Pain Relief

Description

The product is identified by NDC 63868-082-10 and is marketed under the brand name QUALITY CHOICE. It is formulated as a regular strength pain reliever and fever reducer, containing acetaminophen as the active ingredient at a dosage of 325 mg per tablet. Each bottle contains 100 tablets, with each tablet delivering 325 mg of acetaminophen. This formulation is comparable to the active ingredient found in TYLENOL® Regular Strength Tablets.

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 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 should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

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:

Warnings Regarding Acetaminophen Use Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period. For children, administering more than 5 doses in a 24-hour timeframe, which constitutes the maximum daily amount, can also lead to serious harm. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen. It is imperative to advise adults who consume three or more alcoholic drinks daily to avoid using this product, as this significantly heightens the risk of liver injury.

General Precautions Prior to use, it is essential to consult a healthcare provider if the user has a history of liver disease. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as potential interactions may occur.

Emergency Medical Assistance In the event of an overdose, immediate medical assistance is crucial. Users should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay. This is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Users should discontinue use and consult a healthcare professional if any of the following occur: pain worsens or persists for more than 10 days in adults, pain lasts more than 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the recommended dosages. Specifically, adults should not take more than 4,000 mg of acetaminophen in a 24-hour period, while children should not exceed 5 doses within the same timeframe, which is the maximum daily amount. The risk of liver damage is further increased if 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 not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is advised to consult a doctor before use if the patient has liver disease or is taking the blood-thinning medication warfarin.

Patients are instructed to discontinue use and seek medical advice 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 arise, or if redness or swelling is observed. These symptoms may indicate a serious condition.

In the event of an overdose, it is critical for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

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 under 6 years of age should consult a doctor before use. For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours as needed, with a maximum of 5 tablets in a 24-hour period. This age group should not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

In contrast, adults and children aged 12 years and older may take 2 tablets every 4 to 6 hours while symptoms persist, with a maximum of 10 tablets in a 24-hour period. This group should not exceed 10 days of use unless advised by a doctor.

It is important to note 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, medical attention should be sought.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of liver disease, as this may impact the safety and efficacy of the treatment.

In the event of an overdose, it is crucial for elderly patients to seek immediate medical attention. Prompt intervention is essential for both adults and children to mitigate potential adverse effects associated with overdose. Careful monitoring and appropriate dose adjustments may be necessary to ensure the safety of geriatric patients during treatment.

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 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. Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period, a child takes more than 5 doses in 24 hours (the maximum daily amount), the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use to assess the appropriateness of this product and to discuss potential risks associated with acetaminophen. Monitoring of liver function may be warranted in these patients to prevent 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 intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely administration of appropriate medical care can significantly influence the outcome of an overdose situation. Therefore, vigilance and swift action are crucial components in the management of potential overdose cases.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

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 experiences.

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)