Aspirin

Description

exchange✓select™ contains Aspirin as the active ingredient, with a strength of 81 mg per enteric coated tablet. The product is presented in a dosage form of enteric coated tablets, with a total quantity of 120 tablets per container. It is indicated as a pain reliever and classified as a nonsteroidal anti-inflammatory drug (NSAID). The tablets feature a safety coating and are packaged with a tamper-evident seal; the product should not be used if the imprinted safety seal under the cap is broken or missing. exchange✓select™ is manufactured for Your Military Exchange and distributed by LNK International, Inc., Hauppauge, NY 11788.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use 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.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily intake must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a physician.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in 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 illness.

Aspirin may provoke severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma (wheezing). 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 increases under certain conditions, including concurrent use of other NSAIDs (prescription or nonprescription), prolonged use beyond the recommended duration, a history of stomach ulcers or bleeding disorders, concurrent use of anticoagulants or steroid medications, consumption of three or more alcoholic beverages daily, and in individuals aged 60 years or older.

Healthcare providers should advise patients to consult a physician prior to use 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 if they are taking diuretics or have asthma. Additionally, patients should be encouraged to discuss their use of prescription medications for gout, diabetes, or arthritis with their healthcare provider or pharmacist before starting this product.

In the event of an 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 an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms warranting immediate medical attention include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever persisting beyond 3 days, visible redness or swelling, or the emergence of new symptoms, as these may signal a serious underlying condition.

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 symptoms may indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction increases under certain conditions, including the concurrent use of other NSAIDs (either prescription or nonprescription), prolonged use beyond the directed duration, a history of stomach ulcers or bleeding problems, the use of blood-thinning medications or steroids, consumption of three or more alcoholic drinks daily while using the product, and in patients aged 60 years or older.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the emergence of new symptoms. These could signify a serious condition requiring immediate medical evaluation.

Drug Interactions

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription agents such as aspirin, ibuprofen, and naproxen, may significantly increase the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these medications concurrently and consider alternative therapies or enhanced monitoring for patients at risk.

Additionally, the use of anticoagulants or steroid medications alongside the drug in question also elevates the risk of severe stomach bleeding. It is advisable to assess the necessity of these agents in conjunction with the drug and to monitor patients closely for any signs of gastrointestinal complications.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. For children and teenagers who are experiencing or recovering from chicken pox or flu-like symptoms, the use of this product is contraindicated due to the risk of Reye's syndrome, a rare but serious illness.

In the event that changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For patients 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 healthcare provider.

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 this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of gestation or later 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have underlying 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 or specific monitoring parameters may be necessary based on the severity of hepatic impairment. Therefore, healthcare providers should assess the patient's overall health status, including any comorbidities such as high blood pressure or heart disease, before initiating treatment.

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 to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, shock, facial swelling, and asthma (wheezing). Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly among patients who concurrently use other prescription or nonprescription NSAIDs, exceed the recommended dosage, have a history of stomach ulcers or bleeding disorders, take anticoagulant or steroid medications, consume three or more alcoholic beverages daily while using aspirin, or are aged 60 years or older.

Adverse reactions documented in the postmarketing experience include signs indicative of stomach bleeding, such as vomiting blood, the presence of bloody or black stools, feelings of faintness, and persistent stomach pain. Other reported adverse reactions encompass tinnitus or hearing loss, exacerbation of pain lasting more than 10 days, fever that worsens or persists beyond 3 days, the appearance of redness or swelling, and the emergence of new symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop using the product and contact their healthcare provider.

Furthermore, patients should be informed to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that persists beyond 3 days. Any signs of redness or swelling, as well as the emergence of new symptoms, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to discuss any existing medical conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics, asthma medications, or prescription drugs for gout, diabetes, or arthritis. This ensures that patients are fully informed and can use the product safely.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or other healthcare providers prior to using this product, particularly in relation to heart health. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)