Dye Free Pain and Fever

Description

Acetaminophen is an oral suspension formulation containing 160 mg of acetaminophen per 5 mL. This product is dye-free and is indicated for the relief of pain and fever. It is formulated without aspirin, alcohol, or ibuprofen. The suspension has a bubble gum flavor and is provided with a dosage cup for accurate administration. The packaging is tamper-evident; do not use 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 specific populations, and healthcare professionals should be aware that it does not contain complete directions or warnings for adult use. Prior to administration, the product must be shaken well. It is imperative to utilize only the enclosed dosing cup designed for this product; the use of any other dosing device is not recommended.

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 appropriate dosage:

• 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 or aged 2-3 years, the recommended dose is 5 mL.

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

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

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

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

Dosing may be repeated every 4 hours as needed 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 healthcare professional. Careful adherence to these guidelines is essential to ensure patient safety and efficacy of treatment.

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 poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers 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.

Severe skin reactions have been associated with acetaminophen use. 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.

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

General precautions should be observed, particularly in patients with pre-existing conditions. It is advisable to consult a physician before administering this product to children with liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician 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 underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several potential adverse reactions, including serious warnings related to liver damage and severe allergic 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 the product is taken concurrently with other medications containing acetaminophen. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical, even if no signs or symptoms are present. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay in such situations.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance promptly.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a serious condition requiring medical consultation.

It is important to note that this product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Furthermore, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should avoid its use.

Before using this product, patients with liver disease or those taking the blood-thinning medication warfarin should seek advice from a healthcare professional.

Patients are advised to stop using the product and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these could be signs of a serious 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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. 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 and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years are indicated for use. For children under 24 lbs (under 2 years), consultation with a healthcare professional is advised prior to administration.

Dosing is recommended based on weight and age as follows:

• For children weighing 24-35 lbs (2-3 years): 5 mL

• For children weighing 36-47 lbs (4-5 years): 7.5 mL

• For children weighing 48-59 lbs (6-8 years): 10 mL

• For children weighing 60-71 lbs (9-10 years): 12.5 mL

• For children weighing 72-95 lbs (11 years): 15 mL

It is important not to exceed 5 doses in a 24-hour period and not to administer for more than 5 days unless directed by a healthcare provider.

Healthcare professionals should inquire about liver disease before use and should also consult with a doctor or pharmacist if the child is taking the anticoagulant warfarin.

Geriatric Use

There is no specific information regarding the use of DYE FREE PAIN AND FEVER CHILDREN'S - acetaminophen suspension in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Given the lack of data, it is advisable to monitor geriatric patients closely for any adverse effects or changes in response to treatment. Additionally, consideration should be given to potential age-related physiological changes that may affect drug metabolism and clearance.

As there are no established dosage adjustments for this population, clinicians should evaluate the individual needs of elderly patients and adjust the dosage accordingly, while ensuring that safety and efficacy are prioritized.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no stated safety concerns or contraindications related to pregnancy, and no dosage modifications for pregnant individuals are mentioned. Additionally, the insert does not include any special precautions regarding the use of this product in pregnant patients. Healthcare professionals should consider the absence of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

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 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 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 patients with liver disease consult a healthcare professional. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms of overdose are present, as prompt intervention is critical to mitigate potential liver damage.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. It is essential for healthcare professionals to be vigilant regarding the potential consequences of 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 without delay. Quick medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose. Early intervention can significantly impact the management and outcome of the situation.

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 specific postmarketing experience details are provided 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 signs or symptoms are initially present.

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 any uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to ensure that the product is not administered to children who are allergic 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 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 to adhere strictly to the recommended dosage to avoid the risk of overdose. 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 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.

No further 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 and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)