Pain Reliever, Caseys 4good

Description

Acetaminophen is a non-opioid analgesic and antipyretic agent, available in a dosage form of 500 mg per tablet. Each package contains a total of 6 tablets. Acetaminophen is indicated for the relief of pain and the reduction of fever.

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 over 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, 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

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as there may be potential interactions.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is vital for both adults and children.

Patients should also be instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening pain that persists beyond 10 days, fever that worsens or lasts more than 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 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 its use.

Patients are advised to stop using the product and consult a healthcare provider if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms develop, 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 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.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever, Caseys 4good (acetaminophen 500 mg, tablet). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. For children aged 12 years and older, the recommended dosage is 2 tablets every 6 hours while symptoms persist, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a healthcare professional. The product should not be used for more than 10 days unless advised by a doctor.

In cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent. It is important to keep this product out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed a dosage of 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.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product. In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this product.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health consequences.

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. Prompt intervention is essential, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with liver damage and to ensure appropriate care is provided.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can 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

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 about the presence of acetaminophen in other medications, 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 contained 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, 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.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use 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 a temperature range of 59-86˚F (15-30˚C) to maintain its efficacy and integrity. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets orally every 6 hours while symptoms persist, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a healthcare professional. The use of this medication should not exceed 10 days unless specifically instructed by a doctor.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, patients with liver disease or those taking the anticoagulant warfarin should seek medical advice before using this medication.

Drug Information (PDF)

This file contains official product information for Pain Reliever, Caseys 4good, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)