Pain Reliever

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before use and to utilize only the enclosed dosing cup specifically designed for this product; other dosing devices should not be used.

The recommended dosing intervals are as follows: if needed, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

The following dosage chart provides guidance for dosing:

• For patients weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

• For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb and aged 11 years, the recommended dose is 15 mL.

Dosing should be adjusted as necessary based on the patient's specific needs and in accordance with a physician's guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, the maximum daily amount, or concurrent use with other medications containing acetaminophen significantly increases the risk of liver injury.

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

In cases of severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

General precautions should be observed. Caregivers are advised to consult a physician prior to administration if the child has a history of liver disease. Additionally, it is prudent to seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, due to potential interactions.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days. These symptoms may indicate a serious condition requiring further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients are advised to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, and to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

There is also 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. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a doctor promptly.

It is recommended that patients ask a doctor before using this product if they have liver disease or are taking the blood-thinning medication warfarin.

While using this product, patients should adhere strictly to the recommended dosage to avoid overdose, which may result in liver damage. Patients should stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition.

In the case of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately, even if no signs or symptoms are present, as prompt medical attention is essential.

Drug Interactions

Acetaminophen may interact with the anticoagulant warfarin. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. This interaction may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and safety.

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 aged 2 to 11 years are indicated for use. The recommended dosing is based on weight and age as follows: for children under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for 72-95 lb (11 years), the dose is 15 mL. It is important not to exceed 5 doses in a 24-hour period and not to administer the medication for more than 5 days unless directed by a healthcare professional. When possible, dosing should be based on weight; otherwise, age may be used.

Warnings include a liver warning indicating that severe liver damage may occur if the child takes more than 5 doses in 24 hours or if used concurrently with other medications containing acetaminophen. An allergy alert is also present, as acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Additionally, a sore throat warning advises that if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Consultation with a healthcare professional is recommended before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, taking into account individual patient factors and overall health status. Monitoring for efficacy and safety is advised, as the absence of specific data does not preclude the need for careful assessment in elderly individuals.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for use in pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied. Therefore, caution is advised when considering the use of this product during lactation.

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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is important to note that exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential, even if the patient does not exhibit any signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. 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, even in the absence of noticeable signs or symptoms of overdose. Healthcare professionals should be aware that early recognition and management of overdose can significantly impact patient outcomes.

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 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 be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should instruct patients to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious underlying condition.

Patients should be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product.

For proper identification, the lot number and expiration date are located on the bottom panel of the packaging. Care should be taken to ensure that these details are accessible for reference.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

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)