First Aid Direct Chewable Aspirin

Description

Each chewable tablet contains Aspirin 81 mg, classified as a nonsteroidal anti-inflammatory drug (NSAID).

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 consider additional uses for the 81 mg chewable aspirin formulation based on individual patient needs.

Limitations of Use: There are no known 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 as needed. It is imperative not to exceed a total of 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, 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

Use of this product is associated with several important warnings and precautions that healthcare professionals should be aware of to ensure patient safety.

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 physician, 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, asthma (wheezing), or shock. Healthcare providers should monitor patients for these symptoms and advise them to seek immediate medical attention if they occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which poses a risk of severe stomach bleeding. The likelihood of this adverse effect increases in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood-thinning medications (anticoagulants) or steroid drugs

• Are taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Stop Use and Consult a Doctor Patients should discontinue use and seek medical advice if they experience an allergic reaction, or if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or with a history of asthma should consult a healthcare provider before use.

Emergency Medical Help In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately. Prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

No specific laboratory tests are indicated for monitoring the use of this product; however, healthcare professionals should remain vigilant for the aforementioned warnings and precautions to ensure patient safety.

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 carries a significant allergy alert. Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

The product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened 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 while using the 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 allergic reactions or if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or with a history of asthma should also seek medical advice before using this product.

It is recommended that patients ask a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of First Aid Direct Chewable Aspirin (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 any changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a doctor. For children under 12 years, consultation with a doctor is required before use.

It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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 medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of stomach bleeding, such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. A thorough assessment of the patient's medical history and current health status is crucial to ensure safe and effective use of the medication in geriatric patients.

Monitoring for signs of gastrointestinal bleeding is recommended in elderly patients, especially those with pre-existing risk factors. Adjustments to dosage or alternative therapeutic options may be necessary based on individual patient assessments.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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. Healthcare providers should carefully evaluate the risks and benefits before recommending aspirin to pregnant patients, especially 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any signs or symptoms that may arise. Common symptoms of overdosage can vary widely depending on the medication involved and may include, but are not limited to, neurological disturbances, gastrointestinal symptoms, or cardiovascular effects.

Management of an overdosage situation should involve immediate supportive care. Healthcare professionals are advised to monitor the patient's vital signs closely and provide symptomatic treatment as necessary. In cases where the specific antidote or treatment protocol is known, it should be administered promptly.

It is crucial to consult local poison control centers or relevant medical authorities for guidance on the management of overdosage cases, as they can provide tailored recommendations based on the specific circumstances and the medication involved.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically 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 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 on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, regardless of whether they observe any signs or symptoms. It is crucial for both adults and children to receive prompt medical attention in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its efficacy. Additionally, it is imperative to keep the product out of reach of children to ensure safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for First Aid Direct Chewable Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)