Aspirin/Caffeine/Acetaminophen

Description

Rugby Pain Reliever Plus is a combination analgesic formulation containing acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, with a composition of 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine per caplet. This product is indicated for the relief of pain and is comparable to the active ingredients found in Excedrin® Extra Strength Caplets. Each bottle contains 100 caplets. It is important to note that this product is not intended for households with young children. The National Drug Code (NDC) for Rugby Pain Reliever Plus is 0536-1326-01.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, the common cold, arthritis, toothache, and premenstrual and menstrual cramps.

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 2 caplets every 6 hours as needed. It is imperative not to exceed 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Similarly, acetaminophen has the potential to cause severe skin reactions, including skin reddening, blisters, and rash. Should any skin reaction occur, discontinuation of the product and prompt medical assistance are necessary.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if the product is taken in conjunction with other medications containing acetaminophen, if more than 8 caplets are consumed within a 24-hour period, or if the individual consumes 3 or more alcoholic drinks daily while using this product.

The presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those who take more than the recommended dosage or for an extended duration, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or steroid medications. Additionally, the risk is heightened for those consuming 3 or more alcoholic drinks daily while using this product.

Caffeine is also a component of the recommended dose, which is comparable to the caffeine content of a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during the use of this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, individuals taking diuretics should seek medical advice before using this product.

In the event of an accidental overdose, immediate medical attention is critical. Patients should contact a Poison Control Center (1-800-222-1222) without delay, regardless of the presence of symptoms.

Patients are advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, including feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Immediate medical help is also warranted for allergic reactions, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the painful area, or the emergence of any new symptoms, as these may indicate a serious condition.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious Adverse Reactions 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. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

Severe allergic reactions may occur, particularly in patients sensitive to aspirin or acetaminophen. Symptoms of a severe allergic reaction to aspirin may include hives, facial swelling, shock, and asthma (wheezing). For acetaminophen, severe skin reactions can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients should discontinue use and seek medical assistance immediately.

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they take more than 8 caplets in 24 hours, consume three or more alcoholic drinks daily while using this product, or use other medications containing acetaminophen.

The product contains an NSAID, which may increase the risk of severe stomach bleeding. This risk is heightened in patients aged 60 or older, those who take more than directed or for an extended period, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners, steroids, or other NSAIDs.

Common Adverse Reactions Patients may also experience less severe but common adverse reactions. Caffeine, present in the recommended dose of this product, can lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat if consumed in excess. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product.

Monitoring and Consultation Patients are advised to stop use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, any occurrence of an allergic reaction warrants immediate medical attention. Other symptoms that require consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever persisting for more than 3 days, redness or swelling in a painful area, or the emergence of any new symptoms, as these could indicate a serious condition.

Drug Interactions

Co-administration of this product with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Pharmacodynamic interactions are significant when this product is used alongside anticoagulants or steroid medications. The concomitant use of these agents increases the risk of severe gastrointestinal bleeding. Similarly, the use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, also heightens the risk of severe stomach bleeding.

Caution is advised regarding the intake of caffeine-containing medications, foods, or beverages during treatment with this product. Excessive caffeine consumption may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, tachycardia.

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

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Aspirin, Caffeine. 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 may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and over are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution and consider this heightened risk when prescribing to geriatric patients.

Additionally, it is advisable for elderly patients to consult with their healthcare provider prior to use if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. These underlying conditions may necessitate careful monitoring and potential dosage adjustments to ensure the safety and efficacy of the treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child 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 before using this medication. It is particularly important to avoid the use of 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. 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 in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease.

This product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be aware of the following precautions to minimize the risk of hepatotoxicity:

• The maximum recommended dosage should not exceed 8 caplets within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated.

• Consumption of 3 or more alcoholic drinks daily while using this product is not advised, as it may exacerbate the risk of liver damage.

Monitoring of liver function may be warranted in patients with hepatic impairment who are prescribed this product, and any signs of liver dysfunction should be promptly evaluated.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious effects from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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

Postmarketing experience has identified several important safety considerations associated with the use of acetaminophen. Reports indicate that acetaminophen may lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there is a warning regarding the potential for severe liver damage, particularly when acetaminophen is taken in conjunction with other products containing acetaminophen, when exceeding the maximum daily dosage of 8 caplets within a 24-hour period, or when consumed alongside three or more alcoholic drinks daily.

The product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in individuals aged 60 or older, those who take the medication for longer than directed, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other NSAIDs. Consumption of three or more alcoholic drinks daily while using this product further elevates this risk.

Users are advised to discontinue use and consult a healthcare professional if any allergic reactions occur, if symptoms such as ringing in the ears or hearing loss develop, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if the painful area becomes red or swollen, or if any new symptoms arise, as these may indicate a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer.

It is important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be instructed to stop using the medication and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Additionally, they should seek immediate medical help if they experience an allergic reaction, ringing in the ears, or loss of hearing. Patients should also be advised to contact their healthcare provider if their pain worsens or lasts longer than 10 days, if their fever worsens or lasts more than 3 days, if the painful area becomes red or swollen, or if any new symptoms arise, as these may indicate a serious condition.

Before using the medication, patients should be encouraged to consult with their healthcare provider if they have liver disease, if the warning for stomach bleeding applies to them, if they have a history of stomach problems such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma or those taking a diuretic should also seek advice from their healthcare provider prior to use.

Furthermore, patients should be advised to consult with a doctor or pharmacist before using the medication if they are taking a prescription drug for diabetes, gout, or arthritis, or if they are taking any other medication or are under a doctor’s care for any serious condition.

Storage and Handling

The product is supplied in a package that includes the National Drug Code (NDC) number, which is essential for identification and inventory management. It is recommended to store the product in a dry place, maintaining a temperature range of 15° to 30°C (59° to 86°F).

Healthcare professionals should ensure that the product is used by the expiration date indicated on the package to guarantee its efficacy and safety. Proper storage and adherence to the expiration date are crucial for maintaining the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)