Pain Relief

Description

NDC 11822-9440-8. This product contains acetaminophen 160 mg in chewable tablet form, specifically formulated for children aged 2 to 11 years. It serves as a pain reliever and fever reducer, and is available in a grape flavor. Each package contains 24 chewable tablets, which should be chewed or crushed completely before swallowing. The formulation does not include aspirin or ibuprofen. The product is tamper evident; do not use if the imprinted safety seal under the cap is broken or missing. Distributed by Rite Aid, 200 Newberry Commons, Etters, PA 17319, www.riteaid.com. This product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Children's Tylenol®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

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 adhere to the following guidelines:

• The recommended dosing intervals are every 4 hours as needed while symptoms persist. However, the total number of doses should not exceed 5 doses within a 24-hour period.

• Treatment should not extend beyond 5 consecutive days unless directed by a physician.

For administration, the tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, consultation with a doctor is required.

• For patients weighing 24-35 lb (2-3 years): administer 1 chewable tablet.

• For patients weighing 36-47 lb (4-5 years): administer 1 ½ chewable tablets.

• For patients weighing 48-59 lb (6-8 years): administer 2 chewable tablets.

• For patients weighing 60-71 lb (9-10 years): administer 2 ½ chewable tablets.

• For patients weighing 72-95 lb (11 years): administer 3 chewable tablets.

It is crucial to ensure that the dosage does not exceed the specified limits and to monitor the patient for any adverse effects during treatment.

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 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 should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this 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, if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Acetaminophen has been associated with 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.

Healthcare providers should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be observed, particularly in patients with pre-existing conditions. It is advisable to consult a physician before administering this product to children with liver disease. Furthermore, healthcare professionals should inquire about the use of anticoagulants, such as warfarin, as interactions may occur.

In cases of overdose, immediate medical attention is critical. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than five days, worsening fever lasting more than three days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires 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 it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of 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.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised against using this product if they are currently taking any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it should not be used by individuals who are allergic to acetaminophen or any of the inactive ingredients in the formulation.

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

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a healthcare provider if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is indicated for pediatric patients aged 2 to 11 years. Dosage varies by age and weight: for children under 24 lb (under 2 years), consultation with a doctor is advised. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet; for 36-47 lb (ages 4-5 years), 1 1/2 tablets; for 48-59 lb (ages 6-8 years), 2 tablets; for 60-71 lb (ages 9-10 years), 2 1/2 tablets; and for 72-95 lb (age 11 years), 3 tablets.

The maximum dosage should not exceed 5 doses in a 24-hour period, and the product should not be administered for more than 5 days unless directed by a healthcare professional. Caution is advised as severe liver damage may occur if the recommended dosage is exceeded.

Healthcare providers should consult a doctor if the pediatric patient has liver disease or is taking the anticoagulant warfarin. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash; if such reactions occur, use should be discontinued immediately, and medical assistance sought.

Parents and caregivers should also be aware that if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is necessary.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no dedicated information regarding geriatric use is provided in the prescribing information. The product is indicated for pediatric patients aged 2 to 11 years, and there are no dosage adjustments or safety concerns outlined for geriatric patients.

Healthcare providers should exercise caution when considering the use of this product in elderly patients, given the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects may be warranted, as the absence of specific geriatric data necessitates a careful assessment of individual patient needs and responses.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of comprehensive data, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are carefully considered.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in individuals with compromised liver function.

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, 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, it is essential to monitor the patient closely and provide appropriate care as needed.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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 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. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. This is important to prevent potential adverse effects and ensure safe usage.

Additionally, healthcare providers should encourage patients to consult with a doctor before administering the medication to a child who has liver disease. This precaution is vital to avoid complications related to liver function.

Furthermore, it is essential for patients to discuss any concurrent use of the blood-thinning medication warfarin with their doctor or pharmacist prior to using this medication. This discussion will help to manage any potential interactions and ensure the safety of the treatment plan.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). Care should be taken to avoid exposure to high humidity, which 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, with specific instructions for patients to chew or crush the tablets completely before swallowing, as whole tablets should not be swallowed. Dosing can be repeated every 4 hours while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)