Pain Relief

Description

CareOne® Regular Strength Acetaminophen is formulated to provide effective pain relief and fever reduction. Each tablet contains 325 mg of acetaminophen, the active ingredient comparable to that found in Tylenol® Regular Strength Tablets. This product is aspirin-free, making it suitable for individuals who may be sensitive to aspirin. The product is available in a bottle containing 100 tablets, ensuring a sufficient supply for managing pain and fever. The National Drug Code (NDC) for this formulation is 41520-606-02.

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 advised to take 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets within a 24-hour period. Continuous use beyond 10 days is not recommended unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms last. The total daily intake should not surpass 5 tablets within a 24-hour period. Prolonged use beyond 5 days is not advised unless instructed by a physician.

For children under 6 years of age, it is essential to consult a doctor for appropriate dosing recommendations.

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.

• The product should not be used 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 poses a risk of severe liver damage under certain conditions. Healthcare professionals should be aware of the following critical warnings:

Liver Damage Risk Severe liver damage may occur if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period. For children, exceeding 5 doses in 24 hours, which is the maximum daily amount, can also lead to serious harm. Additionally, the risk increases if acetaminophen is taken concurrently with other medications containing acetaminophen. Adults who consume three or more alcoholic drinks daily while using this product are at heightened risk for liver damage.

Severe Skin Reactions Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Prior to use, it is advisable for individuals with liver disease to consult a healthcare provider. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Users should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Discontinuation and Consultation Users should stop taking this product and consult a healthcare professional if any of the following occur:

• Pain worsens or persists for more than 10 days in adults.

• Pain worsens or lasts more than 5 days in children under 12 years.

• Fever worsens or lasts more than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, or if a child exceeds 5 doses in the same timeframe, which is the maximum daily amount. The risk of liver damage is further heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

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

Acetaminophen should not be used concurrently 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 known allergies to acetaminophen or any inactive ingredients in the product should refrain from use.

Patients are advised to stop using the product and consult a healthcare provider if pain worsens or persists beyond 10 days in adults, or beyond 5 days in children under 12 years. Similarly, if fever worsens or lasts more than 3 days, or if new symptoms arise, including redness or swelling, medical advice should be sought, as these may indicate a serious condition.

It is recommended that patients consult a healthcare professional prior to use if they have liver disease or are taking the anticoagulant warfarin, as interactions may occur.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is critical for both adults and children.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this product. The interaction between this product 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 either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may take 2 tablets every 4 to 6 hours as needed for symptom relief, with a maximum of 10 tablets in a 24-hour period. Use should not exceed 10 days unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist, with a maximum of 5 tablets in a 24-hour period. This age group should not use the medication for more than 5 days unless advised by a doctor.

For children under 6 years, it is advised to consult a healthcare professional before use.

Healthcare providers should be aware that if pain worsens or persists for more than 5 days in children under 12 years, or if fever worsens or lasts more than 3 days, these may indicate a serious condition requiring further evaluation.

In cases of overdose, prompt medical attention is essential for pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 no specific data available regarding the excretion of this medication in 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage under certain conditions.

For adults, it is critical to adhere to a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. In pediatric patients, the maximum daily dosage should not exceed 5 doses within the same timeframe. Additionally, caution is advised when this product is used concurrently with other medications that contain acetaminophen, as this may lead to unintentional overdose.

Patients with compromised liver function who consume three or more alcoholic beverages daily should avoid using this product, as the combination may significantly increase the risk of liver injury. Regular monitoring of liver function may be warranted in patients with hepatic impairment who require acetaminophen, and healthcare providers should evaluate the risks versus benefits of continued use in these individuals.

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 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 health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years of age. Additionally, patients should be advised to stop use and consult a doctor if their fever worsens or lasts more than 3 days, if new symptoms arise, 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. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a carton that should be retained for complete product information. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity 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 further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)