Family Wellness Childrens Pain Reliever 574

Description

Acetaminophen is presented as an oral suspension liquid, containing 160 mg of acetaminophen per 5 mL. The formulation is flavored with cherry and is packaged in a 4 FL OZ (118 mL) container.

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, sore throat, influenza, toothache, and headache.

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

Dosage and Administration

Healthcare professionals are advised to administer this product according to the following guidelines. It is imperative to shake the product well before use. The dosing should be performed using only the enclosed dosing cup to ensure accuracy.

The recommended dosing intervals are every 4 hours while symptoms persist. It is crucial not to exceed the directed dosage, and healthcare providers should refer to the overdose warning for further guidance.

For determining the appropriate dose, practitioners should consult the dosage chart below. If possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a secondary reference.

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

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

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

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

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

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

It is essential to adhere strictly to these guidelines to ensure safe and effective use of the product.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other product containing acetaminophen, whether prescription or non-prescription, is prohibited. Consultation with a healthcare professional is advised before using this product in conjunction with other medications.

• 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 five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, 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 is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should be vigilant regarding the potential for overdose, which can lead to significant liver damage. In the event of an overdose, immediate medical attention is crucial, and caregivers should be instructed to contact a Poison Control Center without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a physician if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling. These symptoms may indicate a serious medical 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 dosage of five doses within a 24-hour period or who take this product concurrently with other medications containing acetaminophen. It is crucial for patients to adhere to the recommended dosage to mitigate the risk of liver injury.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients should also be instructed to stop use and contact 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 there is any redness or swelling, as these may indicate a serious underlying condition.

Before using this product, it is recommended that patients with liver disease consult a healthcare provider. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Childrens Pain Reliever 574 (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lbs should be advised to consult a doctor before use. For children aged 2 to 3 years weighing between 24-35 lbs, the recommended dose is 5 mL. For those aged 4 to 5 years weighing 36-47 lbs, the dose increases to 7.5 mL. Children aged 6 to 8 years weighing 48-59 lbs should receive 10 mL, while those aged 9 to 10 years weighing 60-71 lbs may take 12.5 mL. Finally, for children aged 11 years weighing 72-95 lbs, the recommended dose is 15 mL.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. It is contraindicated to use this product in conjunction with any other acetaminophen-containing medications, whether prescription or non-prescription, and it should not be administered to children with a known allergy to acetaminophen or any inactive ingredients in the formulation.

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. 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 new symptoms arise, or if there is any redness or swelling.

It is critical to keep this medication out of reach of children. An overdose may lead to liver damage, and immediate medical attention should be sought in such cases, even if no symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this medication. Pregnant patients are advised to consult a healthcare provider before use. Additionally, it is important to seek medical advice if breastfeeding, as the effects on nursing infants are also not well characterized. Given the lack of established safety data, caution is warranted when considering the use of this medication in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the absence of contraindications when advising lactating mothers. Further clinical judgment should be applied based on individual circumstances.

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 be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical to adhere to the recommended dosage guidelines, as exceeding 5 doses within a 24-hour period may lead to significant hepatic injury. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen to mitigate the risk of liver toxicity. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy of treatment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose, ensuring that appropriate interventions are implemented based on the patient's condition.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, reports indicate that exceeding the recommended dosage of acetaminophen may lead to liver damage. In cases of overdose, prompt medical attention is essential, and individuals are encouraged to contact a Poison Control Center, even if no signs or symptoms are present.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of the medication, as exceeding this dosage may lead to liver damage. In the event of an overdose, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial even if no symptoms are apparent.

Patients should be encouraged to consult with a healthcare professional or pharmacist before using this medication in conjunction with other drugs, particularly if they are uncertain about potential interactions. It is essential to inquire about the patient's medical history, especially if the patient is a child with liver disease or is currently taking the blood-thinning medication warfarin.

Patients should be instructed to discontinue use and consult a healthcare provider if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, or if any new symptoms arise. Additionally, the presence of redness or swelling should prompt immediate consultation with a healthcare professional, as these may indicate a serious condition.

Finally, it is critical to inform patients that this medication should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the product.

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 between 20-25ºC (68-77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Family Wellness Childrens Pain Reliever 574, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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