Childrens Pain Relief Dye-Free

Description

This oral suspension contains acetaminophen at a concentration of 160 mg per 5 mL, serving as a pain reliever and fever reducer. It is formulated for children aged 2 to 11 years and is free from alcohol, aspirin, ibuprofen, and dyes. The product is presented in a grape flavor and is distributed by Winco Foods, LLC, Boise, ID 83704. This formulation is comparable to the active ingredient found in Children's TYLENOL® Oral Suspension; however, it is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's TYLENOL® Oral Suspension.

Uses and Indications

This drug is indicated for the temporary 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 should be shaken well before use. Administration is to be performed using only the enclosed dosing cup specifically designed for this product; the use of any other dosing device is not recommended.

Dosing is determined primarily by weight; however, age may be used as an alternative if weight is not available. The following dosing chart provides the recommended doses:

• For patients weighing under 24 lbs or under 2 years of age, consult a doctor for appropriate dosing.

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

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

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

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

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

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a healthcare professional.

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. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose 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 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.

Severe skin reactions have been associated with acetaminophen use. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

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, prompt consultation with a healthcare provider is recommended.

General precautions should be observed. Caregivers are advised to consult a physician prior to administration if the child has a history of liver disease. Furthermore, it is essential to seek guidance from a healthcare professional or pharmacist if the child is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Caregivers should contact a poison control center (1-800-222-1222) or seek emergency medical help without delay, regardless of whether symptoms are present.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child experiences any of the following: worsening pain that lasts more than five days, a fever that worsens or persists for more than three days, the presence of redness or swelling, or the emergence of new symptoms. These may indicate a serious underlying condition that requires further evaluation.

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 amount of acetaminophen, which is defined as more than 5 doses within a 24-hour period, or if the product is taken concurrently with other medications containing acetaminophen. In cases of overdose, immediate medical attention is critical, as liver damage can occur even in the absence of noticeable symptoms. Patients are advised to contact a poison control center or seek medical help without delay if an overdose is suspected.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use and seek medical assistance promptly.

Patients should also be vigilant regarding 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, it is essential to consult a healthcare provider.

Patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, or if new symptoms develop. These may indicate a serious underlying condition that requires medical evaluation.

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 Pain Relief Dye-Free (acteaminophen). 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 11 years, dosing is weight-based as follows:

• For those weighing 24-35 lbs (2-3 years), the recommended dose is 5 mL.

• For children weighing 36-47 lbs (4-5 years), the dose is 7.5 mL.

• For those weighing 48-59 lbs (6-8 years), the dose is 10 mL.

• For children weighing 60-71 lbs (9-10 years), the dose is 12.5 mL.

• For those weighing 72-95 lbs (11 years), the dose is 15 mL.

It is important not to exceed 5 doses in a 24-hour period and not to administer the medication for more than 5 days unless directed by a doctor.

Caution is advised for pediatric patients with liver disease; a doctor should be consulted before use. Additionally, if the child is taking the blood-thinning medication warfarin, consultation with a doctor or pharmacist is recommended. Parents and caregivers should ensure that the medication is kept out of reach of children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety may be warranted, given the general variability in drug response among elderly individuals.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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 prescribing information 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 important to adhere strictly to the recommended dosage, as exceeding this may result in liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a poison control center is advised. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose and the potential for significant health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a poison control center without delay. Quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can be vital in mitigating the risks associated with overdose and ensuring patient safety.

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 specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Patients must be reminded to adhere strictly to the recommended dosage and to be vigilant for any signs that may necessitate discontinuation of the product. They should be instructed to stop use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise, as these may indicate a serious underlying condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which can be found on the label. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional.

Patients should be counseled to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately, as prompt medical attention is essential even if no symptoms are apparent.

Drug Information (PDF)

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

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