Aspirin

Description

This formulation consists of low dose chewable aspirin, providing 81 mg of the active ingredient, which serves as a nonsteroidal anti-inflammatory drug (NSAID) for pain relief. The tablets are orange flavored and are packaged in a bottle containing 36 tablets. This product is comparable to the active ingredient found in Bayer® Chewable Low Dose Aspirin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

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

Dosage and Administration

Patients should take each dose 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 chewable 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 doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

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, facial swelling, asthma (wheezing), and shock. 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 problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a doctor prior to using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever persists or worsens beyond three days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical attention promptly.

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 stop using the product and seek medical assistance right away.

The 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 the 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 stomach pain that does not improve. Additional symptoms warranting medical attention include worsening pain lasting more than 10 days, fever that worsens or persists for more than three days, the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing. These symptoms could indicate a serious condition requiring prompt medical evaluation.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience increased risks of adverse effects when combined with this drug. It is advisable to monitor for signs of bleeding or other complications and to consider dosage adjustments as necessary.

The concomitant use of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may elevate the risk of gastrointestinal irritation or bleeding. Close monitoring for gastrointestinal symptoms is recommended, and dosage adjustments may be warranted based on the clinical scenario.

Additionally, patients who are on diuretics should be monitored closely, as the interaction may affect fluid and electrolyte balance. Adjustments to the diuretic dosage may be necessary depending on the patient's clinical status and response to treatment.

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

Pediatric patients, particularly those under 12 years of age, should consult a doctor before using this product. For children and teenagers who have or are recovering from chicken pox or flu-like symptoms, the use of this product is contraindicated due to the risk of Reye’s syndrome, a rare but serious illness.

In patients aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional. 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, necessitating immediate consultation with a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding when using this medication. This risk is further heightened in individuals with a history of stomach ulcers or bleeding disorders, those who are concurrently taking anticoagulants or steroid medications, and patients using other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, or naproxen.

Additionally, the risk of gastrointestinal complications may be exacerbated by the consumption of three or more alcoholic drinks daily while using this product. It is essential for healthcare providers to monitor geriatric patients closely for any signs of gastrointestinal bleeding and to consider appropriate dose modifications or alternative therapies when necessary.

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 the unborn child or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of gestation 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.

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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

Aspirin use during pregnancy, particularly after 20 weeks, should be approached with caution. It is advised that aspirin not be administered during this period unless explicitly directed by a healthcare professional, as it may pose risks to the developing fetus and could lead to complications during delivery.

No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be instructed not to use the medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. They must be made aware that they should stop using the medication and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases.

Healthcare providers should emphasize the importance of stopping the medication and contacting a doctor if patients notice 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. Patients should also be advised to seek medical attention if pain worsens or lasts longer than 10 days, if fever intensifies or persists for more than 3 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing, as these could indicate a serious condition.

Providers should encourage patients to consult with a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Additionally, patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be advised to seek medical guidance prior to use. Those taking diuretics or who have asthma should also be encouraged to consult a healthcare professional before using the medication. Finally, patients should be reminded 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 68-77°F (20-25°C) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 4 to 8 chewable tablets orally every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients regarding the use of the medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin use after 20 weeks of pregnancy unless specifically directed by a healthcare provider, 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)