Dye Free Pain Reliever

Description

This children's dye-free pain reliever is formulated as an oral suspension containing acetaminophen at a concentration of 160 mg per 5 mL. It serves as both a pain reliever and fever reducer, and is suitable for children aged 2 to 11 years. The product is free from alcohol, aspirin, and ibuprofen, and is flavored with grape.

The packaging includes a tamper-evident feature; 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. This product is distributed by PL Developments, located at 200 Hicks Street, Westbury, NY 11590, and is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension.

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 specific dosing instructions must be followed. Prior to administration, the product should be shaken well. It is essential to utilize only the enclosed dosing cup designed for this product; no other dosing devices should be employed.

Dosing should be determined based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The following dosing chart provides the recommended doses:

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

• 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.

If necessary, doses may be repeated every 4 hours while symptoms persist. However, 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. Care should be taken 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, 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

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the recommended guidelines. Healthcare professionals should advise patients that taking more than five doses within a 24-hour period, which constitutes the maximum daily amount, or using this product in conjunction with other medications containing acetaminophen can lead to serious liver injury.

Patients should also be made aware of the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative that the patient discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

Healthcare professionals should advise patients to stop using the product and seek medical advice 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 for more than three days. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if they do not exhibit any signs or symptoms of overdose. Prompt intervention is essential to mitigate potential health risks.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the medication concurrently with other drugs containing acetaminophen. In cases of overdose, which involves taking more than the recommended dose, patients are advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222), as prompt medical attention is crucial even in the absence of noticeable signs or symptoms.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical help immediately.

Additionally, 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 without delay.

Patients are also advised to stop use and contact a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days, as these may indicate a serious underlying condition.

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 Dye Free 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 weight-based dosing recommended. When possible, dosing should be determined by the child's weight; if weight is not available, age may be used as a guide.

The following dosing chart is provided for reference:

• For patients under 24 lb (under 2 years): Consult a doctor.

• For patients weighing 24-35 lb (2-3 years): Administer 5 mL.

• For patients weighing 36-47 lb (4-5 years): Administer 7.5 mL.

• For patients weighing 48-59 lb (6-8 years): Administer 10 mL.

• For patients weighing 60-71 lb (9-10 years): Administer 12.5 mL.

• For patients weighing 72-95 lb (11 years): Administer 15 mL.

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

Healthcare providers should advise parents or guardians to consult a doctor before use if the child has liver disease or is 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. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of polypharmacy and the presence of comorbid conditions that are common in geriatric patients, which may necessitate dosage adjustments or increased vigilance in monitoring.

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 necessitates careful consideration of potential risks versus benefits.

Given the lack of information on dosage modifications or special precautions, it is advisable for healthcare providers to evaluate the necessity of acetaminophen use in pregnant patients on a case-by-case basis, taking into account the individual patient's health status and the potential impact on fetal outcomes. Women of childbearing potential should be informed of the uncertainties surrounding the use of acetaminophen during pregnancy and encouraged to discuss any concerns with their healthcare provider.

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 due to the potential risk to the infant.

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 individuals with reduced kidney function, as the absence of detailed guidance 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 due to the potential for severe liver damage associated with this product, which contains acetaminophen. 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 mitigate the risk of liver injury.

For pediatric patients with known liver disease, it is advised to consult a healthcare professional prior to use. In the event of an overdose, which may occur if the recommended dosage is exceeded, 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 intervention is essential, even in the absence of noticeable signs or symptoms of liver damage.

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 prompt medical intervention is essential, even in the absence of noticeable symptoms.

Recommended Actions In cases of suspected overdose, immediate medical assistance should be sought. It is advisable to contact a Poison Control Center at 1-800-222-1222 for guidance on the appropriate steps to take.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance and timely response. Healthcare providers should monitor patients closely for any signs of hepatic impairment following an overdose.

Management Procedures Upon recognition of an overdose, healthcare professionals should initiate appropriate management protocols, which may include supportive care and monitoring of liver function. Early intervention can significantly improve outcomes and mitigate the risk of severe complications.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

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.

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. Healthcare providers should also instruct patients 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. 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 configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper handling and adherence to these storage conditions are crucial to ensure 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.

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 Dye Free Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)