Childrens Acetaminophen Oral Suspension

Description

Genexa® is a clean medicine formulation containing Acetaminophen at a concentration of 160 mg per 5 mL, presented as an oral suspension. This product serves as a pain reliever and fever reducer, comparable to the active ingredient found in Children's Tylenol® Oral Suspension Grape. The formulation is free from high fructose corn syrup, FD&C blue no. 1, D&C red no. 33, and other specified additives. It features an organic blueberry flavor and is free from ibuprofen and aspirin. Each package contains 4 fl oz (118 mL) of the suspension, accompanied by a dosing cup for accurate measurement.

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 patients to shake the medication well before use. For accurate dosing, it is essential to utilize the measuring cup provided with the medication; other dosing devices should not be used.

Dosing should be determined primarily by the patient's weight; however, age may be used as an alternative if weight is not available. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations based on weight and age:

• For patients weighing under 24 lbs. or under 2 years of age, it is advised to consult a physician for appropriate dosing.

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

• For patients weighing between 36-47 lbs. or aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing between 48-59 lbs. or aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing between 60-71 lbs. or aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing between 72-95 lbs. or aged 11 years, the recommended dose is 15 mL.

It is crucial to adhere to these guidelines to ensure safe and effective administration of the medication.

Contraindications

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

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 five doses should be administered within a 24-hour period. Additionally, caution is warranted when this 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. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

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

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, prior to recommending this product. Furthermore, it is advisable to consult with a doctor or pharmacist if the patient is concurrently taking warfarin or any other anticoagulant medication.

In the event of an overdose, immediate medical attention is critical. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These signs 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 is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen.

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

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

Patients are instructed to stop use and consult a healthcare professional 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. These symptoms may indicate a serious condition.

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, as prompt medical attention is essential even if no signs or symptoms are initially 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. 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 Childrens Acetaminophen Oral Suspension (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 used; other dosing devices are not recommended. 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; if not, age may be utilized. The following dosing guidelines apply:

• 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), 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.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any potential implications with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the absence of data when advising lactating mothers about the use of this medication. Further clinical judgment may be necessary based on individual circumstances.

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 to determine the appropriateness of treatment and any necessary dosage adjustments. Monitoring of liver function may be required 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 presentation of symptoms may vary, and vigilance is necessary to ensure patient safety. The management of an overdose may involve supportive care and symptomatic treatment, tailored to the specific circumstances of the patient.

It is essential to monitor the patient closely and provide appropriate interventions as needed, based on clinical judgment and established protocols.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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 that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist for clarification.

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.

Additionally, it is important to advise patients to consult a doctor before using this medication if their child has liver disease. Patients should also be reminded to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin, as interactions may occur.

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

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is concurrently taking the anticoagulant warfarin. Patients should discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

This file contains official product information for Childrens Acetaminophen Oral Suspension, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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