Infants Pain and Fever

Description

Acetaminophen is provided in a suspension liquid form, delivering 160 mg of acetaminophen per 5 mL. This formulation is alcohol-free, aspirin-free, and ibuprofen-free, ensuring it is suitable for a wide range of patients. The product does not contain high fructose corn syrup and is dye-free, making it appropriate for those with sensitivities to artificial colors. It features a grape flavor for palatability. The product is packaged in a 2 FL OZ (59 mL) container and is intended for use with the enclosed syringe for accurate dosing.

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 directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose can be determined using the provided dosing chart, which recommends using the child's weight for dosing whenever possible; otherwise, age may be used as a guide.

To prepare the dose, the following steps should be followed:

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

2. Invert the bottle 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 remains at the correct dose.

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 should not exceed 5 doses within a 24-hour period.

The dosing chart is as follows:

• 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 or aged 2-3 years, the recommended dose is 5 mL.

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

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, 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.

This product is contraindicated in patients with a known history of allergic reactions to this product or any of its components.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to serious health risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is 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, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists for more than three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent. Prompt intervention is essential to mitigate potential health risks.

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. Patients should be monitored for signs of liver injury, particularly in those with pre-existing liver disease.

Additionally, there is an allergy alert indicating that acetaminophen may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Participants should also be aware of the sore throat warning. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Furthermore, it is recommended to seek medical advice before use if the child has liver disease or is concurrently taking the blood-thinning medication warfarin.

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

Pediatric Use

Pediatric patients under 2 years of age should not be given this product without consulting a doctor. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24-35 pounds. It is crucial to adhere strictly to the dosing instructions and not exceed the recommended dose, as indicated in the overdose warning.

Only the enclosed syringe designed for this product should be used for dosing; other devices are not appropriate. Prior to administration, healthcare professionals should be consulted if the child has liver disease or is taking the anticoagulant warfarin.

This product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

If a child has a history of allergic reactions to this product or any of its components, it should not be used. Parents or caregivers should discontinue use and consult a doctor if the child's 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, as these may indicate a serious condition.

This product is not intended for adult use, and complete warnings for such use are not provided.

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 considering this product for geriatric patients, as the absence of comprehensive information may impact safety and efficacy. It is essential to monitor these patients closely and consider alternative therapies that provide clearer dosing and safety profiles.

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

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 due to the potential risk to the infant.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

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 and ongoing monitoring may be necessary 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 essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals are advised to remain vigilant and act swiftly, as timely medical attention can significantly influence the outcome of an overdose situation. It is crucial to monitor the patient closely for any emerging symptoms, even if they initially appear asymptomatic.

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 elucidate these aspects of nonclinical toxicology.

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 about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

It is essential to instruct patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, they should be advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage, in line with the overdose warning. Furthermore, it is advisable for patients to seek medical advice before use if their child has liver disease. Lastly, patients should be encouraged to consult a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, 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 taking the blood-thinning medication 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, as these may indicate a serious condition.

Drug Information (PDF)

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

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