Genexa 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 chewable tablet contains 80 mg of acetaminophen, the same active ingredient found in Children's Tylenol®. The product is presented in a grape flavor and is packaged in a bottle containing 24 chewable tablets. Genexa® is formulated without artificial additives, ensuring it is free from common allergens, artificial preservatives, flavors, and dyes.

Uses and Indications

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

For patients weighing under 24 lbs. or under 2 years of age, it is advised to consult a physician for the appropriate dosage. For patients weighing between 24-35 lbs. (ages 2-3 years), the recommended dose is 2 tablets. For those weighing 36-47 lbs. (ages 4-5 years), the dose increases to 3 tablets. Patients weighing 48-59 lbs. (ages 6-8 years) should receive 4 tablets, while those weighing 60-71 lbs. (ages 9-10 years) should be administered 5 tablets. Finally, for patients weighing 72-95 lbs. (ages 11 years), the recommended dose is 6 tablets.

Tablets must be chewed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. In all cases, if there is uncertainty regarding the appropriate dosage, consultation with a healthcare provider is recommended.

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.

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

• Exceeding the recommended dosage while using this product is contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted if the product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken when administering this product. It is advisable to consult a physician prior to use if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In cases of suspected overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, regardless of whether symptoms are present, as prompt intervention is essential for both adults and children.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which may vary in seriousness and frequency.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are at increased risk if they exceed five doses within a 24-hour period, which is the maximum recommended daily amount, or if they concurrently use other medications containing acetaminophen.

Additionally, there is an allergy alert regarding the potential for severe skin reactions. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms related to sore throat. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Furthermore, patients are instructed to stop use and consult a doctor if any of the following occur: pain worsens or lasts longer than five days, fever worsens or lasts longer than three days, new symptoms arise, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 Genexa Kids Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 lbs. (under 2 years) should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lbs., the recommended dosage is 2 tablets. For those aged 4 to 5 years weighing 36-47 lbs., the dosage increases to 3 tablets. Children aged 6 to 8 years weighing 48-59 lbs. should take 4 tablets, while those aged 9 to 10 years weighing 60-71 lbs. can take 5 tablets. For children weighing 72-95 lbs. at 11 years of age, the dosage is 6 tablets.

Healthcare professionals should be aware of several warnings associated with use in pediatric patients. Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount when combined with other drugs containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical help should be sought. A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a doctor.

It is advised to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance tailored to geriatric populations. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for elderly patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits of administering this product to geriatric patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of elderly patients receiving this treatment.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus have not been fully evaluated; therefore, acetaminophen should only be used if clearly needed and if the benefits outweigh the risks.

Dosage adjustments may be necessary, and healthcare providers should be consulted for guidance on appropriate dosing. Special precautions should be taken to monitor for any adverse effects during pregnancy. If any unusual symptoms occur, the use of acetaminophen should be discontinued, and a healthcare provider should be consulted promptly.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 may be warranted to ensure safety and efficacy in this 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 for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that all cases of suspected overdose be treated as medical emergencies, necessitating thorough evaluation and appropriate therapeutic measures.

Monitoring and supportive care may be required, depending on the specific circumstances and clinical presentation of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately, and medical assistance should be sought without delay.

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 product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, as outlined in the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before using this product 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 packaging that ensures its integrity during storage. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to high humidity, which may compromise the product's quality. Additionally, it is essential to protect the product from light to prevent any potential degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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