Infants Pain Fever

Description

Infants’ Pain & Fever is an oral suspension containing acetaminophen at a concentration of 160 mg per 5 mL. This formulation serves as a pain reliever and fever reducer specifically designed for infants aged 2 to 3 years. The product is free from alcohol, aspirin, ibuprofen, parabens, high fructose corn syrup, and dyes. It is presented in a grape flavor and is packaged in a 2 FL OZ (59 mL) bottle.

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 healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is essential to shake the product well before each use.

For administration, the following steps should be followed:

1. Preparation: Use only the enclosed syringe specifically designed for this product. Do not substitute with any other dosing device.

2. Syringe Filling:

   • Push the air out of the syringe before inserting the tip into the bottle opening.

   • 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.

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

3. Administration: Dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek.

The recommended dosing intervals are as follows:

• Administer the dose every 4 hours while symptoms persist.

• Do not exceed 5 doses in a 24-hour period.

Dosing should be determined according to the following chart:

• For children weighing under 24 lb or 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 5 mL.

It is crucial to replace the cap tightly after use to maintain child resistance. Healthcare professionals should ensure that caregivers are aware of the overdose warning and the importance of not exceeding the recommended dosage.

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.

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 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 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 with 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 contact a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, fever that worsens or 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 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 of these symptoms occur, patients should discontinue 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 are advised to consult a doctor promptly.

Patients should stop using the product 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 crucial 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 present.

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 doctor for dosing recommendations. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 5 mL. It is advised to use weight for dosing 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.

Healthcare professionals should be aware of several warnings associated with this product. There is a significant risk of severe liver damage if more than 5 doses are taken within 24 hours. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash; if any of these occur, use should be discontinued immediately, and medical assistance sought. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. Prior to use, it is important to ask a doctor if the child has liver disease or is taking the blood-thinning medication warfarin.

Storage conditions should be maintained at 20-25°C (68-77°F). It is essential to use only the enclosed syringe specifically designed for this product and to avoid using any other dosing device.

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 evaluate 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, 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 lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data 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 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 and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation is necessary to ensure the safe and effective use of the medication 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 intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention can significantly impact the outcome of an overdose situation. It is crucial to monitor the patient closely and provide supportive care as needed while awaiting further medical guidance.

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

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 immediately and seek medical assistance.

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. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to ensure that the printed neckband remains intact; the product must not be used if the neckband is broken or missing.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice 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.

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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