Foster and Thrive Pain Reliever

Description

Foster & Thrive™ is a pediatric formulation designed for children aged 3 to 6 years. Each suppository contains 120 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is available in a dosage form of rectal suppositories, with a total of 12 units per package. This formulation is comparable to FeverAll®.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches, pains, and headaches.

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

Dosage and Administration

This product is not indicated for use in adults. For pediatric patients under 3 years of age, the product should not be used unless directed by a physician.

For children aged 3 to 6 years, the recommended dosage is 1 suppository administered every 4 to 6 hours, with a maximum of 5 doses within a 24-hour period.

Prior to administration, the wrapper should be removed. The suppository should be carefully inserted well up into the rectum to ensure proper delivery of the medication. It is imperative to adhere strictly to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen may also trigger severe skin reactions, which can 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.

Healthcare providers should inquire about the child's medical history prior to recommending this product, particularly if the child has a history of liver disease or is currently taking the anticoagulant warfarin. These conditions may necessitate additional monitoring or alternative treatment options.

In cases of accidental ingestion or suspected 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.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: fever lasting more than three days (72 hours) or recurring, pain persisting beyond five days or worsening, the emergence of new symptoms, or the presence of redness or swelling in the affected area. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the medication are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases when the medication is used concurrently with other drugs containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms 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.

Patients with a known allergy to acetaminophen should not use this medication. Furthermore, it should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

Before using this medication, it is recommended that patients consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin.

Patients should discontinue use and seek medical advice if fever persists for more than 3 days (72 hours) or recurs, if pain lasts more than 5 days or worsens, if new symptoms arise, or if redness or swelling is observed in the painful area, as these may indicate a serious condition.

Drug Interactions

The concomitant use of warfarin, an anticoagulant, with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. This combination may increase the risk of bleeding due to the potential for acetaminophen to affect warfarin metabolism and its anticoagulant effect.

No specific laboratory test interactions have been identified in the provided data. Therefore, routine monitoring of coagulation parameters is recommended when warfarin is used, particularly when initiating or discontinuing any medications that may interact.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a healthcare professional. For children aged 3 to 6 years, the recommended dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period.

It is important to note that exceeding 5 doses in 24 hours may lead to severe liver damage. Parents and caregivers should be vigilant for potential severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, use should be discontinued immediately, and medical assistance should be sought.

This medication must be kept out of reach of children. In the event of accidental ingestion or overdose, immediate medical help should be obtained, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt attention is crucial.

Before administering this medication, it is advisable to consult a healthcare provider if the child has liver disease or is taking the anticoagulant warfarin. Additionally, caregivers should discontinue use and seek medical advice if a child's fever persists for more than 3 days (72 hours), pain lasts longer than 5 days or worsens, new symptoms develop, or if there is redness or swelling in the affected area.

Geriatric Use

Elderly patients may not have specific directions or warnings for adult use associated with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique pharmacokinetic and pharmacodynamic changes that occur with aging, which may affect the safety and efficacy of the treatment.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to assess the need for dosage adjustments based on individual patient characteristics and clinical response. Given the absence of specific guidance for this population, careful clinical judgment is paramount in managing therapy for geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and its use is not recommended unless directed by a physician. Additionally, there are no specific risk categories provided; therefore, caution is advised when considering this medication for women of childbearing potential. It is essential to 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 of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, or concomitant use with other medications containing acetaminophen, may significantly increase the risk of liver injury.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in patients with compromised liver function. Regular assessment of liver function may be warranted in these patients to mitigate potential risks associated with acetaminophen use.

Overdosage

In the event of an overdose, immediate medical assistance is essential. Healthcare professionals are advised to instruct patients or caregivers 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.

It is important to note that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Vigilance in monitoring for potential symptoms is necessary, as the absence of immediate effects does not preclude the possibility of serious complications.

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 these contexts.

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 if the medication is swallowed or in the event of an overdose. It is crucial to emphasize that prompt medical attention is essential in cases of overdose, particularly for adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use the medication if they have a known allergy to acetaminophen. Additionally, they should be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of another medication, they should be encouraged to consult with a doctor or pharmacist.

Patients should be instructed to discontinue use and consult a doctor if a fever persists for more than 3 days (72 hours) or if it recurs. Similarly, they should stop using the medication and seek medical advice if pain lasts longer than 5 days or worsens. It is also important to advise patients to stop use and contact a healthcare professional if new symptoms arise or if there is any redness or swelling in the area of pain, as these may indicate a serious condition.

For pediatric patients, healthcare providers should recommend consulting a doctor before use if the child has liver disease or is taking the anticoagulant medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident configuration, with each suppository individually wrapped. It is essential to inspect the packaging prior to use; do not utilize any suppository if the printed wrapper is opened or damaged.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F) or in a cool place to ensure its integrity and effectiveness.

Additional Clinical Information

The route of administration for the medication is rectal, with a recommended dosage of one suppository every 4 to 6 hours, not exceeding five doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children. In the event of accidental ingestion or overdose, immediate medical assistance should be sought, and patients are encouraged to contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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