Pain Relief Fever Reducer

Description

Ellywell is an oral suspension formulated as a children's pain reliever and fever reducer, containing acetaminophen at a concentration of 160 mg per 5 mL. The product is presented in an orange flavor and is sweetened with stevia. It is free from dyes, aspirin, ibuprofen, and alcohol, making it suitable for children aged 2 to 11 years. This formulation is comparable to the active ingredient in Children's Tylenol® Oral Suspension. It is important to note that this product is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension. The packaging includes a tamper-evident feature; the product 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. Ellywell is distributed by Ellywell, Naperville, IL.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, flu, 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 following dosage chart provides guidance based on weight and age:

• For patients weighing less than 24 lb and under 2 years of age, the dose is to be determined by a doctor.

• For patients weighing 24-35 lb and aged 2-3 years, the dose is 5 mL.

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the recommended dosages and should consult a physician for any uncertainties or if symptoms persist.

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 dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

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.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if a child exceeds five doses within a 24-hour period, which is the maximum recommended daily amount, or if acetaminophen is taken concurrently with other medications containing acetaminophen.

Healthcare professionals should be vigilant regarding 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, it is essential to consult a physician promptly.

Patients should be advised to stop use and seek medical advice 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as prompt intervention is critical.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product, particularly those containing acetaminophen.

Severe skin reactions have been reported, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage if the maximum daily dosage of acetaminophen is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a healthcare professional prior to use.

In clinical observations, it is advised that if a sore throat is severe, persists for more than two days, or is accompanied by symptoms such as fever, headache, rash, nausea, or vomiting, patients should seek medical attention promptly.

Patients are cautioned against using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended.

During the use of this product, patients should adhere strictly to the recommended dosage to avoid the risk of overdose, which may lead to liver damage. In cases of overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised, as prompt medical attention is crucial even in the absence of noticeable symptoms.

Patients should 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, as these may indicate 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. The risk of acetaminophen overdose and associated hepatotoxicity may be heightened. 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 Fever Reducer (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may use this medication with specific dosing guidelines based on weight and age. For children weighing under 24 lb and under 2 years of age, consultation with a doctor is advised prior to use. The recommended dosages for children aged 2-11 years 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 use should not exceed 5 days unless directed by a healthcare professional.

Caution is advised for pediatric patients with liver disease; consultation with a doctor is recommended before use. Additionally, if the child is taking the blood-thinning medication warfarin, a doctor or pharmacist should be consulted prior to use.

Parents and caregivers 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, use should be discontinued immediately, and medical assistance should be sought.

Severe liver damage may occur if the child exceeds 5 doses in 24 hours or if used concurrently with other medications containing acetaminophen.

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

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is essential to evaluate the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

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. The absence of safety concerns, dosage modifications, or special precautions in the labeling indicates a lack of comprehensive clinical or animal study data to inform risk assessment. Therefore, 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 evaluated.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes acetaminophen.

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 absence of 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 consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the patient exceeds five doses within a 24-hour period, as this represents the maximum daily dosage.

In cases of overdose, which may occur if the recommended dosage is surpassed, there is a significant risk of liver damage. Patients are advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms of overdose are apparent. Prompt medical intervention is essential to mitigate potential liver injury.

Overdosage

Taking more than the recommended dose of the medication may lead to serious 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 immediate 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

Postmarketing experience has identified several important safety considerations associated with the use of acetaminophen. Reports indicate that severe skin reactions may occur, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek immediate medical assistance.

Additionally, there is a warning regarding the potential for severe liver damage, particularly if the maximum daily dosage of five doses within 24 hours is exceeded, or if acetaminophen is taken concurrently with other medications containing the same active ingredient.

Furthermore, cases of overdose have been reported, which may lead to liver damage. In instances of overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately, as prompt medical attention is essential, even in the absence of noticeable signs or symptoms.

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 apparent.

Patients should be informed not to use this product in conjunction with any other medications containing 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 within the formulation.

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 underlying condition.

While using this product, patients must be reminded not to exceed the recommended dosage, reiterating the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. Furthermore, it is advisable for patients 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 various package configurations, with specific NDC numbers available upon request. 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. 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 a recommended dosing frequency of 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 Pain Relief Fever Reducer, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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