Pain Relief

Description

Acetaminophen is formulated as an oral suspension containing 160 mg of acetaminophen per 5 mL. This product is intended for use in pediatric patients aged 2 to 11 years. It is free from aspirin, alcohol, ibuprofen, and dyes, and is flavored with grape. The formulation is designed to be tamper evident; 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.

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 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 and not to administer the product for more than 5 consecutive days unless directed by a physician.

The dosage chart is as follows:

• For patients weighing less than 24 lb or under 2 years of age, consult a doctor for appropriate dosing.

• 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 should be adjusted as directed by a healthcare professional when necessary.

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 product, as this may lead to severe allergic reactions.

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

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should monitor for signs of liver injury and educate caregivers about the importance of adhering to dosing guidelines.

Acetaminophen has been associated with severe skin reactions, which may 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. Healthcare providers should remain vigilant for these potential adverse effects and advise patients to report any such symptoms without delay.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a physician promptly. This may indicate a more serious underlying condition that requires further evaluation.

Before administering this product, healthcare professionals should inquire about any existing liver disease in the child. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as interactions may occur.

In the event of an overdose, immediate medical attention is critical. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and consult a healthcare provider 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 condition that necessitates further medical evaluation.

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 are advised to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription, and to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should 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, patients are advised to consult a doctor promptly.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dose. Patients should stop use and consult a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also present; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical even if no signs or symptoms are initially 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 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 Pain Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years are indicated for the use of this product. The recommended dosing is based on weight and age as follows: for children under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (ages 2-3 years), the dose is 5 mL; for 36-47 lb (ages 4-5 years), the dose is 7.5 mL; for 48-59 lb (ages 6-8 years), the dose is 10 mL; for 60-71 lb (ages 9-10 years), the dose is 12.5 mL; and for 72-95 lb (age 11 years), the dose is 15 mL.

It is important not to exceed 5 doses in a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional. Prior to administration, consultation with a doctor is recommended if the child has liver disease or is taking the anticoagulant warfarin.

Healthcare professionals should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any skin reaction occurs, the product should be discontinued, and medical assistance sought immediately. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a doctor is advised.

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.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when considering acetaminophen for pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use 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. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Therefore, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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 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 allowance. 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. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately 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 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

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 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 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 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 condition.

While using this product, patients must be reminded not to exceed the recommended dose, reiterating the overdose warning. Furthermore, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. Lastly, patients should be advised to seek guidance from a doctor or pharmacist if their child 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 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)