Pain Relief

Description

Children's Pain Relief is an oral suspension formulation containing acetaminophen at a concentration of 160 mg per 5 mL. This product serves as a pain reliever and fever reducer, specifically designed for children aged 2 to 11 years. It is alcohol-free, aspirin-free, and ibuprofen-free, and features a grape flavor without added dyes. The product is manufactured with a tamper-evident seal; it 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 formulation is made with pride and care for H-E-B®, located in San Antonio, TX 78204. 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.

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 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 every 4 hours as needed 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, the dose should be determined by consulting a doctor.

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

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

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

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

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

Dosing should be adjusted as necessary and always in accordance with a healthcare provider's guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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 dosage guidelines, as exceeding the recommended dose may lead to serious health risks, including overdose.

Warnings and Precautions

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

Acetaminophen has been associated with 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 two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Prior to administration, it is essential to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek advice from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

While using this product, it is critical not to exceed the recommended dosage. Caregivers should be vigilant and discontinue use 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. These symptoms may indicate a serious underlying condition that requires medical evaluation.

An overdose warning is pertinent, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, immediate medical attention is necessary. 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 crucial.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the medication concurrently with other drugs containing acetaminophen. In cases of overdose, which involves taking more than the recommended dose, patients may experience liver damage. Immediate medical assistance is crucial, and individuals should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. If any skin reaction occurs, it is imperative to discontinue use and seek medical help immediately.

In addition, patients should consult a doctor 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. These symptoms may indicate a serious condition that requires prompt medical evaluation.

Patients are advised to stop use and seek medical advice if new symptoms arise, if redness or swelling is observed, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days. These could be indicative of a serious underlying 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 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 and age. The recommended dosages are as follows: for children weighing under 24 lb and under 2 years of age, consultation with a doctor is advised. For those weighing 24-35 lb (ages 2-3 years), the dosage is 5 mL; for 36-47 lb (ages 4-5 years), 7.5 mL; for 48-59 lb (ages 6-8 years), 10 mL; for 60-71 lb (ages 9-10 years), 12.5 mL; and for 72-95 lb (age 11 years), 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 child has liver disease. Additionally, if the child is taking the anticoagulant warfarin, it is advisable to seek guidance from a doctor or pharmacist before administration.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the drug insert does not provide guidance on geriatric use. The product is indicated for children aged 2 to 11 years, and there are no documented dosage adjustments or safety considerations specifically for 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. Monitoring for potential adverse effects is advisable, as the pharmacokinetics and pharmacodynamics may differ in elderly patients compared to younger populations.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are thoroughly evaluated.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers.

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 be closely monitored when using this product, which contains acetaminophen. It is important 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 this product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought. Contacting a Poison Control Center at 1-800-222-1222 is recommended, as prompt medical attention is critical, even if no signs or symptoms of liver damage are apparent.

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, the potential for serious health consequences necessitates immediate action in the event of an overdose, emphasizing the need for healthcare professionals to remain alert and responsive to such situations.

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 provided in the insert.

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 also 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.

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 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, not to exceed 5 doses within a 24-hour period. Additionally, it should not be used for more than 5 consecutive days unless directed by a healthcare professional.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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