Adult Low Dose Aspirin Enteric Coated

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for other uses as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Healthcare providers are encouraged to discuss additional potential uses of this product with their patients. 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 for optimal efficacy.

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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs and ensure that patients are aware of the potential for allergic responses.

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 patients 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 any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before use.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention is also warranted if an allergic reaction occurs. Furthermore, patients should seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if redness or swelling develops, if any new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Warnings 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. These individuals should not use this product. If patients experience 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.

An allergy alert is also pertinent, as aspirin may cause severe allergic reactions. 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.

Additionally, this 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 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.

Common Adverse Reactions Patients are advised to stop using the product 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. Other reasons to discontinue use and seek medical advice include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, presence of redness or swelling, occurrence of any new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Adult Low Dose Aspirin Enteric Coated (aspirin 81mg). 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 pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

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

Monitoring for signs of gastrointestinal bleeding is recommended, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this therapy.

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 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 if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly directed by a healthcare provider, 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.

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 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 accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if the patient presents within a suitable timeframe and is alert, as well as providing intravenous fluids and other supportive measures as indicated.

It is vital for healthcare professionals to remain vigilant and prepared to implement emergency protocols in cases of suspected overdose, ensuring the safety and well-being of the patient.

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 indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), and shock. Additionally, reports have highlighted instances of stomach bleeding, particularly among patients aged 60 years or older, those with a history of stomach ulcers or bleeding issues, individuals taking anticoagulant or steroid medications, users of other NSAIDs (both prescription and nonprescription), and those consuming three or more alcoholic drinks daily while using this product.

Signs of stomach bleeding reported in the postmarketing experience include symptoms such as feeling faint, vomiting blood, passing bloody or black stools, and persistent stomach pain. Other adverse reactions noted include allergic reactions, exacerbation of pain, fever lasting more than three days, redness or swelling, the emergence of new symptoms, and tinnitus or hearing loss.

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 accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer. Additionally, they should avoid use if they have previously experienced an allergic reaction to this product or any of its ingredients.

Healthcare providers should counsel patients to discontinue use 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. Patients should also be advised to stop use and seek medical attention if they experience an allergic reaction, if pain worsens or lasts more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if any new symptoms arise. Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to recommend that patients ask a doctor before use if the stomach bleeding warning applies to them, especially if they have a history of stomach problems such as heartburn. Patients should also be advised to consult a doctor before use if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as if they have asthma or are taking a diuretic. Lastly, patients should be encouraged to speak with a doctor or pharmacist before use if they are taking a prescription drug for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, within the range of 15° to 30°C. Care should be taken to avoid exposure to excess heat and moisture, as these conditions may compromise the integrity of the product. Additionally, the product should not be used if the safety seal under the cap is broken or missing, ensuring that only intact and safe products are utilized.

Additional Clinical Information

The medication is administered orally. For adults and children 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 physician. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to discuss any heart-related concerns with their healthcare provider before using this product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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