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 older are advised to take 30 mL every 6 hours as needed while symptoms persist. It is imperative not to exceed 4 doses within a 24-hour period. The maximum duration of use is 10 days, unless otherwise directed by a healthcare professional.

For accurate dosing, the provided dosing cup must be used; no other dosing devices should be employed. The dosing cup should be kept with the product to ensure proper measurement.

Children under 12 years of age should not use this medication. It is essential to adhere strictly to these guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

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 is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should exercise caution and recommend that patients consult a physician prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should be advised to consult with a doctor or pharmacist before using this product, as interactions may occur.

In cases of overdose, it is imperative to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: worsening pain that persists beyond 10 days, fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence 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 4,000 mg of acetaminophen within a 24-hour period, combine this product with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In the event of an overdose, which is defined as taking more than the recommended dose, patients may experience liver damage. Immediate medical attention is crucial in cases of overdose, and patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent.

Patients should also be vigilant for signs of severe skin reactions, which may include skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical assistance promptly.

Additionally, patients are advised to stop using the product 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, as these may indicate a serious underlying condition.

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 interaction between acetaminophen and warfarin may necessitate careful monitoring of INR levels, as acetaminophen has the potential to affect the anticoagulant effect of warfarin.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen.

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. For adolescents aged 12 years and older, the recommended dosage is 30 mL every 6 hours while symptoms persist, with a maximum duration of use not exceeding 10 days unless directed by a healthcare professional.

In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 6 hours while symptoms persist, with a maximum duration of use not exceeding 10 days unless directed by a healthcare professional. Careful monitoring is recommended in elderly patients to ensure adherence to these guidelines and to assess for any adverse effects or complications that may arise during treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential for both adults and children, regardless of the presence of symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance. Healthcare professionals should monitor for any signs of liver impairment and be prepared to initiate appropriate management protocols.

Management Procedures Upon confirmation of an overdose, healthcare providers should follow established clinical guidelines for the assessment and treatment of liver toxicity. This may include supportive care and monitoring of liver function tests, as well as considering the need for further interventions based on the severity of the overdose.

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 that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately 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 signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever worsens or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also remind patients to seek medical advice before using this medication if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should be advised to consult with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20-25ºC (68-77ºF) and must not be refrigerated. Additionally, it is essential to protect the product from light to maintain its integrity and effectiveness.

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

View product document (PDF)