Adult Low Dose Aspirin

Description

Heivy® is an adult low dose aspirin formulation, available in delayed release tablet form, with each tablet containing 81 mg of the active ingredient. This nonsteroidal anti-inflammatory drug (NSAID) is designed to provide pain relief. The tablets are enteric coated to facilitate gastrointestinal tolerance. Each bottle contains 300 tablets. The product is identified by NDC 84014-531-03. It is important to note that this product is not manufactured or distributed by Bayer HealthCare LLC., the owner of the registered trademark Bayer® Low Dose Aspirin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains as recommended by a healthcare professional. Due to its delayed release action, it is not suitable for the fast relief of headaches or symptoms requiring immediate alleviation.

Limitations of Use: 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 hydration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed for symptom relief. It is important not to 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 is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Aspirin is associated with several significant warnings and precautions that healthcare professionals must consider to ensure safe use.

Allergy Alert Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Immediate medical attention is warranted if any of these symptoms occur.

Stomach Bleeding Warning As an NSAID, aspirin carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals 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 anticoagulants or steroid medications

• Are taking other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

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

• Exceed the recommended dosage or duration of use

Reye's Syndrome Aspirin should not be administered to children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms. If behavioral changes accompanied by nausea and vomiting occur during use, it is crucial to consult a physician, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

General Precautions Healthcare providers should advise patients to consult a physician prior to using aspirin if they have:

• Asthma

• A history of stomach issues, including heartburn

• High blood pressure, heart disease, liver cirrhosis, or kidney disease

• Ongoing treatment with diuretics

Additionally, patients should seek guidance from a doctor or pharmacist if they are:

• Taking prescription medications for diabetes, gout, or arthritis

• Under medical supervision for any serious health condition

• Using any other medications

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Discontinuation and Consultation Patients should discontinue use and contact a healthcare provider if they experience any of the following signs indicative of potential stomach bleeding:

• Feeling faint

• Presence of bloody or black stools

• Vomiting blood

• Persistent stomach pain

• Any allergic reactions

Additionally, medical attention should be sought if patients experience:

• Ringing in the ears or hearing loss

• Worsening pain lasting more than 10 days

• Fever that worsens or persists beyond three days

• Redness or swelling in the affected area

• The emergence of new symptoms

These signs may indicate a serious underlying condition that requires immediate evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, shock, facial swelling, or asthma (wheezing). Additionally, the 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Reye's syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. It is advised that these individuals avoid using this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome.

Patients are advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include allergic reactions, ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever persisting for more than 3 days, redness or swelling in the painful area, or the emergence of new symptoms.

Before using this product, patients should consult a healthcare provider if they have asthma, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also recommended that patients inform their doctor if they are taking diuretics, prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question.

Additionally, the concurrent administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, is associated with an increased risk of severe stomach bleeding. It is advisable for patients to consult with their healthcare provider or pharmacist prior to initiating therapy with this drug if they are currently taking any prescription medications for diabetes, gout, or arthritis.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. It is important to consult a healthcare professional if any changes in behavior occur alongside nausea and vomiting, as these may be early indicators of Reye's syndrome.

For children under 12 years of age, it is advised to seek medical guidance before use. For those aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed while symptoms persist, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a physician.

Geriatric Use

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

It is essential for healthcare providers to assess the overall health status of geriatric patients prior to initiating treatment. Patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult with their healthcare provider before use. Close monitoring and appropriate dosage adjustments may be necessary to ensure safety and efficacy in this demographic.

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 outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician.

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 should consult a healthcare professional prior to use, particularly if they have comorbid 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of aspirin. Reports indicate that gastrointestinal bleeding may occur, particularly in patients with a history of ulcers or those concurrently using anticoagulants. Additionally, allergic reactions, including cases of anaphylaxis, have been documented. Tinnitus has also been reported as a potential adverse effect in patients taking aspirin. These events were reported voluntarily or through surveillance programs and do not imply a causal relationship.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

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 20-25ºC (68-77ºF).

It is essential to ensure that the product is handled with care. The container is designed to be tamper evident; therefore, it must not be used if the safety seal under the cap is broken or missing.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless explicitly 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 Adult Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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