Adult Low Dose Aspirin

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, iron oxide (red), and iron oxide (yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product may not provide immediate relief for headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to inquire about additional uses of this product as deemed appropriate for individual patient needs.

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. It is imperative not to exceed a total of 48 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician 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, such patients should avoid this product.

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). 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, 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 beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use.

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

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other concerning symptoms warranting medical consultation include worsening pain lasting more than 10 days, a fever that persists beyond three days, redness or swelling in the affected area, the emergence of new symptoms, or any ringing in the ears or hearing loss. These symptoms may signify a serious underlying condition that requires prompt evaluation.

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 for these individuals to avoid this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin, a component of this product, may 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 seek medical attention 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, consume three or more alcoholic drinks daily while using this product, or take other medications containing NSAIDs (such as aspirin, ibuprofen, or naproxen). Patients should be advised to use this product only as directed and to avoid prolonged use.

Patients are instructed to stop using the product and seek medical advice if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, 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 redness or swelling occurs in the painful area, or if any new symptoms arise, patients should consult a healthcare professional. Ringing in the ears or loss of hearing should also prompt immediate medical consultation.

Before using this product, patients should consult a healthcare provider 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. Those taking diuretics or prescription medications for gout or arthritis should also seek advice from a doctor or pharmacist prior to use.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of gastrointestinal distress.

The use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further increase the risk of severe stomach bleeding when taken alongside the aforementioned medications. It is advisable to evaluate the necessity of NSAID therapy in patients receiving anticoagulants or steroids and to monitor for any gastrointestinal complications.

Patients who are prescribed medications for gout or arthritis should consult their healthcare provider to assess potential interactions and the need for dosage adjustments or additional monitoring.

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

Packaging & NDC

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

Pediatric Use

Children and teenagers who have or are 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 important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 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 of age, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing this medication to geriatric patients.

Healthcare providers should advise elderly patients to consult a physician if they have a history of stomach issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may further elevate the risk of gastrointestinal complications and warrant a thorough evaluation before initiating treatment.

Close monitoring and appropriate dose adjustments may be necessary to ensure the safety and efficacy of the medication in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 while breastfeeding.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, Reye's syndrome in children and teenagers, asthma exacerbation, renal impairment, hepatic impairment, skin reactions including rash and urticaria, as well as tinnitus and hearing loss.

Additional safety information derived from postmarketing experience indicates an increased risk of gastrointestinal bleeding in patients over 60 years of age or those with a history of ulcers or bleeding disorders. There have also been reports of severe allergic reactions, which include hives, facial swelling, and shock. Notably, cases of Reye's syndrome have been reported in children and teenagers who used aspirin during viral infections.

Patient Counseling

Healthcare providers should advise patients to keep this 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 this 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 an allergic reaction, such as difficulty breathing or swelling of the face or throat, and to seek medical assistance right away.

Patients should be made aware of the signs of potential stomach bleeding, which include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. They should be advised to discontinue use and consult a healthcare professional if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, if any new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using this medication 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. Additionally, patients taking a diuretic or those with asthma should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking a prescription drug for gout or arthritis.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a controlled environment, maintaining a temperature range of 20° to 25°C (60° to 77°F). The storage area should be dry to ensure the integrity of the product. Proper handling and storage conditions are vital to preserve the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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