Extra Strength Pain Reliever

Description

This product contains acetaminophen as the active ingredient, providing 500 mg per tablet. It is classified as an extra strength pain reliever and fever reducer. Each pouch contains two tablets, designed for effective management of pain and reduction of fever. The formulation is comparable to the active ingredient found in Tylenol® Extra Strength.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 tablets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

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

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, and it is imperative to adhere to the maximum daily dosage of 6 tablets (3,000 mg) within a 24-hour period. Exceeding 4,000 mg of acetaminophen in 24 hours, using this product in conjunction with other medications containing acetaminophen, or consuming three or more alcoholic beverages daily while using this product may lead to severe liver damage.

Healthcare professionals should be vigilant for the potential of severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is crucial to discontinue use immediately and seek medical assistance.

Prior to recommending this product, it is advisable to consult a physician if the patient has a history of liver disease. Additionally, patients taking the anticoagulant warfarin should also seek medical advice before use, as interactions may occur.

In the event of an overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than 10 days, fever that persists or worsens beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the acetaminophen content of their medications are advised to consult a healthcare professional. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use.

Prior to using this product, patients with liver disease should consult a healthcare provider. Furthermore, those taking the anticoagulant warfarin should also seek medical advice before use.

Patients are instructed to stop using the product and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

An overdose warning is in place, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider or pharmacist.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pain Reliever (acetaminophen 500 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the treatment. Additionally, those taking the anticoagulant warfarin should also seek medical advice before initiating therapy, due to potential interactions that could increase the risk of bleeding.

For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a healthcare professional. It is important for geriatric patients to adhere to the guideline of not using the medication for more than 10 days unless specifically instructed by a doctor, to avoid potential complications associated with prolonged use.

For children under 12 years of age, it is advised to consult a healthcare provider before administration to ensure appropriate dosing and safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, as liver disease may affect the safety and efficacy of treatment. This product contains acetaminophen, and it is crucial to adhere to the maximum daily dose of 6 tablets (3,000 mg) within a 24-hour period.

Patients are advised that exceeding 4,000 mg of acetaminophen in 24 hours can lead to severe liver damage. Additionally, the risk of severe liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen.

Consumption of 3 or more alcoholic drinks daily while using this product may also heighten the risk of severe liver damage. It is imperative that patients do not exceed the recommended dosage, as an overdose can result in liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, it is recommended to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, as quick intervention can mitigate the risk of severe complications, even in the absence of noticeable signs or symptoms.

Healthcare providers should remain vigilant and ensure that patients and caregivers are aware of the importance of timely medical evaluation following an overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Patients should be advised about the importance of adhering to the recommended dosage of the medication. Taking more than the recommended dose may lead to serious health consequences, including potential liver damage.

In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate the risks associated with overdose situations.

Storage and Handling

The product is supplied in a secure inner pouch and carton. It is imperative that the product is not used if either the inner pouch or carton is open or damaged, as this may compromise the integrity of the product.

For optimal storage, the product should be maintained at room temperature, specifically within the range of 59-86°F (15-30°C). Healthcare professionals are advised to check the bottom panel of the packaging for the lot number and expiration date to ensure the product's validity and safety prior to use.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)