Genexa Infants Pain and Fever

Description

Genexa® Infants' Pain & Fever is an oral suspension formulation containing acetaminophen at a concentration of 160 mg per 5 mL. This product serves as a pain reliever and fever reducer, utilizing the same active ingredient as Infants' Tylenol®. The formulation is presented in a 2 fl oz (59 mL) bottle and is characterized by its blueberry flavor. Genexa® is distinguished by its commitment to clean medicine, containing 0% artificial additives and being free from common allergens, artificial preservatives, flavors, and dyes. This product is also available in a similar formulation under the name Genexa Kids' Pain & Fever.

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

Healthcare professionals should instruct caregivers to shake the product well before each use. Dosing should be determined primarily by the child's weight; however, if weight is not available, age may be used as a secondary guide.

To prepare the dose, caregivers should push air out of the syringe, insert the syringe tip into the bottle opening, and then flip the bottle upside down. The white part of the syringe should be pulled to the correct dose as indicated in the dosage chart below:

• For children weighing under 24 lbs. or under 2 years of age, caregivers should consult a doctor for the appropriate dose.

• For children weighing between 24-35 lbs. or aged 2-3 years, the recommended dose is 5 mL.

The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but caregivers must not exceed 5 doses within a 24-hour period.

It is essential to use only the enclosed syringe specifically designed for this product; no other dosing device should be utilized.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Additionally, this product must be kept out of reach of children to prevent accidental ingestion. Exceeding the recommended dosage is also contraindicated due to the risk of overdose.

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 cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a 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

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is taken concurrently with other medications containing acetaminophen. Additionally, there is a risk of 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 and seek immediate medical assistance.

Patients should be advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. These symptoms may indicate a more serious condition requiring prompt evaluation.

It is recommended that patients stop using the product and seek medical advice if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if redness or swelling is observed. These could be indicative of a serious underlying condition.

Before using this product, it is essential to consult a healthcare provider if the child has a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

In cases of overdose, immediate medical attention is crucial. Parents and caregivers should contact a Poison Control Center or seek medical help right away, 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to bleeding. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 24 lbs. and under 2 years of age should consult a doctor before use. For children weighing between 24-35 lbs. and aged 2-3 years, the recommended dose is 5 mL.

Healthcare professionals should advise caregivers to seek medical guidance if the child has liver disease or is taking the blood-thinning medication warfarin.

Dosing should ideally be based on the child's weight; however, age may be used as an alternative if weight is not available. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Geriatric Use

The prescribing information for Genexa Infants' Pain and Fever (acetaminophen suspension) does not provide specific guidance regarding the use of this medication in geriatric patients. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients.

Healthcare providers should exercise caution when considering the use of this medication in geriatric patients, given the absence of data on its safety and efficacy in this population. It is advisable to monitor elderly patients closely for any adverse effects or unusual responses to treatment, as they may have different pharmacokinetic and pharmacodynamic profiles compared to younger populations.

Pregnancy

There is no specific information available regarding the use of Genexa Infants' Pain and Fever (acetaminophen suspension) during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider before using this medication.

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 product 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. 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 evaluate 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 of an overdose may include supportive care and symptomatic treatment, tailored to the individual patient's needs. 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a doctor or pharmacist.

Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: pain worsens or persists for more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious condition that requires further evaluation.

It is important to emphasize that patients should not exceed the recommended dose of this medication, as doing so may lead to overdose. Additionally, healthcare providers should advise patients to consult a doctor before use if their child has liver disease. Furthermore, patients should be encouraged to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of this product.

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 Genexa Infants Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)