Pediacare Infants Fever Reducer Cherry

Description

NEW PediaCare® Infants Fever Reducer Pain Reliever is formulated specifically for infants. It is presented in a liquid dosage form, with a volume of 1 fluid ounce (30 mL). The product features a cherry flavor, enhancing palatability for pediatric use.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should adhere to the following guidelines for the administration of this product. Prior to use, the product must be shaken well to ensure proper mixing. It is essential to utilize only the enclosed dosing device for accurate measurement. The dosing should be filled to the indicated dose level.

For administration, dispense the liquid slowly into the child’s mouth, directing it towards the inner cheek to facilitate swallowing. Dosing may be repeated every 4 hours as needed; however, it is critical not to exceed 5 doses within a 24-hour period. Continuous use should not exceed 5 days unless directed by a physician.

Dosing should be determined using the chart provided below. When possible, weight should be used for dosing; if weight is not available, age may be used as a guide.

Dosage Chart:

• For children weighing under 24 lb and under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing between 24-35 lb and aged 2-3 years, the recommended dose is 1.6 mL (administered as two 0.8 mL doses).

After use, ensure the dropper is used to securely close the bottle, maintaining child resistance. It is imperative to follow these instructions closely to avoid overdose and ensure safe administration.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other product containing acetaminophen, whether prescription or non-prescription, 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.

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

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 concurrently use other medications containing acetaminophen. Healthcare professionals should advise parents and caregivers to monitor the total intake of acetaminophen from all sources to prevent potential toxicity.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Healthcare providers should inquire about the child’s medical history, particularly regarding liver disease, before recommending this product. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as interactions may occur.

Parents and caregivers should be instructed to discontinue use and seek medical advice if the child experiences worsening pain lasting more than 5 days, fever that worsens or persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious condition that necessitates further investigation and intervention.

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 five doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients are advised to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other products containing acetaminophen, whether prescription or non-prescription. Patients should seek medical advice if they are uncertain whether a drug contains acetaminophen. Additionally, the product is contraindicated in patients with known allergies to acetaminophen or any of the inactive ingredients.

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

While using this product, it is crucial not to exceed the recommended dose. Patients should discontinue use and consult a doctor if pain worsens or lasts more than five days, if fever worsens or lasts more than three days, if new symptoms occur, or if redness or swelling is present, as these may indicate a serious condition.

In the event of an overdose, which may result in liver damage, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is essential, even if no signs or symptoms are immediately apparent.

Drug Interactions

Co-administration of this product with any other formulation containing acetaminophen, whether prescription or non-prescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the child is concurrently taking warfarin, a blood-thinning medication. This is essential to ensure appropriate monitoring and to mitigate the risk of potential interactions that could affect coagulation parameters.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not receive more than the directed dose, and an enclosed dosing device must be used to ensure accurate measurement. The liquid should be dispensed slowly into the child’s mouth towards the inner cheek. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period. Treatment should not continue for more than 5 days unless directed by a healthcare professional.

For dosing, it is recommended to use weight for accuracy; if weight is not available, age may be used. The following dosing guidelines apply:

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

• For patients weighing between 24 to 35 pounds and aged 2 to 3 years, the recommended dose is 1.6 mL (administered as two 0.8 mL doses).

Healthcare professionals should ensure that these guidelines are followed to promote safety and efficacy in pediatric use.

Geriatric Use

There is no specific information regarding the use of PediaCare Infants Fever Reducer Cherry (acetaminophen liquid) in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients.

Given the absence of data, it is advisable to monitor geriatric patients closely for any potential adverse effects or changes in response to treatment. Additionally, healthcare providers may need to consider individual patient factors, such as comorbidities and concurrent medications, when determining the appropriateness of this medication for elderly patients.

Due to the lack of established guidelines for geriatric use, dose adjustments may be necessary based on clinical judgment and patient-specific considerations.

Pregnancy

There are no specific statements regarding the use of PediaCare Infants Fever Reducer Cherry (acetaminophen liquid) during pregnancy. Available data do not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. However, healthcare professionals should consider the overall clinical context and the potential risks versus benefits when recommending this medication to women of childbearing potential. As with any medication, it is advisable to consult relevant clinical guidelines and consider individual patient circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 tests may be warranted to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of symptoms may not be immediately apparent, making it essential to act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, it is imperative to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Even in the absence of noticeable signs or symptoms, prompt medical evaluation is necessary to mitigate potential complications associated with overdose. Early intervention can be critical in preventing serious health consequences.

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

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. It is crucial to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. 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 the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is important to emphasize that patients must not exceed the recommended dosage while using this product, and they should be made aware of the overdose warning associated with it. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a configuration that includes an enclosed dosing device. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) to ensure its efficacy and safety. Prior to use, the product must be shaken well to ensure proper mixing of its components.

For dispensing, it is crucial to utilize only the enclosed dosing device. After each use, the dropper should be securely closed to maintain child resistance and prevent any accidental exposure.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and that the medication is not used for more than 5 consecutive days unless directed by a healthcare professional. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)