Foster and Thrive Infants Pain and Fever

Description

Acetaminophen is provided in an oral suspension formulation, delivering 160 mg of acetaminophen per 5 mL. This product is designed for pediatric use, specifically for children aged 2 to 3 years. The suspension is free from aspirin, ibuprofen, parabens, alcohol, dyes, and gluten, making it suitable for sensitive populations. It is flavored with grape to enhance palatability. The total volume of the product is 2 fluid ounces (60 mL).

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, 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.

For administration, the enclosed syringe specifically designed for this product must be utilized. Other dosing devices are not recommended. To prepare the dose, the healthcare professional should follow these steps:

1. Push air out of the syringe.

2. Insert the syringe tip into the bottle opening.

3. 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.

4. 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. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period.

For specific dosing based on weight and age:

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

• For children weighing between 24 to 35 pounds and aged 2 to 3 years, the recommended dose is 5 mL.

It is imperative to replace the cap tightly after use to maintain child resistance. Additionally, healthcare professionals should advise caregivers not to exceed the recommended dosage and to be aware of the overdose warning associated with this product.

Contraindications

Use of this product is contraindicated in the following situations:

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

• This product should not be used in patients who have 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 with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or administering this product alongside other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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 two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should advise caregivers to consult a physician prior to use if the child has a history of liver disease. Additionally, it is prudent to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. 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.

Caregivers should be advised to discontinue use and contact a healthcare provider if the child experiences worsening pain that lasts more than five days, a fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, or who take this product in conjunction with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients with a known allergy to acetaminophen or any of its ingredients should also refrain from using this product.

Before using this product, patients with liver disease should seek medical advice. Additionally, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a healthcare provider if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are present, as prompt intervention is critical.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive Infants Pain and 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. Dosing should be based on weight whenever possible; otherwise, age may be used as a guide. It is crucial not to exceed the maximum daily limit of 5 doses within a 24-hour period, with doses to be repeated every 4 hours as needed.

Severe liver damage may occur if more than the recommended doses are administered, particularly in children with liver disease. Parents and caregivers should be aware that this product contains acetaminophen, which can lead to severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Consultation with a healthcare professional is advised if the child is taking warfarin or has any liver conditions.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

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 prescribing information does not provide specific data regarding the use of this product during pregnancy. As such, there are no stated safety concerns, dosage modifications, or special precautions associated with its use in pregnant patients. Healthcare professionals should consider the lack of information when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of acetaminophen on nursing infants are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on the severity of renal impairment.

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 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 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.

Providers should also instruct patients not to exceed the recommended dose, highlighting the importance of adhering to dosing guidelines to prevent potential overdose.

Additionally, healthcare providers should encourage patients to consult with a doctor before using the medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, it is important for healthcare providers to remind patients to speak with a doctor or pharmacist before administering the medication if their child is currently taking the blood-thinning medication warfarin. This discussion is vital to avoid any potential interactions that could compromise the child's health.

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 exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial even if no symptoms are apparent. It is advisable to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients should discontinue use and consult a healthcare professional if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if new symptoms or signs of redness or swelling occur, as these may indicate a serious condition.

Drug Information (PDF)

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

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