Aspirin 50 Ct

Description

Aspirin, identified as Product #1112, is a nonsteroidal anti-inflammatory drug (NSAID) utilized for the temporary relief of pain and fever. It is effective in alleviating muscle aches and minor arthritis pain. The formulation is designed for workplace use, adhering to ANSI Z308.1-2015 standards. Each tablet is packaged in tamper-evident packets, ensuring safety and convenience. The product is available in a package containing 50 tablets, with 2 tablets per packet. It is manufactured for American Safety & First Aid, located in Osceola, IN 46561.

Uses and Indications

This drug is indicated for the temporary relief of fever and minor aches and pains associated with various conditions, including headache, colds, muscular aches, toothache, minor arthritis pain, and menstrual cramps.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 2 tablets with water every 4 hours as needed. The total dosage should not exceed 12 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to aspirin should not use this product due to the risk of severe allergic reactions. Concurrent use with any other pain reliever or fever reducer is contraindicated, as it may increase the risk of adverse effects. Additionally, individuals who have previously experienced an allergic reaction to any pain reliever or fever reducer should avoid this product.

The product should not be used for pain lasting more than 10 days or for fever persisting beyond 3 days unless directed by a healthcare professional, as prolonged use may mask underlying conditions or lead to complications.

Warnings and Precautions

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

Aspirin, a component of this product, has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs in patients.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The risk is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to seek medical advice prior to use if any of the following conditions apply: a history of stomach bleeding, previous stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are currently taking a diuretic.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and consult a physician if they experience any signs indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, redness or swelling in the affected area, or the emergence of any new symptoms.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's Syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chicken pox 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 may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), 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 (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Patients should discontinue use and seek medical advice 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. Additionally, if pain persists or worsens beyond 10 days, or if fever worsens or lasts more than 3 days, medical consultation is advised. New symptoms, redness, or swelling in the painful area should also prompt a discussion with a healthcare provider.

Other adverse reactions that may occur include ringing in the ears or loss of hearing. Patients should be vigilant for any new symptoms or worsening of existing symptoms while using this product.

Drug Interactions

Aspirin has notable interactions with various classes of medications, particularly those affecting hemostasis and gastrointestinal integrity.

Anticoagulants Aspirin may significantly increase the risk of severe gastrointestinal bleeding when used concurrently with anticoagulant medications. It is advised that patients consult a healthcare professional before using aspirin if they are currently prescribed any anticoagulant therapy. Close monitoring for signs of bleeding is recommended.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of aspirin with other NSAIDs, including ibuprofen and naproxen, is contraindicated due to an elevated risk of stomach bleeding. Patients should avoid using aspirin alongside any other pain relievers or fever reducers that contain NSAIDs to mitigate this risk.

In summary, careful consideration and consultation with a healthcare provider are essential when aspirin is used in conjunction with anticoagulants or other NSAIDs to ensure patient safety and minimize adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 50 Ct (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to monitor for any changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye's Syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are advised to take 2 tablets with water every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of stomach bleeding, such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. In such cases, it is advisable for patients to consult with their healthcare provider prior to use to ensure appropriate management and monitoring.

Close observation and potential dosage adjustments may be warranted in geriatric patients to mitigate the risk of adverse effects associated with stomach bleeding.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully consider the potential fetal impacts and weigh the benefits against the risks when advising pregnant patients.

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 in lactating mothers.

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 may experience altered pharmacokinetics of the medication. It is essential to assess liver function prior to initiating treatment. In patients with liver cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment period to ensure safety and efficacy. Special caution should be exercised in patients with significant hepatic impairment, as they may be at increased risk for adverse effects.

Patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated carefully, as these comorbidities may further complicate the management of their hepatic condition.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

It is especially important to avoid the use of 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 related to nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Severe stomach bleeding has been observed, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily, or those exceeding the recommended dose or duration of use.

Additionally, reports of Reye's Syndrome have been noted in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Instances of ringing in the ears or loss of hearing have also been documented. Furthermore, new symptoms occurring during the use of the product have been reported.

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, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed to discontinue 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 stomach pain that does not improve. Additionally, they should seek medical advice if pain worsens or persists for more than 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs in the painful area, or if any new symptoms arise.

It is important to remind patients not to exceed the recommended dose while using this product. Healthcare providers should also encourage patients to consult a doctor before use 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 seek medical advice prior to use, as should those taking diuretics.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for anticoagulation, diabetes, gout, or arthritis to avoid potential interactions.

Storage and Handling

The product is supplied in packets that must not be used if opened or torn. It should be stored at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets with water every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended before administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, 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 50 Ct, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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