Extraprin

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 6 hours, with a maximum limit of 8 caplets within a 24-hour period. It is essential that each dose is accompanied by a full glass of water to ensure proper administration and absorption.

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

Contraindications

Use of this product is contraindicated in individuals with a history of allergic reactions to acetaminophen, aspirin, or other pain relievers/fever reducers. Additionally, concurrent use with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. 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 currently experiencing or recovering from chickenpox or flu-like symptoms should refrain from using this product. If any behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye’s syndrome, a rare but potentially serious condition.

Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any skin reaction manifest, it is crucial to discontinue use immediately and seek medical assistance.

Aspirin, also present in this formulation, can provoke severe allergic reactions. Symptoms may encompass hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is warranted if an allergic reaction occurs.

This product contains acetaminophen, and it is essential to adhere to the recommended dosage. Severe liver damage may result from exceeding 8 caplets within a 24-hour period, which is the maximum daily limit, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily during treatment.

Additionally, this product includes a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of such an event increases in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, and patients concurrently taking anticoagulants or steroid medications. The risk is also heightened for those using other NSAIDs (including aspirin, ibuprofen, or naproxen), consuming three or more alcoholic drinks daily, or exceeding the recommended duration or dosage.

In the event of an overdose, it is critical to seek immediate medical attention or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

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

Side Effects

Patients using this product should be aware of several serious and common adverse reactions.

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 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.

Severe skin reactions have been reported, which may manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. Patients should seek medical attention if any of these symptoms occur.

The product carries a liver warning, indicating that severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets within 24 hours, particularly when combined with other drugs containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Additionally, 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 are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), or consume three or more alcoholic drinks daily while using this product. Patients should be vigilant for signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve.

Patients are advised to stop using the product and seek medical attention if they experience any of the following: an allergic reaction, ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, or any new symptoms. These could indicate a serious condition requiring immediate medical evaluation.

Drug Interactions

The concurrent use of this product with caffeine-containing medications, foods, or beverages should be limited. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Co-administration with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for hepatotoxicity.

Patients taking prescription medications for diabetes, gout, or arthritis are advised to consult a healthcare professional prior to using this product to avoid possible interactions.

This product is contraindicated in patients who are receiving anticoagulant therapy or steroid medications, as these combinations may increase the risk of bleeding or other adverse effects.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, is not recommended due to the potential for increased risk of gastrointestinal complications and renal impairment.

Packaging & NDC

Below are the non-prescription pack sizes of Extraprin (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. It is important to consult a doctor if changes in behavior accompanied by nausea and vomiting occur, as these may be early signs of Reye’s syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are recommended 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.

Additionally, the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Therefore, the use of other caffeine-containing medications, foods, or beverages should be limited while taking this product, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Therefore, it is essential for healthcare providers to exercise caution when prescribing medications to this population.

Before initiating treatment, it is advisable for geriatric patients to consult with their healthcare provider if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those with a prior history of stomach problems, such as heartburn, should also seek medical advice prior to use.

It is critical to adhere to the recommended dosage guidelines, as elderly patients should not exceed the directed dosage, particularly if they are 60 years of age or older. Monitoring for adverse effects and ensuring appropriate dose modifications may be necessary to enhance safety and efficacy in this demographic.

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 healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 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 of this medication. It is essential for patients with liver disease, including those with liver cirrhosis, to seek medical advice to ensure safe and effective use.

Due to the potential impact of compromised liver function on drug metabolism and clearance, careful consideration and monitoring are advised for patients with hepatic impairment. Additionally, patients with concurrent conditions such as high blood pressure or heart disease should be closely monitored to assess any potential interactions or exacerbations of their underlying health issues.

Healthcare providers may need to adjust dosages or implement specific monitoring protocols based on the severity of the hepatic impairment and the overall health status of the patient.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive 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

Severe skin reactions have been reported in association with acetaminophen use. Symptoms may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock.

Additionally, aspirin has been associated with severe allergic reactions, which may manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a controlled room temperature of 20°-25°C (68°-77°F) to ensure its stability and efficacy.

After each use, it is crucial to close the cap tightly to maintain the integrity of the product and prevent contamination. Proper handling and storage conditions are vital for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 caplets every 6 hours, not exceeding 8 caplets within a 24-hour period for adults and children aged 12 years and older. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly critical to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)