Pain Relief Extra Strength

Description

Acetaminophen Capsules contain 500 mg of acetaminophen per capsule. The product is supplied in a bulk quantity of 3000 capsules, with the National Drug Code (NDC) number 53345-019-01. It is essential to inspect the shipment immediately upon receipt. This product is intended solely for further manufacturing, processing, or repacking. Proper storage conditions must be maintained; the capsules should be protected from heat, humidity, and light, and refrigeration is not recommended.

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 12 years of age and over are advised to take 2 softgels every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 softgels within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, the duration of use should not exceed 10 days unless specifically instructed 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:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a history of allergic reactions to this product or any of its components.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. The maximum recommended daily dose is 6 softgels (3,000 mg) within a 24-hour period. Healthcare professionals should advise patients to avoid exceeding 4,000 mg of acetaminophen in 24 hours, using this product in conjunction with other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while taking this product.

Patients with liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as interactions may occur.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening pain lasting more than 10 days, fever persisting 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 medical evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly concerning liver health. The product contains acetaminophen, and exceeding the maximum daily dose of 6 softgels (3,000 mg) within 24 hours may lead to severe liver damage. This risk is heightened if patients take more than 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients are advised not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should refrain from its use.

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

Patients should discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious condition requiring medical attention.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Children 12 years of age and older should consult a healthcare professional before use. For adults and pediatric patients aged 12 years and older, the recommended dosage is 2 softgels every 4 to 6 hours as needed for symptom relief. It is important not to exceed 6 softgels within a 24-hour period unless directed by a healthcare provider. Additionally, the duration of use should not exceed 10 days unless advised by a doctor.

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 medication. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, 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 softgels every 4 to 6 hours as needed for symptom relief, with a maximum of 6 softgels in a 24-hour period unless otherwise directed by a healthcare professional. It is important to note that the use of this medication should not exceed 10 days unless specifically instructed by a doctor, to minimize the risk of adverse effects and ensure appropriate monitoring of the patient's condition.

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 breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum daily dose of this product is 6 softgels (3,000 mg) within a 24-hour period. It is critical to note that exceeding 4,000 mg of acetaminophen in 24 hours, using other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may significantly increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

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 adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No teratogenic effects have been observed in the studies conducted. Additionally, there are no reported non-teratogenic effects. The available data does not provide any specific details regarding nonclinical toxicology. Furthermore, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted in patients taking acetaminophen, particularly among those who exceed the recommended dosage or have underlying liver disease. Instances of allergic reactions, including anaphylaxis, have also been documented following the use of acetaminophen. Furthermore, renal impairment has been associated with acetaminophen use, especially in patients with pre-existing kidney conditions.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this product if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a temperature range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

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

Drug Information (PDF)

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

View product document (PDF)