Infants Pain Fever

Description

Infants’ Pain & Fever Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever in children aged 2 to 3 years. Each 5 mL dose contains 160 mg of acetaminophen as the active ingredient. This product is alcohol-free, aspirin-free, ibuprofen-free, paraben-free, and does not contain high fructose corn syrup or dyes. It is presented in a cherry flavor and is packaged in a 2 FL OZ (59 mL) bottle. Administration is facilitated through the use of the enclosed syringe, with additional information available on the side panel.

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, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for pediatric use only and does not contain complete directions or warnings for adult administration. Healthcare professionals should ensure that the dosage does not exceed the recommended limits, as indicated in the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as a secondary reference.

To prepare the dose, healthcare professionals should follow these steps:

1. Push the air out of the syringe and insert the syringe tip into the bottle opening.

2. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

3. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

For dosing, refer to the following chart:

• For children weighing under 24 lb or under 2 years of age, the dose is to be determined by a doctor.

• For children weighing between 24-35 lb and aged 2-3 years, the dose is 5 mL.

It is essential to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized. After use, the cap should be replaced tightly to maintain child resistance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

• Exceeding the recommended dosage is contraindicated, as it poses a 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 has been associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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 for use in children. 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 signs or symptoms are apparent.

Patients should be advised to discontinue use and contact a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition.

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 dosage 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. Patients should be vigilant for signs of liver injury and consult a healthcare professional if there are concerns.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is crucial to discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a doctor promptly, as these symptoms may indicate a more serious condition.

It is advised that patients stop using the product and consult a healthcare provider if pain worsens or lasts longer than five days, if fever worsens or persists beyond three days, if new symptoms arise, or if there is any redness or swelling present, as these could be signs of a serious condition.

Furthermore, patients should seek medical advice before using this product if they have a history of liver disease. Caution is also recommended for those taking the blood-thinning medication warfarin, and they should consult a doctor or pharmacist prior to use.

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional for dosing recommendations. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 5 mL. Dosing should be based on weight when possible; otherwise, age may be used. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Caution is advised in pediatric patients with a history of allergic reactions to this product or any of its ingredients. Prior to use, consultation with a healthcare provider is recommended for children with liver disease or those taking the anticoagulant warfarin.

The product should be stored at a temperature of 20-25°C (68-77°F) and should only be administered using the enclosed syringe.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for inadequate information on safety and efficacy in this population. It is essential to monitor elderly patients closely for any adverse effects and to assess the appropriateness of the dosage based on individual health status and comorbidities.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 patients 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 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 medical 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 implemented 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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain 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.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor 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.

Patients must be cautioned against exceeding the recommended dosage, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, 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 a configuration that includes a specific syringe designed exclusively for its use. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the product is not utilized if the printed neckband is broken or missing, as this may indicate compromised safety or quality. Proper handling and adherence to these storage conditions are crucial for optimal performance.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin.

Patients should be instructed to 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, as these may indicate a serious condition.

Drug Information (PDF)

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

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