Aspirin

Description

Rugby® is a nonsteroidal anti-inflammatory drug (NSAID) that contains 325 mg of aspirin as its active ingredient. It is formulated as a pain reliever and fever reducer. The product is packaged in a bottle containing 100 tablets. A tamper evident warning is included, stating that the product should not be used if the imprinted safety seal under the cap is broken or missing. Rugby® is distributed by Rugby Laboratories, located in Indianapolis, IN 46268, and is not manufactured or distributed by Bayer AG, the owner of the registered trademark Genuine Bayer® Aspirin. For inquiries, contact can be made at (800) 616-2471 or through the website www.major-rugby.com. The National Drug Code (NDC) for this product is 0536-1054-29.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, pain and fever associated with colds, toothache, menstrual pain, muscle pain, and minor pain related to arthritis.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage.

For adults and children aged 12 years and older, the recommended dosage is as follows: take 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

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

Patients are advised to consume a full glass of water with each dose to ensure proper administration and absorption of the medication.

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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early indicators of Reye's syndrome.

Aspirin may provoke severe allergic reactions, which can manifest as facial swelling, hives, shock, or asthma symptoms such as 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 is increased in individuals with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals aged 60 years or older, and those who consume three or more alcoholic beverages daily while using this product. Additionally, the risk is heightened for patients taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen, especially if they exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or prescription medications for gout, diabetes, or arthritis should also seek guidance from a healthcare provider before use.

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 doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may signal a serious 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 may be early signs of Reye's syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as facial swelling, hives, shock, or asthma (wheezing). Patients should seek immediate medical attention if any signs of an allergic reaction occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients with a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals aged 60 or older, and those who consume three or more alcoholic drinks daily while using this product. Patients should also be cautious if they are taking other medications that contain NSAIDs, such as aspirin, ibuprofen, or naproxen, or if they exceed the recommended dosage or duration of use.

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 persistent stomach pain. Other concerning 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, the emergence of new symptoms, or the presence of redness or swelling. These symptoms could indicate a serious condition requiring prompt evaluation.

Drug Interactions

Aspirin has several notable interactions that may impact patient safety and treatment efficacy.

Anticoagulants Aspirin may enhance the effects of blood-thinning medications, increasing the risk of severe gastrointestinal bleeding. It is advisable for patients on anticoagulants to undergo regular monitoring for signs of bleeding and to consult their healthcare provider regarding the use of aspirin.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use of aspirin with other NSAIDs, such as ibuprofen or naproxen, may elevate the risk of stomach bleeding. Patients should be advised to avoid combining these medications unless directed by a healthcare professional.

Diuretics Aspirin may interact with diuretics, potentially compromising kidney function. Patients on diuretics should be monitored for renal function and advised to discuss aspirin use with their healthcare provider.

Other Prescription Medications Patients taking prescription medications for conditions such as gout, diabetes, or arthritis should consult their healthcare provider prior to using aspirin, as significant interactions may occur that could affect their treatment regimen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a healthcare professional. For adolescents and adults aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a physician.

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

Geriatric Use

Elderly patients, particularly those aged 60 years 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 ratio is essential when treating this population to ensure optimal safety and efficacy.

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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 pregnancy 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 high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, caution is advised for those who are taking a diuretic, as this may further impact renal function. Monitoring of renal status is recommended to ensure safe and effective use in this population.

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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate each case individually.

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 established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as shock, facial swelling, hives, and asthma (wheezing). Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly among patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, users of other prescription or nonprescription NSAIDs, and those who consume three or more alcoholic drinks daily while using this product. Furthermore, taking aspirin in excess of the recommended dosage or for prolonged periods may increase the risk of adverse effects.

Adverse reactions reported in the postmarketing experience include signs indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain. Other reported adverse reactions encompass tinnitus or hearing loss, exacerbation of pain or fever, the emergence of new symptoms, and the presence of redness or swelling.

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 should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients must 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 feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. 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 or a loss of hearing, if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days. They should also be encouraged to seek medical advice if new symptoms arise or if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should remind 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. Patients with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Additionally, those taking a diuretic or prescription medications for gout, diabetes, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible 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 medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial 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.

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)