Pain Relief

Description

Acetaminophen is provided in an oral suspension form, delivering 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer, specifically designed for children aged 2 to 11 years. The product is alcohol-free, aspirin-free, and ibuprofen-free, featuring a bubble gum flavor to enhance palatability.

This product is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension. It is produced by PL Developments, located at 11865 S. Alameda St, Lynwood, CA 90262.

The product includes a tamper-evident feature; it should not be used if the printed safety seal around the dosage cup 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 and 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.

The dosage chart is as follows:

• For patients weighing less than 24 lb and 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.

Dosing should be adjusted as necessary based on the patient's specific needs and in accordance with a physician's guidance. It is imperative to adhere to the maximum dosage recommendations and to consult a healthcare professional if there are any questions or concerns regarding the use of this product.

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 formulation, as this may lead to severe allergic reactions.

Additionally, it is essential to adhere to the recommended dosage to avoid the risk of overdose.

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 also contain acetaminophen.

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.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should instruct patients to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than 5 days, or if fever intensifies or persists beyond 3 days. These symptoms may indicate a serious underlying condition.

An overdose of acetaminophen can lead to significant liver damage. In the event of an overdose, immediate medical attention is crucial, even if no symptoms are present. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Prior to administration, it is essential to consult a healthcare provider if the child has a history of liver disease. Additionally, if the child is taking the anticoagulant warfarin, it is recommended to seek advice from a doctor or pharmacist before use.

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 any 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, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

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 beyond 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of therapy. Adjustments to the dosage of either medication may be required based on clinical judgment and laboratory results.

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. For children weighing under 24 lb, consultation with a healthcare provider is advised prior to use. The recommended dosages for children within the specified age range 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 avoid use for more than 5 consecutive days unless directed by a healthcare professional.

Caution is advised when administering this medication to pediatric patients with liver disease, and consultation with a healthcare provider or pharmacist is recommended if the child 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.

Pregnancy

Acetaminophen is not associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate that the product is contraindicated in pregnant patients, nor does it outline any known risks to the fetus associated with its use during this period. Additionally, there are no recommendations for dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the overall clinical context when advising pregnant patients regarding the use of acetaminophen.

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 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.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is essential 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. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential, even in the absence of noticeable symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance promptly. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance and prompt evaluation by medical professionals.

Management Procedures Upon identification of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. Early intervention can significantly improve outcomes for affected individuals.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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. 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 underlying condition.

Healthcare providers should remind patients to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, 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 various package configurations, with specific NDC numbers available 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. 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 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)