Physicians Care Aspirin

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, minor arthritis pain, pain and fever associated with colds, backache, menstrual cramps, toothache, and muscle aches.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients should drink a full glass of water with each dose to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is as follows: take 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional immediately, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, shock, and asthma (wheezing). Should an allergic reaction occur, the patient must discontinue use and seek immediate medical assistance.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk is heightened in individuals who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen)

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

• Exceed the recommended dosage or duration of use

Monitoring for Stomach Bleeding Patients should be instructed to stop use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if there is ringing in the ears or loss of hearing, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical advice should be sought.

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

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. 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, a component of this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). If an allergic reaction occurs, patients are advised to discontinue use and seek medical assistance promptly.

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, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients should stop using the product 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. Additionally, if pain worsens or lasts longer than 10 days, if fever worsens or lasts more than 3 days, if there is ringing in the ears or loss of hearing, if redness or swelling occurs in the painful area, or if any new symptoms arise, medical advice should be sought.

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

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Physicians Care Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a doctor before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms 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, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome.

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.

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). It is crucial for healthcare providers to assess the individual risk factors for each geriatric patient prior to prescribing this medication.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of gastrointestinal complications, such as a history of stomach bleeding, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Given the potential for adverse effects, careful monitoring and consideration of dose adjustments may be warranted in this population to ensure safety and efficacy.

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 gestation 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 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 the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

It is crucial to document any instances of overdose and report them to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically 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

No specific postmarketing experience details are available in the extracted 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 keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is essential to counsel patients to stop using the medication 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 stomach pain that does not improve.

Patients should be made aware that if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days, they should seek medical advice. Additionally, they should be informed to report any occurrence of ringing in the ears or loss of hearing, as well as any redness or swelling in the painful area, or the appearance of any new symptoms.

In the case of an allergic reaction, patients should be instructed to seek medical help immediately. Healthcare providers should also recommend that patients consult a doctor before use if they have a history of stomach bleeding, asthma, or stomach problems such as heartburn. Furthermore, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to discuss their conditions with a healthcare provider prior to using the medication.

Lastly, patients taking a diuretic or prescription medications for gout, diabetes, or arthritis should be encouraged to consult a doctor or pharmacist before using this medication to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat and humidity to maintain its integrity.

Care should be taken to avoid using any opened or torn packets, as this may compromise the product's quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's intended use and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Physicians Care Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)