Childrens Pain Relief

Description

Acetaminophen is provided in an oral suspension form, delivering 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer, specifically indicated for pediatric patients aged 2 to 11 years. The product is free from alcohol, aspirin, and ibuprofen, and features a cherry flavor for palatability.

It is important to note that this product is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension. The packaging includes a tamper-evident feature; the product should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. This product is made with pride and care for H-E-B®, located in San Antonio, TX 78204.

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 and age.

Before administration, the product must be shaken well. It is essential to use only the enclosed dosing cup specifically designed for this product; no other dosing devices should be utilized to ensure accurate dosing.

The recommended dosing intervals are as follows: if needed, 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.

The following dosage chart provides guidance based on weight and age:

• For patients weighing less than 24 lb and under 2 years of age, the dose is to be determined by a doctor.

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

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

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

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

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

Dosing may also be adjusted as directed by a healthcare professional. It is imperative to adhere to the maximum dosage recommendations and to consult a physician for any uncertainties regarding administration.

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 formulation, as this may lead to severe allergic reactions.

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

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should monitor for signs of liver injury, particularly in patients with pre-existing liver conditions or those taking multiple medications.

Acetaminophen is associated with the risk of severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, healthcare providers should be consulted without delay. These symptoms may indicate a more serious underlying condition.

Healthcare professionals should advise patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than 5 days, or if fever intensifies or persists beyond 3 days. These signs may suggest the presence of a serious condition requiring further evaluation.

In the event of an overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as prompt intervention is critical.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of more than 5 doses in 24 hours or who take the product in conjunction with other medications containing acetaminophen. Patients should be aware that acetaminophen can cause severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. It is advised that this product not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should also refrain from using this product if they have a known allergy to acetaminophen or any of the inactive ingredients.

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

While using this product, patients must adhere to the recommended dosage to avoid overdose, which may lead to liver damage. Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

In the case of an overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential even if no signs or symptoms are present.

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 and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. 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 this medication with specific dosing guidelines based on weight and age. For children weighing under 24 lb and under 2 years of age, consultation with a healthcare provider is advised prior to administration.

The recommended dosages for children aged 2 to 11 years are as follows:

• For those weighing 24-35 lb (ages 2-3 years): 5 mL

• For those weighing 36-47 lb (ages 4-5 years): 7.5 mL

• For those weighing 48-59 lb (ages 6-8 years): 10 mL

• For those weighing 60-71 lb (ages 9-10 years): 12.5 mL

• For those weighing 72-95 lb (age 11 years): 15 mL

Administration should not exceed 5 doses within a 24-hour period and should not be continued for more than 5 days unless directed by a healthcare provider.

Caution is advised; parents or guardians should consult a healthcare professional before use if the child has liver disease or is concurrently taking the anticoagulant warfarin.

Geriatric Use

The prescribing information for H-E-B Children's Pain Relief (acetaminophen suspension) does not provide specific guidance regarding the use of this medication in geriatric patients. There is no mention of dosage adjustments, safety concerns, or special precautions that should be considered when administering this medication to elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. It is advisable to monitor elderly patients closely for any adverse effects or unusual responses to treatment, as they may have different pharmacokinetic and pharmacodynamic profiles compared to younger populations.

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

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is critical to adhere to the recommended dosage, as exceeding this amount may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily limit. Additionally, caution is advised when this product is used concurrently with other medications containing acetaminophen, as this combination may also result in severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

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 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 timely intervention. Monitoring for any signs of hepatic impairment is advised in cases of suspected overdose.

In summary, healthcare providers should emphasize the importance 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

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 present in the formulation. Healthcare providers should instruct patients to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious underlying condition.

Patients should be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

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 schedule that allows for repeat doses 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)