Pain Reliever

Description

H-E-B® Children's Pain Reliever contains acetaminophen as its active ingredient, with a dosage of 160 mg per chewable tablet. This formulation is designed for children aged 2 to 11 years and serves as a pain reliever and fever reducer. The product is available in a chewable tablet form, with a total of 24 tablets per package, and features a bubblegum flavor. It is free from ibuprofen and aspirin.

The tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. The product is packaged with a tamper-evident seal, and it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. The National Drug Code (NDC) for this product is 37808-945-08. It is important to note that this product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Children’s Tylenol® Chewables.

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 specific dosing should be determined based on the patient's weight or age. Healthcare professionals are advised to refer to the following dosage chart to identify the appropriate dose:

• For patients weighing under 24 lb or under 2 years of age, consult a physician for dosing recommendations.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 chewable tablet.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1 ½ chewable tablets.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 chewable tablets.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2 ½ chewable tablets.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 chewable tablets.

Patients should chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. It is imperative to adhere to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

The use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This precaution is necessary to avoid the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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, caregivers should be aware that administering more than five doses within a 24-hour period or combining this product with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise parents to consult a physician if their child experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Prompt medical evaluation is essential in these cases.

Before administering this product, it is crucial to inquire about any pre-existing liver conditions. Additionally, consultation with a healthcare provider or pharmacist is recommended if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the case of an overdose, immediate medical attention is necessary. Caregivers should contact a Poison Control Center or seek emergency medical help without delay, as timely intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening pain that lasts more than five days, a fever that worsens or persists for more than three days, the presence of redness or swelling, or the emergence of any new symptoms.

Side Effects

Severe liver damage may occur in patients taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they use it concurrently with other medications containing acetaminophen. Patients should be aware of the potential for 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.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay.

It is advised that patients stop use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if redness or swelling occurs, or if any new symptoms arise.

Additionally, patients should seek medical advice prior to use if they have liver disease or if they are taking the anticoagulant warfarin. In cases of overdose, immediate medical attention is crucial; patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is essential 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 may arise from unintentional duplication of therapy. 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 Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with specific dosing guidelines based on weight. For children under 24 lb (under 2 years), consultation with a doctor is advised prior to use. The recommended dosages for children aged 2 to 11 years are as follows:

• 24-35 lb (2-3 years): 1 tablet

• 36-47 lb (4-5 years): 1 1/2 tablets

• 48-59 lb (6-8 years): 2 tablets

• 60-71 lb (9-10 years): 2 1/2 tablets

• 72-95 lb (11 years): 3 tablets

It is important not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional. Prior to administration, healthcare providers should be consulted if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin.

As with all medications, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. 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 during pregnancy. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen to weigh the potential risks and benefits.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

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 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 safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

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 these contexts.

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 initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any other medications they are taking, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, patients should be advised to stop using the medication and seek medical advice if their fever intensifies or lasts longer than three days. Additionally, patients should be cautioned to stop use and contact a doctor if they notice any redness or swelling, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident package. It is imperative that the product not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to avoid high humidity during storage.

For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with tablets needing to be chewed or crushed completely before swallowing. Dosing can be repeated every 4 hours as long as symptoms persist, but should not 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.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no signs or symptoms are initially apparent.

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)