Dr Kids

Description

Dr Kids Pain and Fever contains acetaminophen as its active ingredient. Acetaminophen is a widely used analgesic and antipyretic agent. The formulation is designed for pediatric use, providing effective relief from pain and fever in children. The product is available in a liquid dosage form, ensuring ease of administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore throat and headache, as well as for the reduction of fever.

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

Dosage and Administration

Healthcare professionals should adhere to the following dosage and administration guidelines.

For patients under 2 years of age, it is imperative to consult a doctor prior to administration. For children aged 2 to under 6 years, the recommended dose is 1 vial (5 mL). For those aged 6 to 11 years, the recommended dose is 2 vials (10 mL).

Dosing may be repeated every 4 hours as needed while symptoms persist, with a maximum of five doses within a 24-hour period. It is essential to follow the “Easy to Use” instructions provided on the pouch to ensure proper administration.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is to prevent the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if more than 5 doses are taken within a 24-hour period. This dosage represents the maximum daily amount for acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to prevent potential hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin redness, blisters, or rash. It is essential for healthcare providers to inform patients and caregivers of this risk and to monitor for any signs of allergic reactions.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. This recommendation is crucial to rule out any serious underlying conditions.

Before administering this product, healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease. Additionally, caution is advised for patients who are concurrently taking the anticoagulant warfarin; consultation with a doctor or pharmacist is recommended prior to use.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that lasts more than 3 days, presence of redness or swelling, or the emergence of any new symptoms. These signs may indicate a need for further evaluation and intervention.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is critical, even if no signs or symptoms are initially apparent, to mitigate potential adverse effects.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of acetaminophen are taken within a 24-hour period, which is the maximum daily amount for this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin redness, blisters, or rash.

In clinical practice, it is advised that patients consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, patients should discontinue use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear.

Patients with a history of liver disease should consult a doctor before using this product. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin seek advice from a doctor or pharmacist prior to use.

In the event of an accidental overdose, it is critical to obtain 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 initially evident.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the child is concurrently taking warfarin, a blood-thinning agent. This is important to ensure appropriate monitoring and to mitigate the risk of potential interactions that could affect coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Dr Kids (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to under 6 years, the recommended dose is 1 vial (5 mL), while those aged 6 to 11 years may receive 2 vials (10 mL). Dosing may be repeated every 4 hours as needed, not exceeding five doses in a 24-hour period unless directed by a physician.

Caution is advised regarding liver health; severe liver damage may occur if more than 5 doses are taken within 24 hours, which is the maximum daily limit for this product. Parents and caregivers should consult a doctor before use if the child has liver disease. Additionally, it is important to seek advice from a doctor or pharmacist if the child is concurrently taking the blood-thinning medication warfarin.

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

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with acetaminophen use during pregnancy. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential 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 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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of acetaminophen, which is 5 doses in 24 hours, is exceeded. Therefore, dosage adjustments may be necessary for patients with compromised liver function to avoid the risk of hepatotoxicity.

Before administering this product, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in individuals with hepatic impairment. Regular assessment of liver function may be warranted to monitor for any potential adverse effects associated with acetaminophen use in this population.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may require specific interventions based on the substance involved and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any potential complications that arise from the overdose.

It is essential to maintain a high index of suspicion for overdose in patients presenting with unexplained symptoms, as early recognition and treatment can significantly improve outcomes.

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 severe skin reactions associated with acetaminophen. Reported symptoms include skin redness, blisters, and rash. These events have been documented through voluntary reports and surveillance programs.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an accidental overdose. It is important to emphasize that prompt medical attention is critical, even if no signs or symptoms are initially observed.

Patients must be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in any other medication, patients should be encouraged to consult with a healthcare provider or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: if pain worsens or persists for more than 5 days; if fever worsens or lasts more than 3 days; if redness or swelling is observed; or if any new symptoms develop.

It is essential to advise patients to consult a healthcare provider before using this medication if their child has liver disease. Additionally, patients should be encouraged to speak with a healthcare provider or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in pouches and vials, with specific attention to the integrity of the packaging. It is essential to store the product at a temperature range of 68-77°F (20-25°C) to maintain its efficacy. Healthcare professionals should ensure that the pouches or vials are not punctured, torn, or open prior to use, as compromised packaging may affect the product's safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)