Kids Pain and Fever

Description

Genexa® is a clean medicine formulation designed for children aged 2 to 11 years, specifically indicated 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. The oral suspension is presented in a 4 fl oz (118 mL) bottle and features a blueberry flavor.

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 below and utilize the measuring cup provided. It is imperative not to use any other dosing device to ensure precision.

Dosing should be administered every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period. When determining the appropriate dose, it is recommended to use the patient's weight; if weight is not available, age may be used as an alternative.

Dosage Chart:

• For patients weighing under 24 lbs. or under 2 years of age, consult a physician for the appropriate dose.

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

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

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

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

• For patients weighing 72-95 lbs. (11 years of age), 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. This is due to the potential risk of acetaminophen overdose, which can lead to severe 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 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.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product. Additionally, it is essential to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 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

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 with liver disease should consult a doctor before use.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to stop use immediately and seek medical assistance.

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

Patients should discontinue use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Additionally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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

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 be dosed carefully according to weight and age to ensure safety and efficacy. For accurate dosing, the measuring cup provided should be used; other dosing devices are not recommended. Doses may be administered every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period.

For patients under 24 lbs (under 2 years), consultation with a doctor is advised before administration. For those weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. Patients weighing 36-47 lbs (ages 4-5 years) should receive 7.5 mL, while those weighing 48-59 lbs (ages 6-8 years) should be given 10 mL. For patients weighing 60-71 lbs (ages 9-10 years), the dose is 12.5 mL, and for those weighing 72-95 lbs (11 years), the recommended dose is 15 mL.

It is crucial not to exceed the directed dosage to avoid the risk of overdose.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

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 consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of acetaminophen during pregnancy. It is advisable to exercise caution and to discuss any medication use with a healthcare provider.

Lactation

Lactating 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 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 of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary 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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen. Reported symptoms may include 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 be sought.

Patient Counseling

Healthcare providers should advise patients to keep the 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 with 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: worsening pain that lasts more than 5 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of 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 controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. 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)