Aspirin 81

Description

Good Neighbor Pharmacy Low Dose Aspirin contains 81 mg of aspirin as its active ingredient and is classified as a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief. The formulation is enteric coated to enhance gastrointestinal tolerance. Each package contains 180 tablets, with each tablet delivering 81 mg of aspirin. The National Drug Code (NDC) for this product is 46122-598-48.

The product features a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing. This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, which owns the registered trademark St. Joseph® Low Dose Aspirin. It is distributed by AmerisourceBergen, located at 1 West First Avenue, Conshohocken, PA 19428. For questions or concerns, further information can be found at www.mygnp.com.

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 not exceed the directed amount. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily intake must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. This is due to the potential for cross-reactivity and severe allergic responses.

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 condition.

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

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical advice if they notice ringing in the ears, a loss of hearing, worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, any redness or swelling, or the emergence of new symptoms.

In the event of an overdose, it is crucial to seek 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. Patients should not use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help immediately.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction increases in patients who are taking blood thinners or steroid medications, are aged 60 or older, exceed the recommended dosage or duration of use, consume other NSAIDs (including aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding problems, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to stop use 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 patients notice ringing in the ears, a loss of hearing, worsening pain lasting more than 10 days, a fever that worsens or lasts more than three days, redness or swelling, or any new symptoms, they should seek medical advice.

Before using this product, patients should consult a healthcare professional 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 important to discuss use with a doctor if the patient is taking a diuretic or has asthma. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs) significantly increases the risk of severe gastrointestinal bleeding. This risk is particularly pronounced when combining the subject drug with other NSAIDs, including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen.

Additionally, the concomitant administration of anticoagulants or steroid medications further elevates the likelihood of severe stomach bleeding. Healthcare professionals should exercise caution and consider alternative therapies or enhanced monitoring for patients receiving these combinations.

Patients prescribed medications for gout, diabetes, or arthritis should consult their healthcare provider prior to initiating treatment with the subject drug. This consultation is essential to evaluate potential interactions and to determine appropriate management strategies.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 (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. For children under 12 years of age, use is not recommended unless directed by a doctor.

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 healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 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 ratio 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. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider to mitigate these risks.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a healthcare provider, 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 in lactating individuals.

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 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 remain aware of the general signs of overdose, which may include but are not limited to altered mental status, respiratory distress, or cardiovascular instability.

Management of an overdose should be guided by the severity of symptoms and the specific circumstances surrounding the incident. Supportive care and symptomatic treatment are fundamental components of the management strategy. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions are implemented as needed.

In summary, immediate medical consultation and intervention are critical in the case of an overdose, with a focus on supportive care and monitoring for any emerging symptoms.

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 is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

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 medication if they have a history of allergic reactions to any other pain reliever or fever reducer.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. They should also be made aware of the symptoms indicative of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should be cautioned to seek medical attention if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, a fever that worsens or lasts more than 3 days, any redness or swelling, or the emergence of new symptoms.

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 the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, those taking diuretics or who have asthma should be encouraged to discuss their conditions with a healthcare professional before starting the medication.

Lastly, patients should be reminded to consult a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis, as these may interact with the medication.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage. Special handling requirements are not specified; however, adherence to the recommended storage conditions is essential for maintaining product integrity.

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 critical 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 81, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)