Childrens Tukol Acetaminophen Fever Reducer Pain Reducer

Description

Children's Tukol® is an acetaminophen-based oral suspension formulated as a pain reliever and fever reducer. It is indicated for use in children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen. The product is presented in a 4 FL OZ (118 mL) bottle and features a cherry flavor. It is essential to note that the product should not be used if the printed neckband is broken or missing. This formulation is distributed by Genomma Lab USA Inc., located in Houston, TX 77027.

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

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

Dosage and Administration

The product is intended for use in pediatric patients, and healthcare professionals should note that it is not labeled with directions or complete warnings for adult use. Prior to administration, the product must be shaken well.

Dosing should be determined using the chart provided below, with preference given to weight for dosing; if weight is not available, age may be used as a secondary measure. Doses may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a physician.

Dosing Chart:

• For patients weighing under 24 lb or under 2 years of age: Consult a doctor.

• For patients weighing 24 - 35 lb or aged 2 - 3 years: Administer 5 mL (1 teaspoonful).

• For patients weighing 36 - 47 lb or aged 4 - 5 years: Administer 7.5 mL (1 1/2 teaspoonfuls).

• For patients weighing 48 - 59 lb or aged 6 - 8 years: Administer 10 mL (2 teaspoonfuls).

• For patients weighing 60 - 71 lb or aged 9 - 10 years: Administer 12.5 mL (2 1/2 teaspoonfuls).

• For patients weighing 72 - 95 lb or aged 11 years: Administer 15 mL (3 teaspoonfuls).

It is essential to use only the enclosed dosing cup specifically designed for this product to ensure accurate dosing.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, patients must not exceed the recommended dosage, as this may lead to overdose and associated risks.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five 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 is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended to rule out serious underlying conditions.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate the presence of a serious medical condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay, as rapid medical attention is essential even if no signs or symptoms are immediately apparent.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Before using this product, patients with liver disease should seek medical advice. Additionally, it is recommended that patients taking the blood-thinning medication warfarin consult a doctor or pharmacist prior to use.

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. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. 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 Childrens Tukol Acetaminophen Fever Reducer Pain Reducer (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 to 11 years, the recommended dosing is as follows:

• 2 - 3 years (24 - 35 lbs): 5 mL (1 tsp)

• 4 - 5 years (36 - 47 lbs): 7.5 mL (1 1/2 tsp)

• 6 - 8 years (48 - 59 lbs): 10 mL (2 tsp)

• 9 - 10 years (60 - 71 lbs): 12.5 mL (2 1/2 tsp)

• 11 years (72 - 95 lbs): 15 mL (3 tsp)

The maximum dosage should not exceed 5 doses in a 24-hour period, and the duration of use should not exceed 5 days unless directed by a doctor.

Caution is advised due to the risk of severe liver damage if the child takes more than 5 doses in 24 hours or if used concurrently with other medications containing acetaminophen. Consultation with a doctor is recommended if the child has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms develop, or if there is any redness or swelling.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Tukol Acetaminophen Fever Reducer Pain Reducer, as the drug insert does not provide any recommendations or considerations for this population. There are no stated age cutoffs, dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, given the absence of targeted data. It is advisable to monitor these patients closely for any potential adverse effects or complications that may arise from the use of this product.

Pregnancy

Safety during pregnancy has not been established for this product. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. While potential risks to the fetus are not clearly defined, caution is advised. There are no specific dosage modifications for pregnant individuals. It is recommended that women of childbearing potential discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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 of these patients.

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 recommended dosing guidelines, as exceeding 5 doses in a 24-hour period may lead to significant hepatic injury.

Due to the potential for compromised liver function to affect the metabolism of acetaminophen, patients with hepatic impairment should be advised against using this product in conjunction with other medications containing acetaminophen. Careful consideration of the total daily intake of acetaminophen from all sources is essential to prevent the risk of overdose and subsequent liver damage.

Healthcare providers should evaluate liver function prior to initiating treatment and consider appropriate dosage adjustments or alternative therapies for patients with known hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety during the course of treatment.

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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 safety profile 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, 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 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 with a doctor or pharmacist for clarification.

Patients should be instructed to discontinue use and seek medical advice if they experience any of the following: worsening pain that lasts more than 5 days, a fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

While using this product, patients must be cautioned against exceeding the recommended dosage, as this could lead to overdose. Additionally, healthcare providers should inquire about the child's medical history, specifically asking if the child has liver disease, as this may affect the safety of the medication. Furthermore, it is advisable to consult a doctor or pharmacist before use if the child is currently taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

The product is supplied with an enclosed dosing cup specifically designed for use with this formulation. It is essential to utilize only this dosing cup to ensure accurate dosing and optimal product performance.

Storage conditions require the product to be maintained at controlled room temperature, ideally between 20°C to 25°C (68°F to 77°F). It is important to protect the product from excessive heat, moisture, and direct sunlight to preserve its efficacy. Special handling precautions should be observed to prevent contamination and ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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