Aspirin

Description

NDC 57896-901-01. GERI CARE® ASPIRIN is a nonsteroidal anti-inflammatory drug (NSAID) formulated as a regular strength pain reliever and fever reducer, containing 325 mg of aspirin per tablet. The product is packaged in a bottle containing 100 tablets. It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Bayer® Aspirin. The product features a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing. Distributed by GERI-CARE PHARMACEUTICAL CORP., located at 1295 Towbin Ave., Lakewood, NJ 08701.

Uses and Indications

This drug is indicated for the temporary relief of pain and fever associated with colds, as well as for the alleviation of headache, muscle pain, minor pain of arthritis, toothache, and menstrual pain.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. Each dose should be taken with a full glass of water to ensure proper hydration and absorption.

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. 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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include facial swelling, shock, hives, 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 60 years of age or older, those who are concurrently taking other medications containing NSAIDs (including aspirin, ibuprofen, or naproxen), individuals who consume three or more alcoholic beverages daily while using this product, those who exceed the recommended dosage or duration of use, individuals with a history of stomach ulcers or bleeding disorders, and those taking anticoagulants or steroid medications.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of asthma, if the stomach bleeding warning applies to them, or if they have a history of gastrointestinal issues such as heartburn. Additionally, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics, should seek medical advice before using this product. Patients should also consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

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

Patients are advised to discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face or throat. Additionally, they should seek medical attention if they notice any signs of stomach bleeding, including vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, feeling faint, or if they develop ringing in the ears or a loss of hearing. Other concerning symptoms that warrant medical consultation include worsening pain lasting more than 10 days, fever persisting for more than 3 days, visible redness or swelling, or the emergence of new symptoms, as these may indicate a serious underlying condition.

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 facial swelling, shock, hives, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

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 60 years of age or older, those taking other NSAIDs (either prescription or nonprescription), individuals consuming three or more alcoholic drinks daily while using the product, and patients with a history of stomach ulcers or bleeding problems. Furthermore, prolonged use or exceeding the recommended dosage, as well as concurrent use of blood thinners or steroid medications, can increase the likelihood of stomach bleeding.

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, persistent stomach pain, or feelings of faintness. Other concerning symptoms that warrant medical attention 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 indicate a serious underlying condition that requires prompt evaluation.

Drug Interactions

Aspirin may enhance the risk of gastrointestinal bleeding when co-administered with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen. This risk is further elevated in patients concurrently using anticoagulants or corticosteroids.

Additionally, caution is warranted for patients who consume three or more alcoholic beverages daily while taking aspirin, as this may also increase the likelihood of gastrointestinal complications.

No specific interactions with laboratory tests have been identified in the available data.

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 and adults 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 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 provider should be consulted, as these may be early signs of Reye's syndrome, a rare but serious condition.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 consider the potential benefits and risks when prescribing this medication to 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 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 comorbid 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 degree 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 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 be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition thoroughly and implement appropriate interventions based on clinical presentation and established protocols.

In summary, immediate medical attention is essential in cases of overdose, and healthcare professionals should be prepared to provide comprehensive care to ensure patient safety and recovery.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 other NSAIDs, individuals consuming three or more alcoholic drinks daily, patients exceeding the recommended dosage, and those with a history of stomach ulcers or bleeding problems, or who are on blood thinning (anticoagulant) or steroid medications.

Adverse reactions reported in the postmarketing experience include signs indicative of stomach bleeding, such as vomiting blood, the presence of bloody or black stools, and persistent stomach pain that does not improve. Other noted adverse reactions encompass tinnitus (ringing in the ears) or hearing loss, exacerbation of pain, 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 not to use the 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 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, experiencing persistent stomach pain, or feeling faint. 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 asthma or if the warning regarding stomach bleeding applies to them. It is also important to discuss any history of stomach problems, such as heartburn, as well as conditions like high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be advised to consult a doctor or pharmacist prior to use.

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 25ºC (77ºF). Temporary excursions from this temperature are permissible, provided they remain within the range of 15ºC to 30ºC (59ºF to 86ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

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.

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