Pain Reliever

Description

Acetaminophen is formulated as an oral suspension containing 160 mg of acetaminophen per 5 mL. This preparation serves as a pain reliever and fever reducer, specifically designed for pediatric use in children aged 2 to 11 years. The product is alcohol-free, aspirin-free, and ibuprofen-free, ensuring a safer option for this age group. It is presented in a grape flavor to enhance palatability. A dosage cup is provided for accurate administration. 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.

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 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, the dose should be determined by consulting a doctor.

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

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the maximum dosage and should provide guidance on the importance of adhering to the recommended dosing schedule.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to serious health risks.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen may also lead to 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

Healthcare providers should inquire about the presence of liver disease before recommending this product for children. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no symptoms are 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 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious underlying condition.

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 recommended dosage 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, as these may indicate a more serious condition requiring prompt medical consultation.

It is important to note that this product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients with known allergies to acetaminophen or any inactive ingredients in this product should avoid its use. Additionally, individuals with liver disease or those taking the blood-thinning medication warfarin should consult a healthcare professional before using this product.

During use, patients should not exceed the recommended dosage. They should discontinue use and consult a doctor 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 be signs of a serious condition.

In cases of overdose, which may lead to liver damage, immediate medical attention is essential. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present, as prompt intervention is critical.

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 Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

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

It is important to note that no more than 5 doses should be administered within a 24-hour period, and use should not exceed 5 days unless directed by a healthcare professional.

Safety concerns include the risk of severe liver damage if the child exceeds 5 doses in 24 hours or if used concurrently with other medications containing acetaminophen. Additionally, there is an allergy alert for acetaminophen, which may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Parents should consult a doctor if the child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

Precautions should be taken to consult a doctor before use if the child has liver disease. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the child is taking the blood-thinning medication warfarin.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

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 adequately assessed.

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, as the effects on the nursing infant are not fully understood.

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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of overdose and subsequent liver injury.

Before initiating treatment, it is advisable for patients with liver disease to consult a healthcare professional. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the severity of hepatic impairment. Regular monitoring of liver function may be warranted in these patients to detect any signs of hepatotoxicity early.

Overdosage

Taking more than the recommended dose of the 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.

Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose. Healthcare professionals should be aware that early intervention can significantly impact the outcome in cases of suspected 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 that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain 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 to avoid using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, patients should be advised 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 dosage. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease or is currently taking the anticoagulant medication warfarin, as these factors may influence the safety and efficacy of the treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25 ºC (68-77 ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Continuous use should not extend beyond 5 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients are advised to discontinue use and seek medical advice if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

Drug Information (PDF)

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

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