Low Dose Aspirin

Description

The product is available in two packaging configurations: 120 tablets and 1000 tablets. Each tablet is formulated to deliver the specified active ingredient in a precise dosage, ensuring consistent therapeutic efficacy. The tablets are designed for oral administration and are manufactured under stringent quality control standards to maintain integrity and potency throughout their shelf life.

Uses and Indications

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

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

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 as needed for symptom relief. It is imperative that patients do not 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 of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• Discontinue use and consult a healthcare professional if any of the following occur: signs of stomach bleeding (e.g., feeling faint, bloody or black stools, vomiting blood, persistent stomach pain), allergic reactions, tinnitus or hearing loss, worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the affected area, or the emergence of new symptoms.

Warnings and Precautions

The use of this product necessitates careful consideration of several critical warnings and precautions to ensure patient safety.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert This product contains aspirin, which may provoke severe allergic reactions. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms occur.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood thinners (anticoagulants) or steroid medications, or other NSAIDs (including aspirin, ibuprofen, or naproxen)

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

• Exceed the recommended dosage or duration of use

Contraindications This product should not be used by individuals with a known allergy to aspirin or any other pain reliever or fever reducer.

Discontinuation of Use Patients should discontinue use and consult a healthcare provider if they experience any of the following signs indicative of potential stomach bleeding:

• Feeling faint

• Presence of bloody or black stools

• Vomiting blood

• Persistent stomach pain that does not improve

Additionally, medical advice should be sought if an allergic reaction occurs, if there is ringing in the ears or loss of hearing, if pain worsens or persists beyond 10 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed in the affected area, or if new symptoms develop.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 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.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include hives, shock, facial swelling, and 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 increase the risk of severe stomach bleeding. The risk is heightened 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 exceed the recommended dosage or duration of use.

Patients should discontinue use and consult a doctor 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, patients should seek medical advice if they notice an allergic reaction, experience ringing in the ears or loss of hearing, if pain worsens or lasts longer than 10 days, if fever worsens or lasts longer than 3 days, if redness or swelling occurs in the painful area, or if new symptoms arise.

Before using this product, patients should consult a doctor if they have asthma, if the stomach bleeding warning applies to them, 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. It is also advisable to seek medical advice if they are taking a diuretic or any prescription drugs for diabetes, gout, or arthritis, or if they are under a doctor's care for any serious condition.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together, and patients should be monitored for signs of bleeding.

The co-administration 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 gastrointestinal bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating NSAID therapy if they are already taking anticoagulants or steroids.

Patients who are on prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before starting any new medications. Additionally, individuals under medical supervision for serious health conditions or those taking multiple medications should consult their healthcare provider to ensure safe and effective treatment regimens.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a healthcare professional, as these may be early signs of this rare but serious condition.

For children under 12 years of age, it is advised to consult a doctor before use. The product should be kept out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or the Poison Control Center (1-800-222-1222) contacted, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

For adolescents aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed while symptoms persist, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Additionally, patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize the risk of adverse effects.

Pregnancy

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

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, 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

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

Overdosage of this product may lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with overdose can include nausea, vomiting, and abdominal pain.

In the event of an overdose, it is imperative to seek immediate medical attention. Additionally, contacting a Poison Control Center is strongly recommended to ensure appropriate management and intervention. Prompt action is crucial to mitigate potential harm and address any complications that may arise from the overdosage.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed to discontinue use and consult a doctor 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, they should seek immediate medical assistance if they notice an allergic reaction, experience ringing in the ears or loss of hearing, if pain worsens or lasts longer than 10 days, if fever persists or worsens beyond 3 days, if there is redness or swelling in the painful area, or if new symptoms arise, as these could indicate a serious condition.

It is important for patients to consult a doctor before using the medication if they have asthma or if the warning regarding stomach bleeding applies to them. Patients with a history of stomach problems, such as heartburn, should also seek medical advice prior to use. Furthermore, those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should discuss their conditions with a healthcare provider before taking the medication.

Patients taking diuretics, prescription drugs for diabetes, gout, or arthritis, or those under a doctor's care for any serious condition should consult a doctor or pharmacist before use. Lastly, patients should be encouraged to discuss any other medications they are taking with their healthcare provider or pharmacist to ensure safe use of the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, within the range of 15º to 30º C (59º to 86º F), to maintain its efficacy and safety.

Healthcare professionals should ensure that the product is not used if the imprinted safety seal under the cap is broken or missing, as this may indicate potential tampering or contamination. Proper handling and storage conditions are vital to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, consultation with a doctor is advised before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a healthcare provider, 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 Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)