Extra Strength Pain Relief

Description

This product is identified by the code 51945-4 and is associated with the package label principal display panel. The effective date of this labeling is May 9, 2013. The product is represented visually by an image file, referenced as 251.jpg, which is in JPEG format.

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 aged 12 years and older are instructed to take 2 gelcaps orally every 6 hours as needed, with a maximum dosage of 6 gelcaps within a 24-hour period. It is essential that this medication is not taken for more than 10 consecutive days unless directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage, as overdose may lead to liver damage. No other contraindications have been identified.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 8 gelcaps (4,000 mg of acetaminophen) within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must 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. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a healthcare professional. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should avoid its use. It is advisable for patients with liver disease to consult a physician prior to using this product. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider before use.

Patients should be instructed to discontinue use and consult a physician 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 occurs, as these may indicate a serious underlying condition. Pregnant or breastfeeding individuals should also seek professional advice before using this product.

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

If any skin reactions occur, patients must stop using the product and seek medical help immediately. Additionally, they should discontinue use and consult a healthcare professional if pain or fever worsens or persists beyond the specified durations, or if new symptoms or signs of redness or swelling develop.

Side Effects

Severe liver damage may occur in patients who exceed 8 gelcaps (4,000 mg of acetaminophen) within a 24-hour period, use this product in conjunction with other drugs containing acetaminophen, or consume 3 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are allergic to acetaminophen or any inactive ingredients in this product should also refrain from use. Prior to using this product, patients with liver disease should consult a healthcare professional. Additionally, those taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist before use.

Patients are advised to discontinue use and consult a healthcare provider 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 occurs, as these may indicate a serious condition.

In cases of overdose, which may result from exceeding the recommended dosage, patients should seek medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. If pregnant or breastfeeding, patients should consult a health professional before use.

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. Monitoring for signs of liver damage is advised in patients who may inadvertently exceed the recommended acetaminophen dosage.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Pain Relief (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 2 gelcaps every 6 hours as needed, with a maximum of 6 gelcaps in a 24-hour period. It is important to note that the medication should not be taken for more than 10 days unless directed by a healthcare provider. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

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 advice from a healthcare professional or pharmacist before initiating treatment. The interaction between this medication and warfarin may require dose adjustments or increased monitoring to ensure safety and efficacy.

In the event of an overdose, prompt medical attention is crucial for elderly patients, as well as for children. This highlights the importance of vigilance in recognizing overdose symptoms and seeking immediate care.

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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 8 gelcaps (4,000 mg of acetaminophen) within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Before initiating treatment, patients with liver disease are advised to consult a healthcare professional. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of the medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Prompt intervention can be vital in mitigating the risks associated with excessive dosing.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning 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 and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about the risks associated with overdose. It is important to communicate that taking more than the recommended dose may lead to liver damage. Patients should be informed that in the event of an overdose, they must seek medical help immediately or contact a Poison Control Center. Emphasize the urgency of obtaining quick medical attention for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is crucial for ensuring patient safety and preventing serious health complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20⁰C to 25⁰C (68⁰F to 77⁰F). Care should be taken to avoid exposure to high humidity, as this may affect the integrity of the product. Proper storage conditions are crucial to maintain the quality and efficacy of the product throughout its shelf life.

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 Extra Strength Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)