists beyond three days, or the presence of redness or swelling, as these may signal a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious and common 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 chicken pox 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.

Aspirin may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should stop using the product and seek medical assistance right away.

Additionally, 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 who take more of the product or for a longer duration than directed, individuals on blood-thinning (anticoagulant) or steroid medications, patients with a history of stomach ulcers or bleeding problems, those consuming three or more alcoholic drinks daily while using the product, and individuals taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

Patients should 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 attention include ringing in the ears, loss of hearing, the emergence of new symptoms, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, or the presence of redness or swelling. These symptoms could indicate a serious condition requiring prompt medical evaluation.

Drug Interactions

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe gastrointestinal bleeding. This risk is particularly heightened in patients who are concurrently using anticoagulants or steroid medications. Additionally, the concomitant use of other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen), may further elevate this risk.

Patients should exercise caution and consult with a healthcare professional prior to using this product if they are currently prescribed medications for gout, diabetes, or arthritis. Monitoring for potential adverse effects is advised in these cases, and dosage adjustments may be necessary based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Aspi-Cor (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, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For children under 12 years of age, the product should not be used unless directed by a doctor. It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought or a Poison Control Center should be contacted.

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 doctor.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). The risk of gastrointestinal complications is heightened in this population, especially for those who take higher doses or use the medication for an extended duration beyond the recommended guidelines.

Additional factors that may further elevate the risk of stomach bleeding include concurrent use of anticoagulants or steroid medications, a history of stomach ulcers or bleeding disorders, and the consumption of three or more alcoholic drinks daily while using this product. Furthermore, elderly patients should be cautious if they are taking other medications that contain NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should closely monitor geriatric patients for any signs of gastrointestinal distress and consider appropriate dose modifications or alternative therapies to mitigate these risks.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later unless specifically 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 potential benefits and risks when considering the use of this medication in pregnant patients.

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 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 specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations 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 relevant information regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology was extracted.

Postmarketing Experience

No specific postmarketing experience details have been reported. 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 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 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 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, new symptoms, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. Redness or swelling should also prompt a consultation with a doctor, as these may indicate a serious condition.

Healthcare providers should encourage patients to ask 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to consult a doctor prior to use. Additionally, those with asthma or who are taking a diuretic should seek medical advice before using the product. Lastly, patients taking prescription medications for gout, diabetes, or arthritis should be encouraged to consult with a doctor or pharmacist before use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspi-Cor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)