Adult Low Dose

Description

Aspirin Enteric Coated Tablets are formulated to deliver 81 mg of aspirin per tablet. The product is available in two National Drug Codes (NDC): 71309-003-05 and 71309-003-10. Each bottle contains either 500 or 1000 tablets, designed for enteric coating to minimize gastrointestinal irritation.

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 action, this product is not suitable for the fast relief of headaches or other symptoms requiring immediate alleviation. Healthcare providers may consider discussing additional uses for 81 mg Aspirin with 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. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event 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 while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a physician prior to use if they have asthma, if the warning regarding stomach bleeding applies to them, if they have a history of gastrointestinal issues such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or any prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare provider before using this product. It is also advisable for patients under medical care for any serious condition to discuss the use of this product with their doctor or pharmacist.

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 attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. An allergic reaction necessitates immediate medical attention. Other concerning symptoms that warrant consultation include 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, or the emergence of new symptoms, as these may indicate a serious underlying condition.

Side Effects

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

Reye's syndrome is a rare but serious illness that may 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 symptoms could indicate the onset of Reye's syndrome.

Aspirin, a component of this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing). Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The risk 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.

Patients should seek medical advice before using this product if they have asthma, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics. Additionally, patients taking prescription medications for diabetes, gout, or arthritis, or those under a doctor's care for any serious condition, should consult a healthcare professional prior to use.

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 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 could indicate a serious condition requiring immediate medical intervention.

Drug Interactions

Aspirin has been associated with significant drug interactions that may increase the risk of adverse effects, particularly gastrointestinal bleeding.

Anticoagulants and Antiplatelet Agents The concomitant use of aspirin with anticoagulants or antiplatelet agents may lead to an increased risk of severe stomach bleeding. It is advisable for patients to consult their healthcare provider prior to initiating aspirin therapy if they are currently on any blood-thinning medications.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The use of aspirin in conjunction with other NSAIDs, whether prescription or nonprescription (such as ibuprofen or naproxen), can further elevate the risk of gastrointestinal bleeding. Patients should be monitored closely for signs of bleeding and should seek medical advice if they are considering the use of aspirin alongside other NSAIDs.

Other Considerations Patients taking prescription medications for diabetes, gout, or arthritis should consult their healthcare provider before using aspirin. This is to ensure that potential interactions are managed appropriately and to assess the need for any dosage adjustments or additional monitoring.

Packaging & NDC

Below are the non-prescription pack sizes of Adult Low Dose (aspirin 81 mg). 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 accompanied by nausea and vomiting occur, as these may be early indicators of Reye's syndrome.

For children under 12 years of age, consultation with a doctor is advised prior to use. For adolescents and adults aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have 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 gastrointestinal complications is advised, and dosage adjustments should be considered based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

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 the unborn child 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, 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking a diuretic, as this may influence the management of their condition and the medication's efficacy.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no pertinent data provided in the nonclinical toxicology section or in the animal pharmacology and toxicology assessments.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, and Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Additional reported events encompass tinnitus (ringing in the ears), hearing loss, stomach ulcers, liver damage, and kidney damage. Furthermore, asthma exacerbation and various skin reactions, including hives and rashes, have also been documented. Other serious allergic reactions were noted as well. It is important to recognize that these adverse reactions may not have been observed during clinical trials.

Patient Counseling

Patients should be advised to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to discontinue use and consult a healthcare provider 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 help should be sought in such cases.

Additionally, patients should stop using the medication and consult a doctor if they notice ringing in the ears or experience any loss of hearing. They should also seek medical advice if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, or if there is redness or swelling in the affected area. New symptoms that arise 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 discuss their medical history with their healthcare provider, particularly if they have asthma, a history of stomach problems such as heartburn, or if the warning for stomach bleeding applies to them. It is also important for patients to inform their healthcare provider if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Patients taking diuretics or prescription medications for diabetes, gout, or arthritis should consult their doctor or pharmacist prior to use. Furthermore, those under a doctor's care for any serious condition should also seek guidance before using this medication. Lastly, patients should be reminded to consult their healthcare provider or pharmacist if they are taking any other drugs to avoid potential interactions.

Storage and Handling

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

For optimal storage, the product should be maintained at room temperature, specifically within the range of 15-30ºC (59-86ºF). Proper handling and storage conditions are crucial to preserve 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 specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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