Acetaminophen

Description

SPL Code 34089-3 corresponds to a formulation indicated for children's pain relief. This product is specifically designed to address pain management in pediatric patients, ensuring safety and efficacy in its application.

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, 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 based on the patient's weight; if weight is not available, age may be used as a secondary reference. The following dosing chart provides specific recommendations:

• For patients weighing under 24 lb (under 2 years of age), consult a physician for the appropriate dose.

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

• For patients weighing 36-47 lb (4-5 years of age), administer 7.5 mL (1 1/2 teaspoons).

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

• For patients weighing 60-71 lb (9-10 years of age), administer 12.5 mL (2 1/2 teaspoons).

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

Doses may be repeated every 4 hours as needed while symptoms persist, but do not exceed 5 doses in a 24-hour period. Treatment should not continue for more than 5 days unless directed by a physician.

It is essential to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be utilized.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this product.

• Exceeding the recommended dose is contraindicated, as it may lead to overdose and associated complications.

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 containing 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 inquire about any existing liver disease in pediatric patients prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, as rapid intervention is essential for both adults and children, even in the absence of overt symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if new symptoms arise, including redness or swelling, as these may indicate a serious medical condition requiring further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly if patients exceed the maximum daily amount of five doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Symptoms of liver damage may not be immediately apparent, making it crucial for patients to adhere strictly to dosing guidelines.

Allergic reactions, particularly severe skin reactions, have been reported. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. In such cases, it is recommended to consult a healthcare professional promptly.

It is important to note that this product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should avoid its use.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

While using this product, patients must not exceed the recommended dose. They should discontinue use and consult a healthcare professional if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In cases of overdose, which may lead to liver damage, immediate medical attention is critical. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are present, as prompt intervention is essential for both adults and children.

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 may be heightened, leading to serious hepatic complications. 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. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lb should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lb, the recommended dosage is 5 mL (1 tsp). For those aged 4 to 5 years weighing 36-47 lb, the dosage increases to 7.5 mL (1 1/2 tsp). Children aged 6 to 8 years weighing 48-59 lb should receive 10 mL (2 tsp), while those aged 9 to 10 years weighing 60-71 lb may take 12.5 mL (2 1/2 tsp). Finally, for children aged 11 years weighing 72-95 lb, the dosage is 15 mL (3 tsp).

Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if such reactions occur, use should be discontinued immediately, and medical help sought. Parents should be vigilant for severe sore throat symptoms that persist for more than 2 days or are accompanied by fever, headache, rash, nausea, or vomiting, and consult a doctor promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, nor in children who are allergic to acetaminophen or any inactive ingredients in the formulation. Prior to use, consultation with a doctor is advised if the child has liver disease or is taking the blood-thinning medication warfarin.

In the event of an overdose, which may lead to liver damage, immediate medical attention is critical. Parents should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

Dosing should primarily be based on weight; if weight is not available, age may be used as a guide. Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period or be administered for more than 5 days unless directed by a doctor.

Geriatric Use

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

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. The use of this product should be carefully considered, weighing the benefits against any potential risks.

Dosage adjustments may be necessary for pregnant patients; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate dosing. Additionally, special precautions should be taken to monitor for any adverse effects during pregnancy. Any adverse effects that occur should be reported to a healthcare provider immediately.

Lactation

Lactating mothers should 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.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of 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 be closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that patients with liver disease consult a healthcare professional. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Due to the potential for serious liver injury, careful consideration of dosage and vigilant monitoring of liver function are imperative in patients with compromised liver function.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms of overdose, as these may not always be immediately apparent.

Recommended Actions In the case of suspected overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is crucial, as quick medical attention can mitigate the risks associated with overdose for both adults and children.

Management Procedures Even in the absence of noticeable symptoms, it is essential to seek medical evaluation following an overdose. The potential for serious health consequences necessitates a thorough assessment and appropriate management to ensure patient safety and well-being.

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 postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of the medication. Patients must be informed that taking more than the recommended dose may lead to serious liver damage. In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are present.

Providers should emphasize that patients should not exceed the recommended dose to avoid the risk of overdose. Additionally, it is important to counsel parents or guardians to consult a healthcare professional before administering the medication to a child who has liver disease. Furthermore, patients should be advised to speak with their doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, as this may require special consideration.

Storage and Handling

The product is supplied in a carton that contains essential information for use. It is important to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Users are advised to retain the carton to access the full directions for use.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients 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 (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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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