Childrens Nortemp

Description

SPL code 34089-3 corresponds to the product labeled as Children's Nortemp. This formulation is specifically designed for pediatric use, providing a targeted therapeutic option for managing fever and discomfort in children. The product's composition and dosage form are tailored to meet the needs of its intended demographic, ensuring both efficacy and safety.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It is also indicated for the temporary relief of minor aches and pains associated with conditions such as cold, flu, sore throat, headache, and toothache.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to ensure the product is shaken well before administration.

For patients under 2 years of age (weighing less than 24 lb), it is recommended to consult a physician for appropriate dosing.

For children aged 2 to 3 years (weighing between 24 and 35 lb), the recommended dosage is 1 teaspoon. For those aged 4 to 5 years (weighing between 36 and 47 lb), the dosage increases to 1 1/2 teaspoons.

Children aged 6 to 8 years (weighing between 48 and 59 lb) should receive 2 teaspoons, while those aged 9 to 10 years (weighing between 60 and 71 lb) should be administered 2 1/2 teaspoons.

For children aged 11 years (weighing between 72 and 95 lb), the recommended dosage is 3 teaspoons.

All dosages may be repeated every 4 hours, with a maximum of 5 doses administered in a 24-hour period.

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 due to the potential risk of acetaminophen overdose, which can lead to severe 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 in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should advise caregivers to strictly adhere to dosing guidelines and to avoid combining this product with any other acetaminophen-containing medications, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended.

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. These symptoms may indicate a more serious condition that requires medical evaluation.

Healthcare providers should inquire about the child’s medical history, particularly regarding liver disease, before recommending this product. Additionally, caution is advised when this product is used in conjunction with the anticoagulant warfarin; consultation with a doctor or pharmacist is essential in such cases.

If new symptoms arise, or if there is any redness or swelling, or if pain worsens or persists beyond 5 days, or if fever intensifies or lasts longer than 3 days, caregivers should be instructed to discontinue use and seek medical advice. These signs may suggest a serious underlying condition that necessitates further investigation.

It is crucial to keep this product out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay. Prompt medical attention is vital, even if no signs or symptoms are initially apparent.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product concurrently with other medications containing acetaminophen. It is crucial for patients to consult a healthcare professional if they have a history of liver disease prior to use.

In addition, patients should seek medical advice if they experience a severe sore throat that persists for more than two days, especially if accompanied by fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious condition requiring prompt evaluation.

Patients are advised to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days. These signs may suggest a more serious underlying issue.

Furthermore, caution is advised for patients taking the blood-thinning medication warfarin; consultation with a healthcare provider or pharmacist is recommended before using this product.

In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential, even if no symptoms are immediately apparent. Prompt medical attention is critical in such cases.

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 essential 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 Childrens Nortemp (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 3 years (24 - 35 lb), the recommended dosage is 1 teaspoon. For those aged 4 to 5 years (36 - 47 lb), the dosage increases to 1 1/2 teaspoons. Children aged 6 to 8 years (48 - 59 lb) may take 2 teaspoons, while those aged 9 to 10 years (60 - 71 lb) can take 2 1/2 teaspoons. For children aged 11 years (72 - 95 lb), the dosage is 3 teaspoons. All dosages may be repeated every 4 hours, not exceeding 5 doses in a 24-hour period.

Healthcare professionals should be aware of specific warnings associated with use in pediatric patients. Severe liver damage may occur if a child takes more than 5 doses in 24 hours or if used concurrently with other medications containing acetaminophen. 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. Additionally, it is advised to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Parents or caregivers should be instructed to stop use and consult a doctor if new symptoms occur, if redness or swelling is present, if pain worsens or lasts longer than 5 days, or if fever worsens or lasts longer than 3 days, as these may indicate a serious condition.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Children's Nortemp (acetaminophen solution) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that women of childbearing potential discuss the use of this medication with their healthcare provider to weigh 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 on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information 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. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early intervention can significantly impact patient outcomes in cases of overdosage.

It is recommended that healthcare providers remain vigilant and prepared to manage potential complications that may arise from an overdose. Continuous monitoring and supportive care may be necessary, depending on the severity of the situation and the specific substance involved.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an accidental overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical even if no signs or symptoms are present.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 5 days, or if fever intensifies or lasts for more than 3 days, as these may indicate a serious condition.

Additionally, patients should be advised to consult a doctor before using this medication if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tight container and should be stored at a temperature range of 20°-25°C (68°-77°F). It is essential to maintain these conditions to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with dosages that may be repeated every 4 hours, not exceeding 5 times daily. Clinicians should advise patients to keep the medication out of reach of children. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential even if no signs or symptoms are apparent.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)