Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. Each tablet contains 81 mg of aspirin, formulated as a low-dose regimen. The product is safety coated to minimize gastrointestinal irritation. It is available in a dosage form of 100 enteric-coated tablets, ensuring the active ingredient is released in the intestine rather than the stomach. The National Drug Code (NDC) for this product is 17856-3086-01.

Uses and Indications

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

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. The total daily dosage 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 recommended unless specifically directed by a physician.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use 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 Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Healthcare professionals should be vigilant for these symptoms and advise patients to seek immediate medical attention if they occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases under the following circumstances:

• If the patient takes more than the recommended dose or for an extended duration.

• If the patient is concurrently using other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen.

• If the patient has a history of stomach ulcers or bleeding disorders.

• If the patient is taking anticoagulants or steroid medications.

• If the patient is aged 60 years or older.

• If the patient consumes three or more alcoholic beverages daily while using this product.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have:

• A history of asthma.

• Conditions that may increase the risk of stomach bleeding.

• A history of gastrointestinal issues, such as heartburn.

• Ongoing treatment with diuretics.

• High blood pressure, heart disease, liver cirrhosis, or kidney disease.

Emergency Medical Help In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Discontinuation and Consultation Patients should be instructed to stop using the product and contact a healthcare provider if any of the following occur:

• Signs of an allergic reaction, which require urgent medical attention.

• Symptoms indicative of stomach bleeding, such as vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain.

• Ringing in the ears or loss of hearing.

• Worsening pain or pain that persists beyond 10 days.

• Presence of redness or swelling.

• The emergence of new symptoms, which may suggest a serious underlying condition.

Healthcare professionals should ensure that patients are fully informed of these warnings and precautions to promote safe and effective use of the product.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye's syndrome is a rare but serious illness that can 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 may indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for potential severe stomach bleeding. The risk of stomach bleeding is heightened in patients who take more than the recommended dosage or for an extended duration, those who use other medications containing NSAIDs (including aspirin, ibuprofen, or naproxen), individuals with a history of stomach ulcers or bleeding problems, and those taking blood thinners or steroid medications. Patients aged 60 or older and those consuming three or more alcoholic drinks daily while using this product are also at increased risk.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, redness or swelling, or the emergence of new symptoms, as these may signal a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription agents such as aspirin, ibuprofen, and naproxen, may elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these medications concurrently and consider monitoring for signs of gastrointestinal distress.

The concomitant use of anticoagulants or steroid medications may also heighten the risk of severe stomach bleeding. It is advisable for healthcare providers to evaluate the necessity of these combinations and to monitor patients closely for any adverse effects.

Patients taking prescription medications for conditions such as gout, diabetes, or arthritis should consult their healthcare provider to ensure safe use and to discuss potential interactions with their current treatment regimen.

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

Packaging & NDC

Below are the non-prescription pack sizes of 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, the use of this product is not recommended unless directed by a healthcare professional. In contrast, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a doctor.

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 heightened vulnerability to gastrointestinal complications.

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 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 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

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 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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 arise during the course of treatment.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. It is crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. Patients should also be made aware of the signs of potential stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing stomach pain that does not improve. They should be advised to stop use and consult a doctor if they notice any of these symptoms.

Furthermore, patients should be informed to stop use and seek medical advice if they experience ringing in the ears, a loss of hearing, worsening pain, or if pain persists for more than 10 days. They should also be advised to consult a doctor if they observe any redness or swelling, or if new symptoms arise, as these may indicate a serious condition.

Patients with asthma should be encouraged to ask their doctor before using this product. It is also important for patients to consult a doctor if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Those taking diuretics, or who have high blood pressure, heart disease, liver cirrhosis, or kidney disease, should also be advised to seek medical guidance prior to use.

Lastly, patients should be encouraged to consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis, to ensure safe and appropriate use of the product.

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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety. Special handling requirements are not specified; however, standard precautions should be taken to maintain the integrity of the product during storage.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)