Childrens Pain Relief

Description

This product contains acetaminophen as the active ingredient, providing pain relief and fever reduction. Each 5 mL of the oral suspension delivers 160 mg of acetaminophen. It is formulated for children aged 2 to 11 years and is free from aspirin, alcohol, and ibuprofen. The product is presented in a grape-flavored oral suspension form.

The product is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension. It is packaged with a tamper-evident seal; do not use if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing.

Distributed by C.D.M.A. Inc., located at 43157 W. Nine Mile, Novi, MI 48376-0995. For more information, visit www.qualitychoice.com.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Dosage Chart:

• For patients weighing less than 24 lb or under 2 years of age, consultation with a doctor is advised.

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

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the maximum dosage and should monitor for any signs of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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 in this product, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, which can 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.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if a child exceeds five doses within a 24-hour period, which is the maximum recommended daily amount, or if acetaminophen is taken concurrently with other medications containing acetaminophen.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a physician promptly.

Patients should be advised to stop use and seek medical advice if any of the following occur: new symptoms arise, redness or swelling is observed, pain worsens or persists beyond five days, or fever intensifies or lasts more than three days. These symptoms may indicate a serious underlying condition.

In the case of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent. Quick intervention is vital for patient safety.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Severe skin reactions have been reported, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage if the product is used inappropriately. This risk is heightened if a patient exceeds five doses within a 24-hour period, which is the maximum daily amount, or if the product is taken concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a healthcare professional before using this product.

In clinical observations, patients have been advised to seek medical attention 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.

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

While using this product, it is crucial for patients to adhere to the recommended dosage to avoid overdose. Signs of overdose may include liver damage, and in such cases, immediate medical help should be sought or contact with a Poison Control Center should be made at 1-800-222-1222. Quick medical attention is essential, even if no symptoms are initially apparent.

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

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 arise from unintentional duplication of therapy. 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 (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive dosing based on weight. The following dosing chart is applicable:

• For patients under 24 lb (under 2 years), consultation with a doctor is advised.

• For patients weighing 24-35 lb (2-3 years), the recommended dose is 5 mL.

• For patients weighing 36-47 lb (4-5 years), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb (6-8 years), the recommended dose is 10 mL.

• For patients weighing 60-71 lb (9-10 years), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb (11 years), the recommended dose is 15 mL.

It is important to note that no more than 5 doses should be administered within a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare professional. Prior to use, consultation with a doctor is recommended if the pediatric patient has liver disease. Additionally, if the child is taking the blood-thinning medication warfarin, it is advisable to consult a doctor or pharmacist before administration.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is indicated for use in children aged 2 to 11 years, and there are no documented dosage adjustments or safety concerns specifically addressing the geriatric population.

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

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. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

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 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 five doses within a 24-hour period, as this is the maximum recommended daily amount.

In cases of overdose, which may occur if the recommended dosage is surpassed, there is a significant risk of liver damage. Patients are advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent. Prompt medical intervention is essential to mitigate potential liver injury.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately 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 signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate management procedures as necessary.

Potential Symptoms

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

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 rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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 be instructed to 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 cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

It is important 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 in the formulation. Additionally, patients should be instructed to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious condition.

Healthcare providers should remind patients to adhere strictly to the recommended dosage to avoid the risk of overdose. Furthermore, patients should be advised to consult a doctor before using this product if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential 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. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

No additional information is 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.

View product document (PDF)