Childrens Pain Relief Dye-Free

Description

Childrens Pain Relief Oral Suspension is formulated to provide effective pain relief and fever reduction, containing acetaminophen at a concentration of 160 mg per 5 mL. This product is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for children aged 2 to 11 years. The suspension is dye-free and features a cherry flavor for palatability. Each bottle contains 4 FL OZ (118 mL) of the oral suspension, ensuring accurate dosing for pediatric use.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It also provides relief from minor aches and pains associated with various conditions, including the common cold, sore throat, influenza, toothache, and headache.

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

Dosage and Administration

Healthcare professionals should administer this product according to the following guidelines. It is essential to shake the product well before use. The enclosed dosing cup must be utilized for accurate measurement.

Dosing should be determined primarily by weight; however, age may be used as an alternative if weight is not available. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The dosing chart is as follows:

• For patients weighing under 24 lbs or under 2 years of age, the dose should be determined by consulting a doctor.

• 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.

It is critical not to exceed the recommended dosage, as outlined in the overdose warning.

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. Consultation with a healthcare professional is advised if there is uncertainty regarding other medications.

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

Additionally, it is imperative to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance or contact with a poison control center is essential, regardless of the presence of symptoms.

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

Warnings and Precautions

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

In the event of a severe sore throat that persists for more than two days or 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, particularly regarding liver disease, before recommending this product. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In cases of overdose, immediate medical assistance should be sought, or a poison control center should be contacted without delay. Rapid medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: worsening pain that lasts more than five days, worsening fever that lasts more than three days, the presence of redness or swelling, or the emergence of new symptoms. These signs 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 is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with liver disease should consult a doctor before using this product. Additionally, caution is advised for patients taking the blood-thinning medication warfarin; they should seek guidance from a healthcare professional prior to use.

In the event of a sore throat, patients are advised to consult a doctor if the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Patients should discontinue use and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if redness or swelling occurs, or if new symptoms develop, as these may indicate a serious condition.

Overdose of this product can lead to liver damage. Patients must not exceed the recommended dose, and in the case of an overdose, immediate medical assistance should be sought or a poison control center contacted. Quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

It is also important to note that this product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, and should not be administered to individuals with known allergies to acetaminophen or any inactive ingredients in the formulation.

Drug Interactions

Co-administration of this medication with other drugs should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication alongside any other drugs, particularly if there is uncertainty regarding potential interactions.

This medication should not be used concurrently with any other products containing acetaminophen, whether they are prescription or non-prescription. The risk of acetaminophen overdose may increase, leading to serious adverse effects.

Additionally, it is recommended that healthcare providers be consulted before administering this medication to children who are concurrently taking warfarin, a blood-thinning agent. Monitoring of coagulation parameters may be necessary to ensure safe and effective use.

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 aged 2 to 11 years may receive this medication according to the following dosing chart based on weight and age:

• Under 24 lbs: Under 2 years: Consult a doctor.

• 24-35 lbs: 2-3 years: 5 mL.

• 36-47 lbs: 4-5 years: 7.5 mL.

• 48-59 lbs: 6-8 years: 10 mL.

• 60-71 lbs: 9-10 years: 12.5 mL.

• 72-95 lbs: 11 years: 15 mL.

It is important not to exceed 5 doses in a 24-hour period, as this is the maximum daily amount for children. Healthcare professionals should advise parents or guardians to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin prior to use.

Overdose may lead to liver damage; therefore, it is crucial to adhere strictly to the recommended dosing. Parents should be instructed to 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 there is any redness or swelling, or if new symptoms arise.

Geriatric Use

Elderly patients have not been specifically studied in relation to the use of this product, and no specific information regarding geriatric use is provided in the prescribing information. The product is indicated for pediatric patients aged 2 to 11 years, and there are no dosage adjustments or safety concerns outlined for geriatric patients.

Healthcare providers should exercise caution when prescribing this product to elderly patients, considering the lack of data on its safety and efficacy in this population. Monitoring for potential adverse effects may be warranted, given the absence of established guidelines for geriatric use.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered in the absence of established safety profiles during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 maximum daily dosage of 5 doses within a 24-hour period is exceeded.

It is crucial to adhere strictly to the recommended dosing guidelines, as an overdose may lead to significant liver damage. In the event of an overdose, immediate medical assistance should be sought, or a poison control center should be contacted without delay. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

Taking more than the recommended dose of the medication may lead to significant 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 of overdose.

Healthcare professionals should be vigilant in monitoring patients for any potential symptoms associated with overdose, although specific symptoms are not detailed in the provided information. The importance of rapid response cannot be overstated, as timely management can mitigate the risk of severe complications.

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.

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 noted in patients taking acetaminophen, particularly among those with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been documented following the administration of acetaminophen. Furthermore, there have been reports of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing kidney conditions.

Patient Counseling

Healthcare providers should advise patients to avoid using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain about the use of other medications alongside this product.

It is essential 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 contained within the formulation. Additionally, healthcare providers should recommend that patients seek medical advice before using this product if their child has a history of liver disease.

Patients should also be counseled to consult a doctor or pharmacist prior to use if their child is currently taking the anticoagulant medication warfarin, as interactions may occur.

When using this product, patients must be instructed not to exceed the recommended dosage, as doing so may lead to serious health risks. Healthcare providers should emphasize the importance of monitoring for specific symptoms and advise patients to discontinue use and seek medical attention if any of the following occur: worsening pain that lasts more than five days, a fever that persists for more than three days, the presence of redness or swelling, or the emergence of new symptoms. These signs may indicate a serious underlying condition that requires prompt evaluation.

Patients should be made aware of the overdose warning associated with this product. Taking more than the recommended dose can result in liver damage, and in the event of an overdose, immediate medical assistance should be sought or contact with a poison control center should be made. Quick medical attention is crucial for both adults and children, even if no immediate signs or symptoms are apparent.

Finally, healthcare providers should remind patients to keep this product out of reach of children to prevent accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children. It is advised to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients should discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if there is any redness or swelling, or if new symptoms arise.

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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