Dye-Free Aspirin 81

Description

The product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the fast relief of headaches or other symptoms requiring immediate alleviation. Healthcare providers may be consulted regarding additional uses for enteric coated 81 mg Aspirin.

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

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must 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 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. Additionally, the product should not be administered to patients who have a history of allergic reactions to this product or any of its components.

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 this rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

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

Healthcare providers should advise patients to consult a physician prior to using this product if they have asthma, if the stomach bleeding warning applies to them, if they have a history of gastrointestinal issues such as heartburn, if they are on diuretics, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should be encouraged to seek guidance from a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical advice promptly.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye’s syndrome is a rare but serious illness that can 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 may be early signs of Reye’s syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should seek immediate medical attention if any signs of an allergic reaction occur.

The product 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, 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 signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other reasons to discontinue use include worsening pain lasting more than 10 days, fever lasting more than 3 days, presence of redness or swelling, occurrence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have asthma, if the stomach bleeding warning applies to them, if they have a history of stomach problems (such as heartburn), if they are taking a diuretic, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for gout, diabetes, or arthritis.

In terms of pharmacodynamic interactions, the risk of severe stomach bleeding is increased when this medication is used in conjunction with anticoagulants (blood thinners) or steroid medications. It is advisable for healthcare providers to monitor patients closely for signs of gastrointestinal bleeding in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Dye-Free Aspirin 81 (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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs and symptoms of gastrointestinal bleeding is advised in this population, and appropriate dose adjustments should be considered based on individual patient factors. Careful assessment of the benefits and risks is crucial when treating elderly patients, especially those with a history of gastrointestinal issues or those taking concomitant medications that may exacerbate bleeding risks.

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 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 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 and effective 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide supportive care and monitor the patient closely for any adverse effects that may arise from 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 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 this 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.

Patients must be cautioned against using this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should also refrain from use if they have previously experienced an allergic reaction to this product or any of its ingredients. In the case of an allergic reaction, patients should stop using the medication and seek medical assistance without delay.

Healthcare providers should inform patients to 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 stomach pain that does not improve. Additionally, patients should 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 is present, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

Patients should be encouraged to consult a doctor before using this medication if they have asthma or if they have a history of stomach problems, such as heartburn. It is also important for patients to seek medical advice if the warning regarding stomach bleeding applies to them, or if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should be advised to speak with a doctor or pharmacist before use if they are taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dye-Free Aspirin 81, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)