Pain Relief

Description

Acetaminophen is formulated as an oral suspension, providing 160 mg of acetaminophen per 5 mL. This medication is indicated for use in pediatric patients aged 2 to 11 years. The formulation is free from aspirin, alcohol, and ibuprofen, making it suitable for children with specific sensitivities. The product is presented in a cherry flavor to enhance palatability.

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 used; 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 under 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.

Dosing should be adjusted as directed by a healthcare professional. It is imperative to adhere to the maximum dosage limits and duration of use to avoid potential 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, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

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

Additionally, exceeding the recommended dosage is contraindicated due to the risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is recommended.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: the emergence of new symptoms, the presence of redness or swelling, worsening pain lasting more than five days, or a fever that worsens or persists beyond three days. These symptoms may indicate a serious underlying condition that requires further evaluation.

In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential for optimal outcomes.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if more than five doses are taken within a 24-hour period or if it is used concurrently 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 two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. It is advised that patients do not use this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, and should verify the contents of any other medications with a doctor or pharmacist if uncertain.

Patients with a history of liver disease should consult a doctor before using this product. Additionally, those taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist prior to use.

While using this product, patients must adhere strictly to the recommended dosage to avoid the risk of overdose. If new symptoms arise, or if there is any redness or swelling, or if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, patients should discontinue use and consult a doctor, as these may indicate a serious condition.

In cases of overdose, which may lead to liver damage, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent.

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 be heightened, leading to serious hepatic complications. 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 this medication with specific dosing guidelines based on weight and age. For children weighing under 24 lb (under 2 years), consultation with a healthcare provider is advised prior to use. The recommended dosages for children aged 2 to 11 years are as follows:

• 24-35 lb (2-3 years): 5 mL

• 36-47 lb (4-5 years): 7.5 mL

• 48-59 lb (6-8 years): 10 mL

• 60-71 lb (9-10 years): 12.5 mL

• 72-95 lb (11 years): 15 mL

It is important to limit administration to no more than 5 doses within a 24-hour period and to not exceed 5 consecutive days of use unless directed by a healthcare professional.

Healthcare providers should be consulted before use if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin. Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions, including symptoms such as skin reddening, blisters, or rash. In the event of a skin reaction, use should be discontinued immediately, and medical assistance should be sought.

Geriatric Use

Elderly patients may not receive comprehensive guidance or warnings regarding the use of this product, as the labeling does not include specific directions for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the absence of detailed information may impact the safety and efficacy of treatment in this population. It is advisable to closely monitor elderly patients for any adverse effects and to consider potential dose adjustments based on individual patient needs and responses.

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 acetaminophen to pregnant patients, as the absence of safety concerns, dosage modifications, or special precautions leaves a gap in the understanding of its potential effects on fetal outcomes.

Given the lack of comprehensive data, it is advisable for healthcare providers to weigh the benefits against any potential risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to establish clearer guidelines and safety profiles for the use of acetaminophen during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if there is a history of liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment. Careful evaluation is necessary to ensure safe and effective use in this population.

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 recommended 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 advised, as prompt medical attention is critical, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdose.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention is crucial, even if the patient does not exhibit any noticeable signs or symptoms of overdose. Early intervention can significantly impact the outcome and mitigate potential complications associated with liver damage.

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 be instructed to seek medical help or contact a Poison Control Center immediately 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 beyond five days, or if fever intensifies or lasts more 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 anticoagulant medication warfarin, as these factors may influence the safety and efficacy of the treatment.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which can be referenced by the National Drug Code (NDC) numbers provided on the label. It is essential to store the product at a controlled room temperature between 20º-25ºC (68º-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product.

Healthcare professionals should ensure that the lot number and expiration date are verified, as these details are located on the bottom panel of the packaging. Prior to administration, the product must be shaken well to ensure proper mixing. It is crucial to use only the enclosed dosing cup that is specifically designed for this product; the use of any other dosing device is not recommended to ensure accurate dosing 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 Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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