Equate 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 is also free from parabens. The suspension is grape-flavored to enhance palatability for pediatric patients. Each bottle contains 4 fluid ounces (118 mL) of the product, and a dosage cup is included 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

This product is intended for pediatric use only, and healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the child's weight or age. It is essential to shake the product well before each use.

To administer the dose, remove the child protective cap and squeeze the appropriate amount into the enclosed dosing cup. The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

Dosage Chart:

• For children weighing under 24 lb or under 2 years of age, the dose is to be determined by a doctor.

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

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

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

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

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

It is critical not to exceed the recommended dosage, and healthcare professionals should advise caregivers to consult a doctor if there are any uncertainties regarding dosing. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate for this product.

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. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• This product should not be administered to children who have a history of allergic reactions to this product or any of its components.

• Exceeding the recommended dosage is contraindicated; refer to the overdose warning for further details.

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 exceeding five doses within a 24-hour period, which constitutes the maximum daily amount, or concomitant use with other medications containing acetaminophen can lead to serious hepatic injury.

Acetaminophen may also provoke severe skin reactions, which can 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 without delay.

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 promptly.

Healthcare providers should counsel patients to stop using the product and seek medical advice if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These signs 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 symptoms are apparent, as prompt intervention is essential.

Side Effects

Severe liver damage may occur in patients if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if this product is used 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.

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

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or persists beyond 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have liver disease or if they are taking the blood-thinning medication warfarin. In the case of an 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 critical even in the absence of noticeable signs or symptoms.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to anticoagulation. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive varying doses of this product based on their weight. The recommended dosages are as follows: for children weighing under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (2-3 years), the dose is 5 mL; for 36-47 lb (4-5 years), the dose is 7.5 mL; for 48-59 lb (6-8 years), the dose is 10 mL; for 60-71 lb (9-10 years), the dose is 12.5 mL; and for those weighing 72-95 lb (11 years), the dose is 15 mL.

Healthcare professionals should be aware of the liver warning associated with this product, as it contains acetaminophen. Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Prior to use, it is important to consult a doctor if the child has liver disease or has ever had an allergic reaction to this product or any of its ingredients.

Parents and caregivers should be instructed to stop use and seek medical advice if the child's pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if there is any redness or swelling. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt medical attention is critical even if no signs or symptoms are present.

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 for this population. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as they may have different responses compared to younger adults.

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

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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation is necessary to ensure the safe and effective use of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals are advised to remain vigilant and act swiftly, as timely medical attention can significantly influence the outcome of an overdose situation. It is crucial to monitor the patient closely for any emerging symptoms, even if they initially appear asymptomatic.

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 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.

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 for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dosage, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised 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 informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, 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 are advised to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. In the event of an overdose, immediate medical assistance should be sought, and patients should contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even in the absence of symptoms.

Drug Information (PDF)

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

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