Childrens Pain Relief

Description

NDC 68016-141-04. Premier Value® Children's Pain Relief is a suspension liquid formulation containing acetaminophen as the active ingredient. This product serves as a pain reliever and fever reducer. It is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for pediatric use. The formulation is presented in a grape flavor and is available in a 4 FL OZ (118 mL) bottle. The product has been independently tested, and satisfaction is guaranteed.

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

Shake the product well before use. Healthcare professionals should determine the appropriate dose using the dosing chart provided below. When possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a secondary reference.

Only the enclosed dosing cup designed for use with this product should be utilized for measuring doses. Other dosing devices are not recommended.

The following dosing recommendations apply:

• For patients weighing under 24 lb or under 2 years of age, consult a doctor before administration.

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

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

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

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

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

If necessary, doses may be repeated every 4 hours while symptoms persist. However, do not exceed 5 doses in a 24-hour period. Additionally, do not administer the product for more than 5 consecutive days unless directed by a healthcare professional.

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 other medications, 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 within the formulation.

• Exceeding the recommended dosage is contraindicated due to the 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 dosage of 5 doses within a 24-hour period 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 providers should inquire about the child’s medical history before recommending this product, particularly if the child has a history of liver disease. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant medication warfarin, as interactions may occur.

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 crucial, even if no signs or symptoms are initially apparent.

Patients should 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 more than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 with liver disease should consult a doctor before using this product. Additionally, the use of this product is contraindicated in patients who are allergic to acetaminophen or any of the inactive ingredients.

Participants should be advised to seek medical attention if they experience a severe sore throat that persists for more than 2 days, especially if accompanied by fever, headache, rash, nausea, or vomiting.

While using this product, it is crucial not to exceed the recommended dosage, as doing so could lead to serious health issues, including liver damage. In the event of an overdose, which may not present immediate symptoms, patients should seek professional assistance or contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is essential.

Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

Furthermore, it is advisable to consult a doctor or pharmacist before use if the child is taking the blood-thinning medication warfarin, to avoid potential interactions.

Drug Interactions

Concurrent use 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 administration if the child is concurrently taking warfarin, a blood-thinning agent. This is essential to ensure appropriate monitoring and to mitigate the risk of potential interactions that may 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 not be given this medication without consulting a doctor. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 1 teaspoon (5 mL). For those aged 4 to 5 years and weighing 36 to 47 pounds, the dose increases to 1½ teaspoons (7.5 mL). Children aged 6 to 8 years, weighing 48 to 59 pounds, should receive 2 teaspoons (10 mL), while those aged 9 to 10 years and weighing 60 to 71 pounds may take 2½ teaspoons (12.5 mL). Finally, for children aged 11 years weighing 72 to 95 pounds, the recommended dose is 3 teaspoons (15 mL).

Healthcare professionals should advise parents to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin.

It is critical to adhere to the recommended dosing guidelines, as exceeding the prescribed dose may lead to serious health issues, including liver damage. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted, even if no symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with acetaminophen use during pregnancy. Further research may be necessary to fully understand the implications of acetaminophen exposure in this population.

Lactation

Nursing mothers are advised to consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of this product on a nursing infant are not well studied. Therefore, caution is advised when considering the use of this product during lactation.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the patient exceeds the maximum recommended dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen.

It is crucial to adhere strictly to the recommended dosing guidelines, as an overdose may lead to serious health complications, including liver damage. In the event of an accidental overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 or seek professional assistance without delay, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of the medication can lead to serious health complications, including potential liver damage. It is essential for healthcare professionals to be aware of the risks associated with overdosage and to act promptly.

In the event of an accidental overdose, it is imperative to seek professional assistance immediately. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Quick medical attention is crucial, even if the individual does not exhibit any immediate signs or symptoms of overdose. Early intervention can significantly impact the outcome and mitigate the risk of severe health issues.

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 rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases resulting in liver transplant or death, particularly among patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been cases of renal impairment and acute kidney injury associated with the use of acetaminophen.

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 that contains 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, or if there is any redness or swelling observed. Additionally, patients should be made aware that if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, they should stop using the product and consult a healthcare professional, as these may indicate a serious condition.

When using this medication, it is crucial to adhere to the recommended dosage and to be aware of the overdose warning. Patients should also be advised to consult a doctor prior to use if their child has liver disease. Furthermore, it is recommended that patients speak with a doctor or pharmacist before administering this product if the child is currently taking the blood-thinning medication warfarin.

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 product remains within the recommended storage conditions.

Additional Clinical Information

The medication is administered orally, with the option to repeat the 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 do not continue treatment for more than 5 days unless specifically directed by a healthcare provider.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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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