Dye Free Pain and Fever

Description

Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever, containing 160 mg of acetaminophen per 5 mL. This product is designed for use in children aged 2 to 11 years and is available in a grape flavor. The formulation is free from dyes, aspirin, alcohol, and ibuprofen. A dosage cup is included for accurate measurement. The product is 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. It is distributed by Walgreen Co., located in Deerfield, IL 60015. For more information, visit walgreens.com.

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.

Prior to administration, the product must be shaken well. It is essential to use only the enclosed dosing cup specifically designed for this product; no other dosing devices should be utilized to ensure accurate dosing.

The recommended dosing intervals are as follows: if necessary, the dose 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 physician.

The following dosage chart provides guidance based on weight and age:

• For patients weighing less than 24 lb or under 2 years of age, consultation with a doctor is advised.

• 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 also be adjusted as directed by a healthcare professional. It is imperative to adhere to the maximum dosage limits and duration of use to avoid potential 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 formulation, 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 with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 5 doses within a 24-hour period. Caution is particularly warranted when this product is used concurrently with other medications containing acetaminophen, as this can significantly increase the risk of liver injury.

Patients should be informed 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, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare provider without delay.

Healthcare professionals should instruct 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 5 days, or a fever that worsens or persists beyond 3 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 directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are immediately apparent. 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 product in conjunction with other medications containing acetaminophen. Patients should be aware that acetaminophen can lead to severe skin reactions, 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.

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 promptly. The product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Parents should ensure that their child is not allergic to acetaminophen or any inactive ingredients in the product prior to administration.

Before using this product, it is advisable for parents to consult a doctor if their child has liver disease or is taking the blood-thinning medication warfarin. While using this product, patients must adhere to the recommended dosage to avoid overdose, which can result in liver damage. Patients should discontinue use and seek medical advice 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, as these may indicate a serious condition.

In cases of overdose, immediate medical attention is crucial, even if no signs or symptoms are present. Patients are encouraged to contact a Poison Control Center (1-800-222-1222) without delay.

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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

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 may receive this medication according to a specific dosing chart based on weight and age. For children under 24 lb and under 2 years of age, consultation with a doctor is advised prior to administration. The recommended dosages for children within the specified age and 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 inquire about any existing liver disease in pediatric patients before use. Additionally, consultation with a doctor or pharmacist is recommended if the child is concurrently taking the anticoagulant warfarin. As with all medications, this product should be kept out of reach of children.

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, healthcare providers should evaluate the individual needs of elderly patients and adjust the treatment regimen accordingly, ensuring that safety and efficacy are prioritized.

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 this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen 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 adequately assessed.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 must avoid concomitant use with other medications containing acetaminophen to mitigate the risk of liver injury.

For pediatric patients with liver disease, it is advised to consult a healthcare professional prior to use. In the event of an overdose, which is defined as 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 intervention is essential, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals act swiftly to mitigate the risks associated with such an occurrence.

Immediate medical assistance is crucial. In cases of suspected overdose, healthcare providers should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

It is important to note that quick medical attention is essential, even in the absence of noticeable signs or symptoms. Early intervention can be critical in preventing serious complications related to liver function.

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

Postmarketing experience has revealed that acetaminophen may cause severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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. 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.

Healthcare providers should remind patients to adhere strictly to the recommended dosage and to seek medical advice before use if their child has liver disease. Additionally, patients should be advised to consult a doctor or pharmacist if their child 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 proper identification, the lot number and expiration date are located on the bottom panel of the packaging. Care should be taken to ensure that these details are accessible for reference.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with the option to repeat doses every 4 hours as needed while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period or to use the medication for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Additionally, patients should be advised to discontinue use and seek medical attention if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

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.

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