Aspirin

Description

Aspirin, with an NDC of 56062-118-11, is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief and fever reduction. Each coated tablet contains 325 mg of aspirin, classified as regular strength. The product is packaged in a bottle containing 100 coated tablets, designed for ease of administration. The actual size of the tablets is consistent with standard formulations. This product is comparable to the active ingredient found in Genuine Bayer® Aspirin.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain, including headache, muscle pain, toothache, menstrual pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever related to colds.

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 to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 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

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

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event is increased 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 (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Individuals should refrain from using this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or asthma. Additionally, consultation with a doctor or pharmacist is recommended for those taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), worsening pain lasting more than 10 days, presence of redness or swelling, fever that worsens or lasts more than three days, emergence of new symptoms, or experiences of ringing in the ears or hearing loss. These symptoms may signify a serious medical condition requiring prompt attention.

Side Effects

Patients using this product should be aware of several serious adverse reactions 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.

Additionally, the product may cause severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to 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 stomach pain that does not improve. Other reasons to seek medical attention include worsening pain that lasts longer than 10 days, the presence of redness or swelling, a fever that worsens or lasts more than three days, the emergence of new symptoms, or any ringing in the ears or loss of hearing. These symptoms could indicate a serious condition requiring immediate medical evaluation.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both aspirin and these drug classes can increase the risk of bleeding.

Patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare professional prior to using aspirin. This recommendation is crucial to ensure safe use and to evaluate any potential interactions that may affect the management of their underlying conditions. Monitoring may be necessary to assess for adverse effects or altered therapeutic efficacy when these medications are used concurrently with aspirin.

Packaging & NDC

Below are the non-prescription pack sizes of 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 due to the risk of Reye's syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years, it is essential to consult a doctor for appropriate dosing recommendations.

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 treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. Aspirin use 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 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 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 while breastfeeding.

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 underlying conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe 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. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop as a result of the overdose.

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 revealed reports of various adverse reactions, including hives, facial swelling, asthma (wheezing), and shock. Additionally, there have been reports of severe stomach bleeding associated with the use of this product. This risk appears to be particularly pronounced in patients who are 60 years of age or older, those with a history of stomach ulcers or bleeding problems, individuals taking blood-thinning (anticoagulant) or steroid medications, patients using other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), and those who consume three or more alcoholic drinks daily while using this product. Furthermore, prolonged use or exceeding the recommended dosage may also contribute to this risk.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be cautioned against using this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important for healthcare providers to inform 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. Immediate medical attention should be sought if any of the following symptoms occur, as they may indicate stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be advised to seek medical advice if their pain worsens or persists for more than 10 days, if redness or swelling is present, if fever worsens or lasts for more than 3 days, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to consult with 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 seek medical advice prior to use. Additionally, those taking diuretics or who have asthma should be advised to consult a healthcare professional before starting the medication.

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

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product information.

Additional Clinical Information

The route of administration for the medication is oral. 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 three months 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)