Qaulity Choice Pain Relief Regular Strength

Description

Acetaminophen, commonly referred to as APAP, is a non-opioid analgesic and antipyretic agent. It is characterized by its chemical formula C8H9NO2 and has a molecular weight of 151.16 g/mol. Acetaminophen is typically presented in various dosage forms, including tablets, capsules, and liquid formulations. The compound appears as a white, crystalline powder that is soluble in water and alcohol. Inactive ingredients may vary depending on the specific formulation.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, 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

The recommended dosage should not exceed the directed amount. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight or age.

For optimal dosing, weight should be used when possible; if weight is not available, age may be utilized. Dosing may be repeated every 4 hours as needed, or as directed by a physician. A maximum of 5 doses should not be administered within a 24-hour period.

Dosage Chart:

Weight (lbs)

• Under 24: Consult physician

• 24-35: 1 teaspoon (5 mL)

• 36-47: 1 1/2 teaspoons (7.5 mL)

• 48-59: 2 teaspoons (10 mL)

• 60-71: 2 1/2 teaspoons (12.5 mL)

• 72-95: 3 teaspoons (15 mL)

• Over 95: 4 teaspoons (20 mL)

Age (years)

• Under 2: Consult physician

• 2 to 3: 1 teaspoon (5 mL)

• 4 to 5: 1 1/2 teaspoons (7.5 mL)

• 6 to 8: 2 teaspoons (10 mL)

• 9 to 10: 2 1/2 teaspoons (12.5 mL)

• 11: 3 teaspoons (15 mL)

• 12 to adult: 4 teaspoons (20 mL)

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. The maximum recommended daily dose is 6 tablespoonfuls (equivalent to 3,000 mg of acetaminophen) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 8 tablespoonfuls (4,000 mg) in 24 hours, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Drug Interactions This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. Healthcare professionals should advise patients to consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this formulation should refrain from use.

General Precautions Patients should consult a healthcare provider prior to using this product if they have a history of liver disease or are currently taking the anticoagulant warfarin. It is crucial to adhere strictly to the recommended dosage to mitigate risks.

Monitoring and Follow-Up Patients are advised to discontinue use and contact a healthcare professional 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 occurs, as these may indicate a serious underlying condition.

Emergency Situations In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent. Prompt intervention is critical for both adults and children.

Side Effects

Patients may experience serious adverse reactions associated with the use of this product. A significant warning pertains to the potential for severe liver damage, which may occur if patients exceed 8 tablespoonfuls (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.

Additionally, there is an allergy alert indicating that acetaminophen may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription.

It is recommended that patients stop use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

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 Qaulity Choice Pain Relief Regular Strength (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric use is indicated for children under 12 years of age. Dosage should be determined based on weight whenever possible; if weight is not available, age may be used as a guide.

For children under 2 years, consultation with a physician is recommended. The following age-based dosages are advised:

• 2 to 3 years: 1 teaspoonful (5 mL)

• 4 to 5 years: 1 1/2 teaspoonfuls (7.5 mL)

• 6 to 8 years: 2 teaspoonfuls (10 mL)

• 9 to 10 years: 2 1/2 teaspoonfuls (12.5 mL)

• 11 years: 3 teaspoonfuls (15 mL)

• 12 years to adult: 4 teaspoonfuls (20 mL)

Dosage may be repeated every 4 hours, or as directed by a healthcare provider, with a maximum of 5 doses in a 24-hour period. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is critical for both adults and children, even if no symptoms are present.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of liver disease. The potential for altered drug metabolism in this population necessitates careful consideration and monitoring.

Additionally, geriatric patients who are concurrently taking the anticoagulant warfarin must seek medical advice before initiating treatment with this medication. The interaction between these drugs may require dose adjustments or increased monitoring to ensure safety and efficacy.

It is crucial for healthcare providers to emphasize the importance of seeking quick medical attention for elderly patients, even in the absence of noticeable signs or symptoms. Prompt intervention can be critical in managing potential adverse effects or complications associated with the use of this medication in the geriatric population.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose is 6 tablespoonfuls within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 8 tablespoonfuls (4,000 mg of acetaminophen) in 24 hours, particularly when combined with other medications containing acetaminophen or when consuming 3 or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects associated with acetaminophen use.

Overdosage

In cases of overdosage, it is critical to adhere to the recommended maximum daily dose of this product, which is 6 tablespoonfuls within a 24-hour period. Exceeding this dosage can lead to serious health consequences.

Potential Symptoms of Overdosage Taking more than 8 tablespoonfuls (equivalent to 4,000 mg of acetaminophen) within a 24-hour timeframe may result in severe liver damage. Additionally, the risk of liver damage is heightened when this product is used concurrently with other medications that contain acetaminophen.

Furthermore, individuals who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage.

Management Procedures Healthcare professionals should monitor patients for signs of liver injury and provide appropriate interventions. In cases of suspected overdosage, immediate medical attention is warranted. It is essential to assess the patient's history of acetaminophen intake and alcohol consumption to determine the appropriate course of action.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a health professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and 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 the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the seriousness of an overdose situation. Patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222 in the event of an overdose. Quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with the dosage potentially repeatable every 4 hours or as directed by a healthcare professional. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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