Extra Strength Pain Reliever

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, talc, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

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 effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children 12 years of age and over are advised to take 1 to 2 caplets every 4 to 6 hours as needed. It is important not to exceed a total of 6 caplets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

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 for guidance.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of liver damage if not used according to the specified guidelines. The maximum recommended daily dose is 6 caplets within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 8 caplets (4,000 mg of acetaminophen) in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also trigger 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.

Healthcare professionals should advise patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

Patients with liver disease should seek medical advice prior to using this product. Additionally, those taking the anticoagulant warfarin should consult a healthcare professional before use to avoid potential interactions.

Patients are advised to discontinue use and consult a doctor if any of the following occur: pain worsens or persists for more than 10 days, 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.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should seek emergency medical help or contact a Poison Control Center without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of 8 caplets (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.

Additionally, patients are advised to stop use and consult 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 is observed. These symptoms may indicate the presence of a serious condition that requires medical evaluation.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength 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 1-2 caplets every 4-6 hours as needed, with a maximum of 6 caplets in a 24-hour period. In the event of an overdose, it is essential to seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

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 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose is limited to 6 caplets within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed the following limits:

• More than 8 caplets (4,000 mg of acetaminophen) in 24 hours.

• Concurrent use with other medications containing acetaminophen.

• Consumption of 3 or more alcoholic drinks daily while using this product.

Patients with liver disease are advised to consult a healthcare professional prior to use to assess the appropriateness of this product based on their liver function. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The absence of symptoms does not preclude the possibility of serious complications; therefore, thorough evaluation and monitoring are essential.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the imprinted seal under the cap is missing or broken.

For optimal storage, the product must be maintained at a temperature range of 20°C to 25°C (68°F to 77°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy 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. 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, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)