Drkids Childrens Pain and Fever

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for use in children, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age. It is crucial to adhere to the recommended dosing guidelines and not exceed the maximum dosage to avoid the risk of overdose.

For children weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for appropriate dosing. For children weighing between 24-35 lbs (ages 2-3), the recommended dose is 2 pieces. For those weighing 36-47 lbs (ages 4-5), the dose increases to 3 pieces. Children weighing 48-59 lbs (ages 6-8) should receive 4 pieces, while those weighing 60-71 lbs (ages 9-10) should be given 5 pieces. For children weighing 72-95 lbs (age 11), the recommended dose is 6 pieces.

Doses may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to administer more than 5 doses within a 24-hour period.

Healthcare professionals should instruct caregivers to ensure that children chew each piece thoroughly before swallowing to mitigate the risk of choking.

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 known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

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 5 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 be vigilant regarding the potential for severe sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be observed, particularly in patients with pre-existing conditions. It is advisable to consult a physician before administering this product to children with liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In cases of suspected overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent, as rapid intervention is essential for both adults and children.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child experiences worsening pain lasting more than 5 days, fever persisting beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of 5 doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate cessation of use and prompt medical attention are warranted.

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 without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this formulation should refrain from use.

Before administering this product, it is advisable for patients to consult a healthcare provider if there is a history of liver disease or if the patient is taking the anticoagulant warfarin.

During the use of this product, patients must adhere to the recommended dosage to avoid overdose. If pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, patients should discontinue use and seek medical advice. The emergence of new symptoms or the presence of redness or swelling may indicate a serious condition, necessitating immediate medical consultation.

In cases of overdose, it is critical to seek medical assistance or contact a Poison Control Center immediately, as timely intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 hepatotoxicity. 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 Drkids Childrens Pain and Fever (acetaminophen 80mg/piece). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a doctor. For children aged 2 to 3 years, the recommended dosage is 2 pieces; for those aged 4 to 5 years, 3 pieces; for children aged 6 to 8 years, 4 pieces; for 9 to 10 years, 5 pieces; and for 11 years, 6 pieces.

Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be stopped immediately, and medical help should be sought.

Parents and caregivers should be aware that if a child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

This product should not be used in children who are allergic to acetaminophen or any of the inactive ingredients. Prior to use, consultation with a doctor is advised if the child has liver disease or is taking the blood-thinning medication warfarin.

If pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, or if new symptoms occur, or if redness or swelling is present, use should be discontinued and a doctor should be consulted.

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 this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients and consider alternative therapies where appropriate.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of 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, 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 advisable to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to mitigate potential adverse effects related to compromised liver function.

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 for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based 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’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential 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 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 obtain prompt medical attention for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to refrain from using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Patients should be counseled to discontinue use and consult a doctor if pain worsens or persists for more than five days. Similarly, they should stop use and seek medical advice if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage, as indicated in the overdose warning. Additionally, healthcare providers should advise patients to consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a Child Resistant Container. It is essential to ensure that the printed seal under the cap is intact; do not use the product if the seal is broken or missing.

For optimal storage, the product should be kept in a cool, dry place, maintaining a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are crucial to preserve the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)