Aspirin Low Dose Chewable Orange

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Healthcare providers may also consider other potential uses for Chewable Aspirin 81 mg based on individual patient needs.

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

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 4 to 8 tablets every 4 hours as needed. It is imperative that the total daily dosage does not exceed 48 tablets within a 24-hour period unless specifically 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 patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be administered 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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or 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 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, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician 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 with asthma or those taking diuretics should seek medical advice before use. It is also recommended that patients on prescription medications for gout, diabetes, or arthritis consult with a doctor or pharmacist prior to using this product.

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

Patients should discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, including 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, or if redness, swelling, ringing in the ears, or loss of hearing occurs, patients should seek medical attention. Any new or unusual symptoms should also prompt a consultation with a healthcare provider, as they may signify a serious condition.

Side Effects

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

Aspirin, the active ingredient in this 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be advised to stop 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.

Patients should also be cautious and consult a doctor before using this product if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, those taking diuretics or prescription medications for gout, diabetes, or arthritis should seek advice from a healthcare professional prior to use.

It is essential for patients to monitor for any new symptoms or worsening conditions, including fever lasting more than three days, redness or swelling, ringing in the ears, or loss of hearing, and to seek medical attention if these occur.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with anticoagulant medications or other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as ibuprofen and naproxen.

In patients taking aspirin, caution is advised when considering the use of medications for gout, diabetes, or arthritis. It is recommended that individuals consult with a healthcare professional prior to initiating aspirin therapy if they are currently on any of these prescription medications.

Additionally, patients with a history of gastrointestinal issues, such as heartburn, or those with conditions like high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before using aspirin. This is particularly important for those who are also taking diuretics, as these factors may influence the safety and efficacy of aspirin therapy. Monitoring and potential dosage adjustments may be necessary based on individual patient circumstances.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin Low Dose Chewable Orange (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 pediatric patients under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations. For those aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). 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.

Before initiating treatment, healthcare providers should inquire about the presence of any contraindications, including but not limited to high blood pressure, heart disease, liver cirrhosis, or kidney disease. These conditions may further elevate the risk of adverse effects associated with NSAID use in elderly patients.

Close monitoring of these patients is recommended to ensure safety and to mitigate potential complications. Adjustments to the dosage may be necessary based on the individual patient's health status and response to therapy.

Pregnancy

Use of aspirin during the last trimester of pregnancy is contraindicated unless specifically directed by a healthcare provider. Administration of aspirin in this period may pose risks to the developing fetus and can lead to complications during delivery. Healthcare professionals should counsel pregnant patients regarding these potential risks and consider alternative therapies when appropriate. It is essential to weigh the benefits against the potential fetal impacts before prescribing aspirin to women in the later stages of pregnancy.

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 its use in lactating individuals.

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 accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national Poison Control Center can be reached at 800-222-1222.

Prompt intervention is crucial in managing overdose situations to mitigate potential adverse effects and ensure patient safety.

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 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 specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 in the event of an accidental overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, specifically within the range of 15°C to 30°C.

Healthcare professionals are advised to ensure that the safety seal under the cap is intact before use; the product should not be utilized if the seal is broken or missing. Proper handling and storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. It is particularly crucial to avoid the use of aspirin during the last trimester 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 Low Dose Chewable Orange, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)