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 the common cold, headache, 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 over are instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum allowable dosage is 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. This medication should not be taken for more than 10 consecutive days.

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

Contraindications

Use of this product is contraindicated in the following situations:

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

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation, as this may lead to severe allergic reactions.

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 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use, as there may be potential interactions.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should also be instructed to discontinue use and consult a healthcare professional if they experience any of the following: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or any signs of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if patients exceed a dosage of 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. It is crucial for patients with liver disease to consult a healthcare professional prior to use.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for signs that may indicate a serious condition. They are instructed to stop use and consult a doctor 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.

Furthermore, patients taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist before using this product.

In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

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

No additional drug interactions or laboratory test interactions have been identified for acetaminophen. Therefore, routine monitoring or dosage adjustments are not specified beyond the aforementioned consideration with warfarin.

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 not use this medication without consulting a healthcare professional. For adolescents aged 12 years and older, the maximum recommended dosage is 6 caplets within a 24-hour period, unless otherwise directed by a physician.

In the event of an overdose, it is crucial to seek immediate medical attention for pediatric patients, even if they do not exhibit any signs or symptoms.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may impact the safety and efficacy of the treatment.

For adults and children aged 12 years and older, it is advised not to exceed a maximum of 6 caplets within a 24-hour period unless otherwise directed by a physician. Additionally, the duration of use should not exceed 10 days without medical supervision.

For children under 12 years of age, it is recommended to seek guidance from a healthcare professional before administration. These precautions are particularly important for geriatric patients, who may have altered pharmacokinetics and increased sensitivity to medications. Regular monitoring and appropriate dose adjustments may be necessary to ensure safety and effectiveness in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 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 for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

• Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the potential for liver damage.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any signs of hepatotoxicity early.

Overdosage

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 intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of liver disease should be encouraged to consult with their healthcare provider before using this medication. Furthermore, those who are taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25℃ (68-77℉), with permissible excursions between 15-30℃ (59-86℉). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

No further data are available.

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)