Kids Pain and Fever

Description

Genexa® is a clean medicine formulation designed for children aged 2 to 11 years, specifically for the relief of pain and reduction of fever. Each 5 mL dose of the oral suspension contains 160 mg of acetaminophen, the same active ingredient found in Children’s Tylenol®. The product is free from artificial additives, preservatives, flavors, and dyes, ensuring it is always devoid of common allergens. Genexa® is available in a cherry flavor and is packaged in two 4 FL OZ (118 mL) bottles, providing a total volume of 8 FL OZ (236 mL).

Uses and Indications

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

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

Dosage and Administration

Shake the product well before each use. For accurate dosing, healthcare professionals should refer to the dosage chart provided below. It is essential to use the measuring cup included with the product for dosing; other dosing devices should not be utilized to ensure accuracy.

Dosing should be administered every 4 hours as needed while symptoms persist. If possible, weight should be used to determine the appropriate dose; if weight is not available, age may be used as a secondary guide. It is important to note that no more than 5 doses should be given within a 24-hour period.

Dosage Chart:

• For patients under 24 lbs. (under 2 years), consultation with a doctor is advised.

• For patients weighing 24-35 lbs. (2-3 years), the recommended dose is 5 mL.

• For patients weighing 36-47 lbs. (4-5 years), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lbs. (6-8 years), the recommended dose is 10 mL.

• For patients weighing 60-71 lbs. (9-10 years), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lbs. (11 years), the recommended dose is 15 mL.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related toxicity. 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 in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen may also lead to severe skin reactions, which can 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 severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Before administering this product, it is essential to inquire about the child's medical history. Specifically, consultation with a healthcare provider is recommended if the child has a history of liver disease. Additionally, if the child is currently taking the anticoagulant warfarin, it is advisable to seek guidance from a doctor or pharmacist prior to use.

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

Parents should also be instructed to discontinue use and consult a healthcare professional if the child's pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, 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.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should stop use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor before use if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to using this product.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. 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 Kids Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not exceed the recommended dosage as outlined in the Overdose warning. For accurate dosing, the measuring cup provided should be utilized, and no other dosing device should be employed. Dosing should occur every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

For optimal dosing, weight should be used when available; otherwise, age may be considered. The recommended doses based on weight and age are as follows:

• For patients under 24 lbs. and under 2 years of age, consultation with a doctor is advised.

• For patients weighing 24-35 lbs. (2-3 years): 5 mL.

• For patients weighing 36-47 lbs. (4-5 years): 7.5 mL.

• For patients weighing 48-59 lbs. (6-8 years): 10 mL.

• For patients weighing 60-71 lbs. (9-10 years): 12.5 mL.

• For patients weighing 72-95 lbs. (11 years): 15 mL.

Healthcare professionals should advise parents to consult a doctor before use if the child has liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is concurrently taking the blood-thinning medication warfarin.

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending acetaminophen to women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its effects on fetal outcomes.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant 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 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 essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

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 intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with 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. 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 keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be instructed to stop using the medication and seek medical advice if they experience any of the following: if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

Additionally, healthcare providers should recommend that patients consult a doctor before using this medication if their child has liver disease. It is also essential to advise patients to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin, as there may be potential interactions that need to be managed.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)