Chewable Aspirin

Description

This product is manufactured in the United States and is distributed by Genuine First Aid, located at 600 Cleveland Street, Suite 400, Clearwater, FL 33755.

Uses and Indications

This drug is indicated for the temporary relief of minor aches, pains, and headaches. It is also indicated for the reduction of fever associated with colds, sore throats, and teething.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 4 to 8 tablets with water every 4 hours. The maximum dosage should 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 recommended to consult a doctor prior to administration.

The route of administration is oral, utilizing chewable tablets. It is essential that the tablets are chewed thoroughly and taken with water to ensure proper absorption and efficacy.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain relievers or fever reducers.

Additionally, the product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. It is also contraindicated for use within 7 days following a tonsillectomy or oral surgery due to the risk of complications.

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.

This product contains a non-steroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of experiencing stomach bleeding is increased in individuals who have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), exceed the recommended dosage or duration of use, are aged 60 years or older, or consume three or more alcoholic beverages while using this product.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: an allergic reaction, persistent pain or fever, the emergence of new or unexpected symptoms, signs of redness or swelling, or symptoms such as ringing in the ears or loss of hearing.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of several serious and common 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. It is crucial for these individuals to avoid using this product. 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.

The product contains a non-steroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of experiencing this adverse reaction is increased in patients who have a history of stomach ulcers or bleeding problems, those taking blood-thinning medications or steroids, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), those who exceed the recommended dosage or duration of use, patients aged 60 or older, and those consuming three or more alcoholic drinks while using the product.

Patients should discontinue use and seek medical attention if they experience an allergic reaction, persistent pain or fever, new or unexpected symptoms, redness or swelling, or symptoms such as ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have a history of asthma, ongoing stomach issues (such as heartburn, upset stomach, or stomach pain), ulcers or bleeding problems, if they are a child experiencing arthritis pain, if they are allergic to aspirin, or if they are taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Drug Interactions

The product contains a non-steroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of gastrointestinal bleeding. This risk is particularly heightened in patients who are concurrently using anticoagulants or steroid medications. Additionally, the concomitant use of other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen, may further elevate this risk.

Patients are advised to consult a healthcare professional prior to using this product if they are currently taking any prescription medications for anticoagulation, diabetes, gout, or arthritis. Monitoring for potential adverse effects is recommended in these cases to ensure patient safety and effective management of their conditions.

Packaging & NDC

Below are the non-prescription pack sizes of 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. Healthcare professionals should advise parents and caregivers to monitor for changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, it is recommended to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding when using this medication. Therefore, caution is advised when prescribing to this population.

For adults and children aged 12 years and older, the recommended dosage is to chew 4 to 8 tablets with water every 4 hours, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Healthcare providers should closely monitor geriatric patients for any signs of gastrointestinal bleeding and consider individual patient factors when determining the appropriate dosage and treatment duration.

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 pose risks to the unborn child and lead to 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 before 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with an overdose may include nausea, vomiting, and abdominal pain.

In the event of an overdose, it is imperative to seek immediate medical attention. Additionally, contacting a Poison Control Center is strongly recommended to ensure appropriate management and intervention. Prompt action is crucial to mitigate potential harm and provide the necessary care for affected individuals.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with aspirin use. Reports include allergic reactions, such as anaphylaxis, and gastrointestinal bleeding. Additionally, cases of tinnitus and hearing loss have been documented. There have been instances of Reye's syndrome reported in children and teenagers who used aspirin during viral infections. Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have also been noted in patients taking aspirin. Furthermore, some patients experienced liver function abnormalities during postmarketing surveillance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have a known allergy to aspirin or any other pain relievers or fever reducers.

Patients should be instructed not to use the medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. Additionally, they should refrain from using the medication for at least 7 days following a tonsillectomy or oral surgery.

Healthcare providers should counsel patients to stop using the medication and consult a doctor if they experience any allergic reactions, persistent pain or fever, new or unexpected symptoms, redness or swelling, or if they notice ringing in the ears or loss of hearing.

It is also important for healthcare providers to recommend that patients consult a doctor before using the medication if they have asthma, ongoing stomach issues (such as heartburn, upset stomach, or stomach pain), a history of ulcers or bleeding problems, or if they have a child experiencing arthritis pain. Furthermore, patients should be advised to seek medical guidance if they are allergic to aspirin or if they are taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the packets at room temperature to maintain their efficacy. Healthcare professionals are advised to avoid using any packets that are opened or torn, as this may compromise the product's quality and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to chew 4 to 8 tablets with water every 4 hours, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, it is advised to consult a doctor before administration.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)