Pain Reliever

Description

Extra Strength Acetaminophen is a pain reliever and fever reducer, containing 500 mg of acetaminophen per tablet. This formulation is designed to provide effective relief from pain and reduce fever. The product is packaged in a bottle containing 10 tablets, featuring the Lil' Drug Store® logo.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including 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 older are instructed to take 2 tablets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive 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. 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 this formulation.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning The maximum daily dose of this product is 6 tablets (3,000 mg) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance.

General Precautions Patients should be advised to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, those taking the anticoagulant warfarin should also seek medical advice before use.

Emergency Medical Help In the event of an overdose, it is imperative to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

When to Stop Taking the Product Patients should discontinue use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These may be indicative of 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, 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 presence of acetaminophen in 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.

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

Patients are advised to discontinue use 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 of acetaminophen can lead to liver damage. In cases of 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 taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the prescribing physician.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever (acetaminophen tablet, extra strength). 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, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no immediate signs or symptoms are apparent.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for these patients to consult a healthcare provider prior to use if they have a history of liver disease, as this may influence the safety and efficacy of the treatment.

Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin should seek medical advice before initiating therapy, due to potential interactions that could increase the risk of bleeding.

Dosage recommendations for elderly patients include a strict limit of no more than 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Furthermore, the duration of use should not exceed 10 days unless specifically instructed by a physician.

In the event of an overdose, it is imperative for elderly patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for adults, including the elderly, even if no signs or symptoms of overdose are apparent.

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 exercise caution when using this product, which contains acetaminophen. It is essential to adhere to the maximum daily dose of 6 tablets (3,000 mg) within a 24-hour period. Patients are advised that severe liver damage may occur if they exceed 4,000 mg of acetaminophen in 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Prior to use, patients with liver disease should consult a healthcare professional. In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of this medication constitutes an overdose, which may lead to significant liver damage. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Quick intervention is crucial, as the risk of liver damage can escalate rapidly, affecting both adults and children. It is important to note that symptoms may not be immediately apparent; therefore, even in the absence of noticeable signs, medical evaluation is essential.

Prompt recognition and management of an overdose can significantly influence patient outcomes, underscoring the necessity for vigilance in monitoring dosage adherence.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Severe skin reactions have been reported in association with acetaminophen use, including 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, instances of overdose have been documented, which may lead to liver damage. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) promptly. Timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days. Similarly, if a fever worsens or lasts longer than 3 days, patients should stop using the product and consult a healthcare professional.

Patients should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition. Additionally, patients with liver disease should be advised to consult a doctor before using this medication. Those taking the blood-thinning medication warfarin should also seek medical advice prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in vials, and it is essential to store it at a temperature range of 59-86˚F (15-30˚C). Care should be taken to ensure that the vial remains sealed and undamaged; the product should not be used if the vial is open or shows any signs of damage.

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 Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)