Pain Reliever

Description

Acetaminophen is formulated as an oral suspension containing 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 or contraindications. The oral suspension is presented in a cherry flavor to enhance palatability for the intended age group.

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 specific populations, and healthcare professionals should refer to the dosage chart for appropriate dosing. It is essential to shake the product well before use. The enclosed dosing cup designed for this product must be utilized; no other dosing devices should be employed to ensure accurate dosing.

Dosing should be determined primarily by weight; however, age may be used as an alternative if weight is not available. The following dosing recommendations apply:

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

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

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

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

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

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a healthcare professional. It is imperative to adhere to these guidelines to avoid the risk 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, 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 risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than 5 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 may also trigger severe skin reactions. Symptoms indicative of such reactions 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, 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: new symptoms arise, redness or swelling is observed, pain worsens or persists beyond 5 days, or fever intensifies or lasts more than 3 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 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 patient safety.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients are advised to consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

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

While using this product, it is crucial not to exceed the recommended dosage. 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.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised. Quick medical attention is critical, even if no signs or symptoms are immediately 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 Reliever (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 doctor is advised prior to use. The recommended dosages for children in the following weight ranges 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 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.

Healthcare providers should exercise caution and consult a doctor if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 data precludes definitive conclusions about its use in this population.

Given the lack of information on potential fetal impacts, healthcare providers are advised to consider the risks and benefits of acetaminophen use in women of childbearing potential. It is essential to evaluate the necessity of treatment against any potential unknown risks to fetal outcomes. Further research may be required to establish safety profiles and appropriate dosage modifications for pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

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 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 liver damage early.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. It is essential for healthcare professionals to be aware of the potential severity of an overdose and the importance of prompt intervention.

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 critical, even if the patient does not exhibit any 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 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 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 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.

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.

While using this product, patients must be reminded not to exceed the recommended dosage, in line with 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 packaging that includes specific NDC numbers, which can be referenced for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. For traceability, the lot number and expiration date can be found 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 the option to repeat the dose 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.

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.

View product document (PDF)