Enteric Coated Aspirin

Description

Enteric Coated Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) designed for pain relief. Each tablet contains 325 mg of the active ingredient, formulated with a safety coating to enhance gastrointestinal tolerance. The product is supplied in a bottle containing 125 tablets, ensuring a convenient dosage form for therapeutic use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscle pain, toothache, menstrual pain, colds, and minor pain of arthritis. It may also be used as recommended by a healthcare professional.

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

Dosage and Administration

Patients are advised to 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 1 to 2 tablets every 4 hours as needed. It is important not to exceed a total of 12 tablets within a 24-hour period to avoid potential overdose.

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

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should not be administered this product.

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, a component of this product, has the potential to cause severe allergic reactions, which may manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which is associated with an increased risk of severe stomach bleeding. The risk is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using blood thinners (anticoagulants) or steroid medications, are taking 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.

It is contraindicated to use this product in individuals with a known allergy to any other pain reliever or fever reducer. Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if the individual is taking a diuretic. Furthermore, consultation with a doctor or pharmacist is recommended for those taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and seek medical advice if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, presence of redness or swelling, emergence of new symptoms, or occurrences of ringing in the ears or hearing loss. These symptoms may signify a serious medical condition requiring prompt attention.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

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 experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms may indicate the onset of this rare but serious illness.

Additionally, patients may experience severe allergic reactions to aspirin, which can manifest as hives, facial swelling, shock, or asthma (wheezing). In such cases, immediate medical attention is necessary.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of 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 while using this product, or exceed the recommended dosage or duration of use.

Patients should discontinue use and seek medical advice if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include worsening pain lasting more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

These adverse reactions highlight the importance of monitoring for serious conditions while using this product.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concomitantly with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both classes of drugs can increase the risk of bleeding.

Patients who are prescribed medications for diabetes, gout, or arthritis should consult a healthcare professional prior to initiating aspirin therapy. This is crucial to ensure safe use and to evaluate the need for any dosage adjustments or enhanced monitoring for adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Enteric Coated 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 dosing, children under 12 years of age should seek medical advice before use. For those aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours, with a maximum limit of 12 tablets within a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

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 prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment of the patient is essential to determine the appropriate course of action.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient’s vital signs and clinical status is recommended to ensure prompt identification and management of any complications that may arise.

In summary, immediate medical attention and appropriate management strategies are vital in addressing overdose cases 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

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. They should be counseled to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat, and to seek medical assistance right away.

Additionally, patients should be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should be advised to discontinue use and contact a healthcare professional if pain worsens or persists for more than 10 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult with a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or who have asthma, should also seek medical advice prior to use.

Finally, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for diabetes, gout, or arthritis to avoid potential interactions.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure its stability and efficacy. Proper storage conditions are crucial for maintaining the integrity 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 Enteric Coated Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)