Aspirin

Description

This product contains aspirin, a nonsteroidal anti-inflammatory drug (NSAID), formulated as safety-coated tablets. Each tablet delivers a low dose of 81 mg of aspirin, designed to provide pain relief. The safety coating is intended to minimize the risk of stomach upset associated with aspirin use. This product is comparable to the active ingredient found in Bayer® Low Dose Aspirin. It is important to consult a healthcare provider before using this product, as aspirin may not be suitable for everyone. The product is tamper-evident; do not use if the printed safety seal under the cap is broken or missing. For complete warnings and product information, retain the outer carton. This product is distributed by Publix Supermarkets, Inc., located at 3300 Publix Corporate Parkway, Lakeland, FL 33811.

Uses and Indications

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

Healthcare professionals are encouraged to inquire about additional uses for safety coated 81 mg aspirin.

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, it is advised to consult a physician for appropriate dosing recommendations.

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

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 illness.

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

Before initiating treatment, healthcare providers should inquire about the following conditions, as they may necessitate caution: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or current use of diuretics or asthma medications.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should be advised to discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction, such as hives or difficulty breathing. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include worsening pain lasting more than 10 days, fever persisting beyond three days, visible redness or swelling, ringing in the ears, loss of hearing, or the emergence of new symptoms, as these may signal a serious underlying condition.

Side Effects

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

Serious Adverse Reactions 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 doctor, as these may be early signs of Reye's syndrome.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms can include hives, shock, facial swelling, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help immediately.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to 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 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 should 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 persistent stomach pain. Additionally, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, if ringing in the ears or loss of hearing occurs, or if new symptoms develop, medical advice should be sought, as these could indicate a serious condition.

Common Adverse Reactions While specific common adverse reactions are not detailed in the provided information, patients should remain vigilant for any unexpected symptoms and report them to their healthcare provider.

Drug Interactions

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding when these medications are used together.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, or naproxen, may also increase the risk of stomach bleeding. It is advisable to assess the necessity of concurrent NSAID therapy and to monitor for gastrointestinal adverse effects.

Patients taking prescription medications for gout, diabetes, or arthritis are encouraged to consult their healthcare provider prior to using this product to ensure safe and effective use.

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, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years, consultation with a doctor is advised before 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 this medication to geriatric patients, especially if they have a history of gastrointestinal issues, such as heartburn, or comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Healthcare providers should consult with elderly patients regarding the stomach bleeding warning and assess their individual risk factors. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure timely intervention and management of any adverse effects.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, should be approached with caution. Administration of aspirin in this period may pose risks to the developing fetus and could lead to complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later 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 its use during lactation.

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 drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated carefully, as these factors may further complicate the management of hepatic impairment. It is advised that healthcare providers consider these comorbidities when determining the appropriate treatment regimen for patients with compromised liver function.

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, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks to the patient’s health.

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 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 text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, shock, facial swelling, and asthma (wheezing). Additionally, severe stomach bleeding has been noted, 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 consuming three or more alcoholic drinks daily while using this product, or those exceeding the recommended dosage.

Reports of Reye's syndrome have been documented in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Furthermore, the emergence of new symptoms during the use of this product may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients should be informed not to use the product if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is crucial to emphasize that individuals with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Patients should be instructed to stop using the product and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. Additionally, they should be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If pain persists or worsens beyond 10 days, or if fever worsens or lasts more than 3 days, patients should be advised to stop use and consult a doctor. They should also be informed to seek medical advice if they notice any redness or swelling, experience ringing in the ears, or have a loss of hearing. New symptoms should be reported to a healthcare provider, as they may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or who have asthma should also be encouraged to consult a doctor prior to use. Furthermore, patients should be advised to speak with a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light. Freezing is not permitted, as it may compromise the product's quality. Any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a health professional prior to use, particularly if they are pregnant or breastfeeding. It is crucial to inform patients that aspirin should not be used after 20 weeks of pregnancy unless specifically directed by a healthcare provider.

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)