Aspirin

Description

Rugby® is a low dose aspirin formulation containing 81 mg of aspirin per tablet, classified as a nonsteroidal anti-inflammatory drug (NSAID). The product is presented in the form of 120 enteric-coated tablets, designed for safety and to minimize gastrointestinal irritation. The tablets are coated to ensure proper release in the intestine. The National Drug Code (NDC) for this product is 0536-1234-41. This formulation is comparable to the active ingredient found in Bayer® Low Dose Aspirin. It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Bayer® Low Dose Aspirin. The packaging includes a tamper-evident safety seal; the product should not be used if the seal under the cap is broken or missing.

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.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. 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 dosage must not exceed 48 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.

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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and 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 but not limited to: exceeding the recommended dosage or duration of use, concurrent use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), a history of stomach ulcers or bleeding disorders, concomitant use of anticoagulants or steroid medications, being aged 60 years or older, or consuming three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of asthma, if the stomach bleeding warning is applicable, if they have experienced stomach issues such as heartburn, if they are taking diuretics, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

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. They should also seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three 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. 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.

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

This 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 prolonged use beyond the directed dosage, concurrent use of other NSAIDs (whether prescription or nonprescription), a history of stomach ulcers or bleeding problems, use of blood-thinning medications or steroids, being aged 60 or older, or consuming three or more alcoholic drinks daily while using this product.

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 attention.

Drug Interactions

Co-administration of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription agents such as aspirin, ibuprofen, and naproxen, may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these medications concurrently.

The concomitant use of anticoagulants or steroid medications may also heighten the risk of stomach bleeding. It is advisable for healthcare providers to monitor patients closely and consider dosage adjustments as necessary when these agents are used in combination.

Patients taking prescription medications for conditions such as gout, diabetes, or arthritis should consult their healthcare provider to ensure safe and effective use of their treatment regimen.

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

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

For pediatric patients under 12 years of age, the use of this product is not recommended unless directed by a healthcare professional. In contrast, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a doctor.

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 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 prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin if explicitly directed by a healthcare provider.

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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree 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. 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 substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of overdose related to the specific agent involved.

It is critical to document all relevant information regarding the overdose, including the substance, amount ingested, time of ingestion, and any symptoms presented, to facilitate effective treatment and follow-up care.

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 shown that aspirin may cause severe allergic reactions, which can include hives, facial swelling, shock, and asthma (wheezing). Additionally, it has been indicated that the use of aspirin may lead to severe stomach bleeding, particularly in individuals who exceed the recommended dosage, use other nonsteroidal anti-inflammatory drugs (NSAIDs), have a history of stomach ulcers or bleeding problems, take blood thinners or steroids, are aged 60 or older, or consume three or more alcoholic drinks daily while using the product.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help 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 are allergic to aspirin or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using the product if they have ever experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to stop using the product and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away. They should also be made aware of the signs of stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing stomach pain that does not improve. In such cases, patients should be advised to stop use and contact a healthcare professional.

Furthermore, patients should be informed to discontinue use and consult a doctor if they experience ringing in the ears or a loss of hearing, if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be advised to seek medical advice if new symptoms arise, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have asthma, if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn. It is also important to recommend that patients speak with a doctor before use if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Lastly, patients should be advised to consult a doctor or pharmacist before using the product if they are taking prescription medications for gout, diabetes, or arthritis.

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 tracking and usage.

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)