Circle K Pain Reliever

Description

Acetaminophen is a pain reliever and fever reducer, available in an extra strength formulation. Each tablet contains 500 mg of acetaminophen. The product is packaged in pouches, with each pouch containing 2 tablets. A total of 6 tablets are provided across 3 pouches.

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:

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

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Warnings and Precautions

This product contains acetaminophen, and it is crucial 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 other medications that contain acetaminophen concurrently, or consuming 3 or more alcoholic drinks daily while using this product may lead to severe liver damage.

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

Overdose Warning Taking more than the recommended dosage can result in liver damage. In the event of an overdose, it is essential to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease or are currently taking the anticoagulant warfarin.

Monitoring and Follow-Up Patients should be instructed to stop using the product and consult a healthcare provider 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 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 doctor if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, 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 ensure therapeutic efficacy and minimize the risk of adverse effects. 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 Circle K Pain Reliever (acetaminophen). 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 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 affect 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.

It is important for elderly patients to adhere to the recommended dosage guidelines, which stipulate that no more than 6 tablets should be taken within a 24-hour period unless otherwise directed by a healthcare professional. Furthermore, the use of this medication should not exceed 10 days unless specifically instructed by a doctor, to mitigate 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use. It is important to note that exceeding the recommended dosage may lead to liver damage. Specifically, severe liver damage can occur if a patient ingests more than 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of severe liver damage increases if acetaminophen is taken concurrently with other medications that contain acetaminophen.

Patients who consume three or more alcoholic beverages daily while using this product are also at an elevated risk for severe liver damage. Therefore, careful consideration and monitoring of liver function are advised for patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose 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, individuals should 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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, 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.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

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, cases of overdose have been documented, which may lead to liver damage. It is crucial for individuals who suspect an overdose to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention 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. 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 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 known allergy to acetaminophen or any of the inactive ingredients included in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever intensifies 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.

It is also essential for healthcare providers to recommend that patients consult a doctor before using this medication if they have liver disease or if they are currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a secure packaging format, and it is imperative that it not be used if the inner pouch or carton is open or damaged. For optimal preservation, the product should be stored at room temperature, specifically within the range of 59-86˚F (15-30˚C). Healthcare professionals are advised to refer to the bottom panel of the packaging for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets every 6 hours while symptoms persist, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a physician. The use of the medication should not exceed 10 days unless specifically instructed by a healthcare provider. For children under 12 years, consultation with a doctor is recommended prior to use.

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

Drug Information (PDF)

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

View product document (PDF)