Adult Chewable Aspirin

Description

Low Dose Adult Chewable Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. Each tablet contains 81 mg of aspirin and is formulated in an orange flavor for palatability. The product is packaged in a bottle containing 36 tablets. The National Drug Code (NDC) for this formulation is 53943-152-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Healthcare professionals are encouraged to consult with patients regarding additional potential uses for this product.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients are advised to take a full glass of water with each dose to ensure proper administration and absorption of the medication.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily 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, the use of this medication is not recommended unless specifically directed by a physician.

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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Aspirin, a component of this product, has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such bleeding is heightened in individuals 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 beverages daily while using this product, or exceed the recommended dosage or duration of use.

General precautions should be observed. This product should not be used by individuals with a known allergy to any other pain reliever or fever reducer. It is also contraindicated for use within seven days following a tonsillectomy or oral surgery unless directed by a healthcare professional. Prior to use, individuals should consult a physician if any of the following conditions apply: a history of stomach bleeding, existing stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or asthma. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and consult a physician if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than ten days, fever that worsens or persists beyond three days, presence of redness or swelling, emergence of new symptoms, or any ringing in the ears or loss of hearing. These symptoms may signify a serious medical condition requiring prompt attention.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial that these individuals do not use this product. If patients exhibit 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, a component of this product, may cause severe allergic reactions in some patients. 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 warning for the potential of severe stomach bleeding. The risk of stomach bleeding 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, fever intensifies or lasts more than three days, redness or swelling occurs, new symptoms arise, or if there is ringing in the ears or a loss of hearing, medical advice should be sought.

Before using this product, patients are advised to consult a doctor if any of the following apply: they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking diuretics; or they have asthma. Furthermore, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concomitantly with anticoagulants or steroid medications. The risk of this adverse effect is significantly increased in patients who are on these classes of drugs.

Additionally, it is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using aspirin if they are currently prescribed medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in the context of these underlying conditions.

Packaging & NDC

Below are the non-prescription pack sizes of Adult Chewable Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. The use of this product is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome.

In the event that changes in behavior accompanied by nausea and vomiting occur during use, it is essential to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome. For patients 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 provider.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is essential for healthcare providers to evaluate the risks and benefits before recommending this medication to pregnant women, especially in the later stages of pregnancy.

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 the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of 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 for potential interactions and the overall impact on treatment outcomes. It is advised that healthcare providers exercise caution and consider these factors when prescribing the medication to patients with hepatic impairment.

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 it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications 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 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients must be cautioned against using the medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to inform patients that they should not use the medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction or if they notice symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise. Furthermore, patients should be made aware that ringing in the ears or loss of hearing could be signs of a serious condition, warranting immediate medical consultation.

Healthcare providers should encourage patients to consult 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. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Additionally, those taking diuretics or who have asthma should consult a doctor before using the medication. Lastly, patients taking prescription drugs for gout, diabetes, or arthritis should be encouraged to speak with a doctor or pharmacist before starting the medication.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product details.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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