Temperal-Ito

Description

Temperal-ito is a pediatric formulation indicated for the management of fever in children. It is available in a 4 fluid ounce (floz) dosage form. The product is identified by the National Drug Code (NDC) 69729-006-04.

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

Healthcare professionals should instruct patients to shake the medication well before use. Dosing should be determined using the provided dosage chart, prioritizing weight for dosing; if weight is not available, age may be used as a secondary measure.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses administered within a 24-hour period. It is essential to utilize only the enclosed measuring syringe for accurate dosing.

The following dosage chart should be referenced for appropriate dosing:

• For patients weighing under 24 lbs or under 2 years of age, consultation with a doctor is advised.

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

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

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

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

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

Patients should not exceed 5 consecutive days of treatment unless directed by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited 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.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if more than 5 doses are administered within a 24-hour period, or if used concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to the recommended dosage guidelines to mitigate the risk of liver injury.

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 underlying condition that requires medical evaluation.

Prior to administration, it is essential to inquire about the child's medical history. Specifically, caregivers should be advised to consult a healthcare provider if the child has a history of liver disease. Additionally, if the child is currently taking warfarin or any other anticoagulant, it is crucial to seek guidance from a healthcare professional or pharmacist before use to prevent potential drug interactions.

Caregivers should be instructed to discontinue use and contact a healthcare provider if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts longer than 3 days. These signs may indicate a serious condition that necessitates further medical assessment.

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 be advised to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended.

In cases where patients experience a severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, they should seek medical attention promptly.

Patients with a history of liver disease should consult a doctor before using this product. Additionally, those taking the blood-thinning medication warfarin are advised to seek guidance from a healthcare professional prior to use.

While using this product, it is crucial not to exceed the recommended dosage. An overdose may lead to liver damage, and in such instances, immediate medical assistance or contact with a Poison Control Center is essential. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are initially apparent.

Patients should 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 more than 3 days, as these may indicate a serious condition.

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 toxicity. 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 Temperal-Ito (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lb should be advised to consult a doctor before use. For children aged 2 to 3 years weighing between 24-35 lb, the recommended dosage is 5 mL. For those aged 4 to 5 years weighing 36-47 lb, the dosage increases to 7.5 mL. Children aged 6 to 8 years weighing 48-59 lb should receive 10 mL, while those aged 9 to 10 years weighing 60-71 lb may be given 12.5 mL. Finally, children aged 11 years weighing 72-95 lb can take 15 mL.

Healthcare professionals should be aware of several warnings associated with use in pediatric patients. Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. 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, acetaminophen may cause severe skin reactions, including skin reddening, blistering, or rash; if any of these symptoms occur, use should be discontinued, and medical help sought immediately. It is also important to ask a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or a Poison Control Center contacted. Quick medical attention is critical for both children and adults, even if no signs or symptoms are present.

Dosing should not exceed the recommended amounts, with doses repeated every 4 hours as needed while symptoms persist. No more than 5 doses should be administered in a 24-hour period, and use should not extend beyond 5 days unless directed by a doctor.

Geriatric Use

Elderly patients should exercise caution when using this product, as it does not contain specific directions or complete warnings for adult use. It is advisable for geriatric patients to consult a healthcare provider prior to use, particularly if they have underlying health conditions such as liver disease.

Additionally, elderly patients who are concurrently taking anticoagulants, such as warfarin, should seek guidance from a doctor or pharmacist before using this product. Quick medical attention is essential for elderly patients, even in the absence of noticeable signs or symptoms, to ensure safety and appropriate management of any potential adverse effects.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no explicit statements concerning contraindications or risks to the fetus. Additionally, no dosage modifications for pregnant individuals are specified, and the insert does not include any special precautions regarding the use of this product in this population. Healthcare professionals should consider the lack of information when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

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

Taking more than the recommended dose of this 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 aware that the potential for liver damage necessitates a high index of suspicion in cases of suspected overdose. Monitoring and supportive care may be required, and specific management protocols should be followed based on the clinical presentation and the amount ingested.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blistering, 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 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 product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. They should be instructed 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, if a fever intensifies or lasts more than three days, patients should be advised to stop use and consult a doctor, as these may indicate a serious underlying condition.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and to be aware of the overdose warning associated with this product. It is also crucial to recommend that patients consult a doctor before use 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.

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. Proper storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients or caregivers to consult a doctor before use if the child has liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin. Patients should be instructed to discontinue use and consult a healthcare professional if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

Drug Information (PDF)

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

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