Right Remedies Low Dose Aspirin 81mg

Description

AspirinLowDose-1 is a pharmaceutical formulation containing acetylsalicylic acid as its active ingredient. The chemical formula is C9H8O4, and it has a molecular weight of 180.16 g/mol. This product is available in a low-dose tablet form, designed for oral administration. The tablets are typically white to off-white in appearance, ensuring ease of identification. Inactive ingredients may include various excipients that facilitate the formulation's stability and bioavailability.

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 professionals are encouraged to inquire about additional uses for Safety Coated 81 mg Aspirin as appropriate for their patients.

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

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 as needed. It is important not to exceed a total of 48 tablets within a 24-hour period to avoid potential overdose.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Children and teenagers recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early signs of Reye’s syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Individuals with known allergies to aspirin or any other pain reliever or fever reducer should refrain from using this product. Additionally, those who have previously experienced an allergic reaction to this product or any of its components should avoid its use.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect increases 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 professionals should be consulted prior to use if the stomach bleeding warning applies, or if the individual has a history of stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also seek medical advice before using this product.

Before using this product, it is advisable to consult a doctor or pharmacist if the patient is currently taking prescription medications for gout, diabetes, or arthritis.

Discontinuation of use and immediate consultation with a healthcare provider is warranted if an allergic reaction occurs, or if any signs of stomach bleeding are observed, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, fever intensifies or persists beyond three days, redness or swelling develops, new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

For pregnant or breastfeeding individuals, it is crucial to consult a healthcare professional before use. Aspirin should be avoided during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Side Effects

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

Serious adverse reactions include the risk of Reye’s syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a healthcare professional immediately, as these may be early signs of this rare but serious illness.

Allergic reactions to aspirin can also occur, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should be advised to stop use and seek medical attention if any signs of an allergic reaction develop.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for potential 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, consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should be vigilant for signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should discontinue use and consult a healthcare provider.

Common adverse reactions may include gastrointestinal discomfort, and patients are advised to seek medical advice if pain worsens or persists beyond 10 days, if fever worsens or lasts more than three days, or if new symptoms arise. Additionally, patients should be cautious of potential ringing in the ears or loss of hearing.

Before using this product, patients should consult a healthcare professional if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics or prescription medications for gout, diabetes, or arthritis.

Pregnant or breastfeeding patients should also seek guidance from a healthcare professional prior to use, particularly during the last three months of pregnancy, as aspirin may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Taking this product concurrently with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Clinicians should exercise caution when prescribing this product to patients who are on blood thinners, as the potential for adverse effects is increased.

Additionally, the concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, further heightens the risk of stomach bleeding. It is advisable for healthcare providers to monitor patients closely for signs of gastrointestinal complications and consider dosage adjustments or alternative therapies as necessary.

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

Packaging & NDC

Below are the non-prescription pack sizes of Right Remedies Low Dose Aspirin 81mg (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. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period. For children under 12 years of age, consultation with a healthcare provider is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in geriatric patients, especially when initiating treatment or adjusting dosages. Healthcare providers should consider the overall health status and concurrent medications of elderly patients to ensure safe and effective management.

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 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 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 while breastfeeding.

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 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 or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and timely action are essential in managing potential 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 details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of the product. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been reported, particularly among patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Reports have also indicated symptoms consistent with Reye’s syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Other adverse reactions noted include tinnitus (ringing in the ears) and loss of hearing, as well as the emergence of new symptoms following the use of the product.

It is advised that individuals seek medical attention immediately if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding.

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 safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly enhance patient safety and outcomes.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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 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.

Drug Information (PDF)

This file contains official product information for Right Remedies Low Dose Aspirin 81mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)