Adult Low Dose Aspirin

Description

Heivy® is an adult low dose aspirin formulation, available in delayed release tablet form, containing 81 mg of active ingredient per tablet. This nonsteroidal anti-inflammatory drug (NSAID) is designed to provide pain relief. The tablets are enteric coated to facilitate gastrointestinal tolerance. Each bottle contains 1000 tablets. The product is identified by NDC 84014-532-10. 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 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 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 blood-thinning medications (anticoagulants) or steroid drugs.

• 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 Children and teenagers recovering from chickenpox or flu-like symptoms should avoid using this product. 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 professionals should advise patients to consult a doctor prior to use 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, it is imperative to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). 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 that does not improve.

• Any signs of an allergic reaction.

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, as these may signify a serious condition.

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, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of experiencing stomach bleeding 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, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), 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. These individuals should 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 medical consultation include the occurrence of an allergic reaction, ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, redness or swelling in the painful area, or the emergence of new symptoms. These signs could indicate a serious underlying 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 prior to initiating therapy with this drug if they are currently using any NSAIDs.

Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional or pharmacist before using this drug to ensure safe and effective treatment.

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. It is important to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

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, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

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 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 prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy, 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 degree 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 or treatment regimens may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the course of treatment.

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 severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 the product. Reports have included gastrointestinal bleeding, allergic reactions such as anaphylaxis, and Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Additional reactions noted are tinnitus (ringing in the ears), hearing loss, stomach pain, and nausea and vomiting. These reactions may occur in patients using the product, and healthcare providers should be aware of these potential risks.

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 immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against using the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be informed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, experiencing persistent stomach pain, or if an allergic reaction occurs. Immediate medical assistance should be sought in such cases.

Patients should also be advised to stop using the medication and consult a doctor if they experience ringing in the ears or loss of hearing. Additionally, they should be informed to seek medical advice if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, or if there is redness or swelling in the painful area. New symptoms should also prompt a consultation with a healthcare provider, as they may indicate a serious condition.

Before using the medication, patients should be encouraged to consult a doctor if they have asthma, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Patients taking diuretics or prescription medications for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this medication. Furthermore, individuals under a doctor's care for any serious condition should also seek guidance before use, as should those taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident safety seal. It is essential to ensure that the safety seal under the cap is intact; the product should not be used if the seal is broken or missing.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 20-25ºC (68-77ºF). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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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