Equate Childrens Pain and Fever

Description

equate™ is an oral suspension formulation designed for the relief of pain and fever in children aged 2 to 11 years. The active ingredient, acetaminophen, is present at a concentration of 160 mg per 5 mL. This product is alcohol-free, aspirin-free, and ibuprofen-free, and it does not contain high fructose corn syrup or dyes. The suspension is cherry flavored and is packaged in an 8 FL OZ (237 mL) bottle, which includes a dosage cup for accurate measurement.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The appropriate dose should be determined using the provided dosage chart, which considers the child's weight and age. If possible, weight should be used for dosing; otherwise, age may be utilized.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for this product. The dose may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period.

The dosage chart is as follows:

• For children under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing 24-35 lb (2-3 years), the dose is 5 mL.

• For children weighing 36-47 lb (4-5 years), the dose is 7.5 mL.

• For children weighing 48-59 lb (6-8 years), the dose is 10 mL.

• For children weighing 60-71 lb (9-10 years), the dose is 12.5 mL.

• For children weighing 72-95 lb (11 years), the dose is 15 mL.

It is crucial to adhere strictly to these dosing instructions and to avoid administering more than the recommended amount, as indicated in the overdose warning.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

Additionally, this product should not be used in patients who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

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 5 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. Should any of these symptoms manifest, it is imperative to 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 fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

General precautions should be observed prior to administration. Caregivers should be advised to consult a physician if the child has a history of liver disease. Furthermore, it is recommended to seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is critical. Caregivers should be instructed to 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 also counsel caregivers to discontinue use and consult a physician if the child experiences worsening pain lasting more than 5 days, fever that worsens or persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, 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.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

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

In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential, even if no signs or symptoms are 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 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 Equate Childrens 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 with specific dosing guidelines based on weight and age. For children under 24 lb, consultation with a doctor is advised. The recommended dosages for children by weight and age 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

When administering the medication, weight should be used for dosing whenever possible; if weight is not available, age may be used instead. Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period.

Healthcare professionals should be aware of specific warnings for pediatric use. Consultation with a doctor is recommended if the child has liver disease or is taking the anticoagulant warfarin. It is crucial to adhere to the recommended dosing guidelines and keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is necessary.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when considering this product for geriatric patients, as the lack of comprehensive information may impact safety and efficacy. It is advisable to closely monitor elderly patients for any adverse effects and to consider alternative therapies that provide clearer dosing and safety information.

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. 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 healthcare providers to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to establish a clearer understanding of the implications of acetaminophen use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and 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 this medication.

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. 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 use, particularly if they have a history of liver disease. It is essential to evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals adhere to the recommended dosing guidelines, as exceeding the advised dosage can lead to serious health risks.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is crucial, even if the patient does not exhibit any immediate signs or symptoms of overdose.

It is essential to monitor the patient closely and provide supportive care as necessary while awaiting further medical guidance.

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

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 to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that 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 that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be encouraged to speak with a doctor or pharmacist prior to use 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. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients should be instructed to discontinue use and seek immediate medical attention if a skin reaction occurs. Additionally, if a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. Patients should also stop use and contact a healthcare provider if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

This file contains official product information for Equate Childrens Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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