Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) formulated as an 81 mg pain reliever. This product is presented in a safety-coated dosage form, with each bottle containing 120 tablets, each tablet delivering 81 mg of aspirin. The product features a tamper-evident seal; it should not be used if the safety seal under the cap is broken or missing. This formulation is not manufactured or distributed by Bayer AG, the owner of the registered trademark Bayer® Low Dose Aspirin. It is distributed by AmerisourceBergen, located at 1 West First Avenue, Conshohocken, PA 19428. For inquiries, further information can be accessed at www.mygnp.com.

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 has the potential to cause severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may include hives, shock, facial swelling, and asthma symptoms such as wheezing. Immediate medical attention is warranted if any of these symptoms occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened under certain conditions, including but not limited to the concurrent use of other NSAIDs (both prescription and nonprescription), prolonged use beyond the recommended duration, a history of stomach ulcers or bleeding disorders, concomitant use of anticoagulants or steroid medications, consumption of three or more alcoholic beverages daily while using this product, and in individuals aged 60 years or older.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain), tinnitus or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling, or the emergence of new symptoms. These may be indicative of a serious underlying condition.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. 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 may be early signs 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 help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients who take other medications containing NSAIDs, exceed the recommended dosage or duration of use, have a history of stomach ulcers or bleeding problems, are on anticoagulant or steroid medications, consume three or more alcoholic drinks daily while using this product, or are aged 60 years or older.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other symptoms that warrant medical attention include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or the emergence of new symptoms, as these could indicate a serious condition.

Drug Interactions

The concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) with this medication may significantly increase the risk of severe gastrointestinal bleeding. This includes both prescription and over-the-counter NSAIDs such as aspirin, ibuprofen, and naproxen. Healthcare professionals should exercise caution when prescribing this medication alongside any NSAID and consider alternative therapies or enhanced monitoring for gastrointestinal adverse effects.

Additionally, the risk of severe stomach bleeding is also heightened when this medication is used in conjunction with anticoagulants (blood thinners) or steroid medications. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments or alternative treatments in such cases.

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. It is important to note that children and teenagers who have or are recovering from chickenpox or flu-like symptoms are at risk for Reye's syndrome and should avoid this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted, as these may be early signs of Reye's syndrome, a rare but serious condition.

For adolescents 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. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, 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 treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

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 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 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 to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted interventions may be employed to counteract the effects of the overdose.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

No postmarketing experience details are available in the insert text.

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 not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should 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 advised 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, or the emergence of new symptoms, should also prompt a discussion with a healthcare provider, as these may indicate a serious condition.

Patients should be encouraged to consult their 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 conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics or asthma medications. Additionally, patients taking prescription drugs for gout, diabetes, or arthritis should be advised to speak with their doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 healthcare provider prior to using this product for heart-related conditions. No further 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)