Pain Reliever

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, the common cold, 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 instructed to take 2 gelcaps orally every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 gelcaps within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, the duration of use should not exceed 10 days unless advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional before administration.

Patients are advised to adhere strictly to the recommended dosages and to avoid exceeding the specified limits.

Contraindications

Use of this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, concurrent use with any other medication that contains acetaminophen, whether prescription or nonprescription, is contraindicated 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.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the risk of liver damage increases with the following conditions: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

General precautions should be taken into account prior to use. Patients with a history of liver disease should consult a healthcare provider before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as interactions may occur.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no immediate signs or symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain lasting more than 10 days, fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with acetaminophen.

Severe liver damage is a significant concern, particularly if patients exceed 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 associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients contained within. It is also contraindicated for use with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a healthcare professional.

Before using this product, patients with liver disease should consult a doctor. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Patients are advised to stop using the product and consult a doctor 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

Acetaminophen has been shown to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding complications. When these two agents are co-administered, it is recommended to monitor the International Normalized Ratio (INR) closely to ensure safe therapeutic levels are maintained.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of 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 2 gelcaps every 6 hours as needed, with a maximum of 6 gelcaps in a 24-hour period, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information 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 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

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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. It is also important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescribed or over-the-counter. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days. Additionally, patients should be advised to stop use and seek medical advice if they experience new symptoms or notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which can be referenced for identification. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF and 86ºF). Care should be taken to avoid exposure to high humidity, as this may affect the product's integrity. For tracking purposes, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)