Temp X

Description

Temp X is a liquid formulation indicated for the management of fever in children. It is supplied in a 4 fluid ounce (floz) bottle. The product is identified by the National Drug Code (NDC) 69729-047-04.

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 sore throat, the common cold, influenza, headache, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients and should be administered with caution. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosage chart below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

Dosing should be repeated every 4 hours as needed while symptoms persist. Administration should not exceed 5 doses within a 24-hour period, and treatment should not continue for more than 5 days unless directed by a healthcare professional. The enclosed measuring syringe must be used for accurate dosing.

Dosage Chart:

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

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals are advised to always verify the appropriateness of the medication with a doctor before administration to infants or children.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or non-prescription. This is to prevent the risk of acetaminophen overdose, which can lead to severe liver damage.

Additionally, the product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients present in this formulation. Use in these cases may result in serious allergic reactions.

Warnings and Precautions

Severe liver damage may occur in children who take more than five doses of this product containing acetaminophen within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of liver damage increases if the child is concurrently using other medications that contain acetaminophen.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare providers should inquire about the child's medical history, particularly regarding liver disease, before recommending this product. Furthermore, it is advisable to consult a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

Parents and caregivers should monitor for any new symptoms that may arise during treatment. If new symptoms develop, or if there is noticeable redness or swelling, worsening pain lasting more than five days, or a fever that worsens or persists beyond three days, it is crucial to discontinue use and seek medical advice, as these may indicate a serious underlying condition.

Side Effects

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

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is advised to consult a healthcare professional before use if the patient has liver disease or is taking the blood-thinning medication warfarin.

In the event of an overdose, which may result from taking more than the recommended dose, liver damage can occur. Immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt attention is critical for both adults and children, even if no symptoms are initially apparent.

Patients should discontinue use and consult a doctor if new symptoms arise, if there is redness or swelling, if pain worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days. These symptoms may indicate a serious condition that requires medical evaluation.

Furthermore, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to seek medical advice promptly.

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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

Packaging & NDC

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

Pediatric Use

Severe liver damage may occur in pediatric patients if more than 5 doses are administered within a 24-hour period, which is the maximum daily amount. This medication should not be used in children who are allergic to acetaminophen or any of the inactive ingredients present in the formulation. Prior to administration, it is advisable to consult a healthcare professional if the child has liver disease or is concurrently taking the anticoagulant warfarin.

Dosing should be determined using the provided weight-based chart, with weight being the preferred method; if weight is not available, age may be used. Doses can be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician. The following dosing guidelines apply:

• For children under 24 lbs (under 2 years): Consult a doctor.

• For children 24-35 lbs (2-3 years): 5 mL.

• For children 36-47 lbs (4-5 years): 7.5 mL.

• For children 48-59 lbs (6-8 years): 10 mL.

• For children 60-71 lbs (9-10 years): 12.5 mL.

• For children 72-95 lbs (11 years): 15 mL.

It is essential to use the enclosed measuring syringe for accurate dosing and to always check with a healthcare provider before administering this medication to an infant or child.

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

Pregnant patients may use this product as there are no specific warnings or precautions regarding its use during pregnancy mentioned in the provided text. The insert does not indicate whether the product is contraindicated in pregnancy or if there are any risks to the fetus associated with its use during this period. Additionally, no dosage modifications or special precautions for pregnant individuals are provided. Healthcare professionals should consider the absence of data when counseling women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data 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 exercise caution when using this product, as it contains acetaminophen. Severe liver damage may occur if the maximum daily amount of 5 doses is exceeded within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen.

It is recommended that a healthcare professional be consulted prior to use in patients with liver disease to assess the appropriateness of treatment and to determine any necessary dosage adjustments or monitoring requirements.

Overdosage

Taking more than the recommended dose of the medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be vigilant in monitoring for potential symptoms of overdose, which may not always be immediately apparent. The importance of rapid response cannot be overstated, as early treatment can significantly mitigate the risk of severe 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this medication if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the product. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, patients should be advised to stop use and consult a doctor if a fever worsens or lasts more than three days, as these may indicate a serious underlying condition.

It is also essential for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15° to 30°C (59° to 86°F). Care must be taken to protect the product from freezing, as well as from light exposure to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period and should not continue treatment for more than 5 days unless directed by a healthcare professional.

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

Drug Information (PDF)

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

View product document (PDF)