Childrens Pain Relief

Description

NDC 68016-103-04. Premier Value® Children's Pain Relief is a pain reliever and fever reducer formulated with acetaminophen. This product is presented in a suspension drop dosage form, with a volume of 4 FL OZ (118 mL). It is alcohol-free, aspirin-free, and ibuprofen-free, featuring a cherry flavor. The formulation has been independently tested to ensure quality and efficacy.

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

This product is intended for use in pediatric patients, and specific dosing instructions must be followed carefully. Prior to administration, the product should be shaken well to ensure proper mixing.

Dosing should be determined using the chart provided below, with weight being the preferred method for calculating the dose. If weight is not available, age may be used as an alternative. It is imperative to use only the enclosed dosing cup designed for this product; other dosing devices should not be utilized.

The recommended dosing intervals are as follows: 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. Continuous use beyond 5 days should only occur under the guidance of a healthcare professional.

Dosage Chart:

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

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 teaspoon (5 mL).

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1½ teaspoons (7.5 mL).

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 teaspoons (10 mL).

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2½ teaspoons (12.5 mL).

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 teaspoons (15 mL).

Adherence to these guidelines is essential for safe and effective use of the product.

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

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

Additionally, it is imperative to adhere to the recommended dosage guidelines, as exceeding the advised amount poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within 24 hours or if they are concurrently using other medications that also contain acetaminophen.

In the event of a 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 healthcare professional promptly.

Healthcare professionals should advise parents or guardians to seek medical guidance before administering this product if the child has a history of liver disease. Additionally, it is crucial to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur. It is essential to adhere strictly to the recommended dosage and not exceed it during treatment.

In cases of accidental overdose, immediate professional assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Quick medical attention is vital, even if no signs or symptoms are initially apparent.

Parents or guardians should be instructed to discontinue use and consult 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 more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product, which contains acetaminophen. Specifically, taking more than 5 doses within a 24-hour period, or using it concurrently with other medications containing acetaminophen, significantly increases the risk of liver injury.

Patients should be advised to consult a doctor promptly if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms may indicate a serious condition.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should verify the presence of acetaminophen in other medications with a healthcare professional if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of its inactive ingredients.

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

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a healthcare provider if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, as these may be signs of a serious condition.

In the event of an overdose, which could lead to serious health complications including liver damage, immediate medical attention is essential. Patients should seek professional assistance or contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or non-prescription, 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 medication. This is important 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 Pain Relief (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 those aged 2 to 3 years weighing 24-35 lb, the recommended dose is 1 teaspoon (5 mL). For children aged 4 to 5 years weighing 36-47 lb, the dose is 1½ teaspoons (7.5 mL). For children aged 6 to 8 years weighing 48-59 lb, the dose is 2 teaspoons (10 mL). For those aged 9 to 10 years weighing 60-71 lb, the dose is 2½ teaspoons (12.5 mL), and for 11-year-olds weighing 72-95 lb, the dose is 3 teaspoons (15 mL).

It is critical to note that this product contains acetaminophen, and severe liver damage may occur if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount when combined with other acetaminophen-containing medications. Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Dosing should ideally be based on the child's weight; if weight is not available, age may be used. Only the enclosed dosing cup designed for this product should be utilized, and no other dosing devices should be employed. The product should not be administered more than 5 times in a 24-hour period or for more than 5 days unless directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance tailored to this population. Additionally, the absence of directions or complete warnings for adult use suggests that healthcare providers should exercise caution when considering this product for geriatric patients.

It is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of this product. Given the lack of specific data, dose adjustments may be necessary based on the clinical judgment of the healthcare provider, taking into account the overall health status and comorbidities of the geriatric patient.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

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, which contains acetaminophen. It is critical to adhere to the recommended dosing guidelines, as severe liver damage may occur if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. Additionally, patients should be aware that combining this product with other medications containing acetaminophen can also lead to severe liver damage.

Before initiating treatment, it is advisable for patients with compromised liver function to consult a healthcare professional. This is particularly important for those with existing liver disease, as the risk of adverse effects may be heightened.

Patients must be vigilant about not exceeding the recommended dose, as an overdose could result in serious health complications, including significant liver damage. Regular monitoring of liver function may be warranted in patients with hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, serious health complications may arise, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdosing.

In cases of accidental overdose, immediate action is essential. Healthcare providers should advise patients or caregivers to seek professional assistance without delay. Contacting a Poison Control Center at 1-800-222-1222 is strongly recommended to ensure appropriate guidance and intervention.

Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly mitigate the risk of severe health consequences and improve patient outcomes.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medication containing 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. 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.

When using this product, it is crucial to adhere to the recommended dosage and to be aware of the overdose warning. Healthcare providers should also recommend that patients consult a doctor prior to use if their child has liver disease. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied with a dosage cup included for accurate measurement. It should be stored at controlled room temperature to maintain its efficacy and stability. Proper handling is essential to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Continuous use should not extend beyond 5 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients are advised to discontinue use and seek medical advice 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 more than 3 days.

Drug Information (PDF)

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

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