Childrens Pain Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for use in accordance with the dosing guidelines provided. Healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician before administration. For those weighing between 24 to 35 pounds, the recommended dose is 1 tablet. Patients weighing 36 to 47 pounds should receive 1 ½ tablets, while those weighing 48 to 59 pounds should be given 2 tablets. For patients weighing 60 to 71 pounds, the dose is 2 ½ tablets, and for those weighing 72 to 95 pounds, the recommended dose is 3 tablets.

In terms of age-based dosing, children aged 2 to 3 years should receive 1 tablet, while those aged 4 to 5 years should be given 1 ½ tablets. For children aged 6 to 8 years, the dose is 2 tablets, and for those aged 9 to 10 years, 2 ½ tablets are recommended. Children aged 11 years should receive 3 tablets.

Patients should chew the tablet thoroughly before swallowing. If symptoms persist, the dose may be repeated every 4 hours as needed, but it is crucial not to exceed 5 doses within a 24-hour period. It is imperative to adhere strictly to the recommended dosing guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

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

Additionally, it is essential to adhere to the recommended dosing guidelines, as exceeding the recommended dose may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

Healthcare providers should advise patients to discontinue use and seek medical advice if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

An overdose of acetaminophen can lead to significant liver damage. In the event of an overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center at 1-800-222-1222, even if they do not exhibit any immediate signs or symptoms of overdose, as prompt intervention is critical.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate cessation of the product and prompt medical attention are necessary.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this formulation should refrain from use.

Before administering this product, it is advisable to consult a healthcare provider if the patient has a history of liver disease or is currently taking the anticoagulant warfarin.

During the use of this product, patients must adhere to the recommended dosage to avoid overdose, which poses a significant risk of liver damage. Patients should discontinue use and seek medical advice 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, as these may indicate a serious underlying condition.

In cases of overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222. Timely medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. The combination may lead to potential interactions that could affect the efficacy and safety of warfarin therapy.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen. Therefore, routine monitoring or dosage adjustments are not specified beyond the aforementioned consideration with warfarin.

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 aged 2 to 11 years may use this medication, with specific dosing recommendations based on age. For children under 2 years, consultation with a doctor is advised prior to administration. The recommended dosages are as follows: for ages 2-3 years, 1 tablet; for ages 4-5 years, 1 ½ tablets; for ages 6-8 years, 2 tablets; for ages 9-10 years, 2 ½ tablets; and for age 11 years, 3 tablets. The maximum daily dose should not exceed 5 doses within a 24-hour period.

Administration requires that the tablets be chewed before swallowing, and if necessary, doses may be repeated every 4 hours while symptoms persist.

Healthcare professionals should be aware of several warnings associated with this medication. There is a risk of severe liver damage if the maximum daily amount is exceeded or if the medication is taken concurrently with other products containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If a patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

It is crucial to consult a doctor before use if the pediatric patient has liver disease or is taking the anticoagulant warfarin. An overdose may lead to liver damage; in such cases, immediate medical assistance or contact with a Poison Control Center is essential.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of data may necessitate careful monitoring and individualized assessment of treatment risks and benefits in this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients should be aware that there may be potential risks to the fetus, and it is essential to consult a healthcare provider for personalized advice. Acetaminophen is contraindicated in pregnancy for patients with a known hypersensitivity to acetaminophen or any of the inactive ingredients in this product.

Dosage adjustments may be necessary during pregnancy; therefore, healthcare providers should be consulted for specific recommendations. It is strongly advised that pregnant women seek medical advice before using this product to ensure the safety and well-being of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 lack of data 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. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical, even if no signs or symptoms of overdose are present.

Due to the potential for serious liver damage, careful consideration and monitoring of liver function are advised for patients with compromised liver function.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial, even if the individual does not exhibit any noticeable signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate interventions as necessary.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and timely response in suspected cases of overdose.

In summary, healthcare providers should emphasize the significance of adhering to the recommended dosage and the necessity of immediate action in the event of an overdose to mitigate potential health risks.

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 the potential for severe skin reactions associated with acetaminophen use. Reports indicate that symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there is a warning regarding the risk of liver damage associated with overdose. Taking more than the recommended dose may lead to serious health consequences. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222, as timely medical intervention is essential, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dose, reiterating the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a carton that contains essential labeling information, including the expiration date and lot number, which can be found on the end flap. It is important to store the product at room temperature, ensuring that it is kept away from high humidity to maintain its integrity. Healthcare professionals are advised to retain the carton for future reference regarding the full labeling details.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential 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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