Qaulity Choice Pain Relief Extra Strength

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is also indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are advised to take 1 to 2 tablespoonfuls every 4 to 6 hours as needed. The total daily dosage should not exceed 6 tablespoonfuls within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

There are no specific contraindications listed for this product. However, 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 medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of liver damage if not used according to the specified guidelines. The maximum daily dose is limited to 6 tablespoonfuls (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 of acetaminophen) in 24 hours, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. 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 a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use.

Prior to using this product, patients should consult a healthcare provider if they have a history of liver disease or are currently taking the anticoagulant warfarin.

While using this product, it is crucial not to exceed the recommended dosage. Patients should be advised to discontinue use and seek medical advice if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent, as prompt intervention is critical for both adults and children.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe liver damage, which may occur if patients exceed 8 tablespoonfuls (4,000 mg of acetaminophen) in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Patients are advised to stop use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed. These symptoms may indicate the presence of a serious condition that requires medical evaluation.

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 Extra Strength (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 to 2 tablespoonfuls every 4 to 6 hours as needed, with a maximum of 6 tablespoonfuls in a 24-hour period. In the event of an overdose, it is critical to seek quick medical attention for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients 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 the dosage exceeds 8 tablespoonfuls (4,000 mg of acetaminophen) in a 24-hour timeframe.

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

Overdosage

In cases of overdosage, the maximum recommended daily dose of this product is 6 tablespoonfuls within a 24-hour period. Exceeding this dosage can lead to serious health consequences. Specifically, the risk of severe liver damage is significantly heightened if an individual ingests more than 8 tablespoonfuls, which equates to 4,000 mg of acetaminophen, within the same timeframe.

Healthcare professionals should be aware that the potential for severe liver damage is also increased when this product is taken concurrently with other medications that contain acetaminophen. Additionally, the risk is further compounded in individuals who consume three or more alcoholic beverages daily while using this product.

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Prompt evaluation and management are crucial to mitigate the risk of severe liver injury. Monitoring liver function and providing supportive care are essential components of the management strategy for affected individuals.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings available regarding 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 this medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. Patients should be informed that in the event of an overdose, they must seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential 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 crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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