Equaline Childrens Acetaminophen

Description

EQUALINE® is a children's acetaminophen formulation designed for the relief of fever and pain. Each 5 mL dose contains 160 mg of acetaminophen. This oral suspension is suitable for children aged 2 to 11 years and is presented in a bubble gum flavor. The product is free from aspirin, ibuprofen, alcohol, and parabens. It is packaged in a 4 FL OZ (118 mL) bottle, providing fast and effective relief for pediatric patients.

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 as needed while symptoms persist, with a maximum of 5 doses within 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 healthcare professional.

• 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.

Dosing should not exceed the specified amounts, and healthcare professionals should advise caregivers to consult them if there are any uncertainties regarding the appropriate dose. It is critical to use only the enclosed dosing cup designed for this product and to avoid using any other dosing devices.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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 history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

• Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

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.

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

Healthcare professionals should inquire about the presence of liver disease before recommending this product for use in children. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as rapid intervention can be critical.

Patients should be advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be aware that acetaminophen may also lead to 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 and seek immediate medical assistance.

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.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients with a known allergy to this product or any of its ingredients should also refrain from use. Additionally, it is advisable for patients with liver disease to consult a doctor prior to using this product. Caution is warranted for patients taking the anticoagulant warfarin, and they should seek guidance from a healthcare provider or pharmacist before use.

While using this product, patients must adhere to the recommended dosage to avoid overdose. They should 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 redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is crucial, and patients should contact a Poison Control Center without delay, even if no symptoms are apparent. It is essential to keep this product out of reach of children to prevent accidental ingestion.

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 other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may be heightened, leading to serious hepatic complications. 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 Equaline Childrens Acetaminophen (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 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 to 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 not to exceed 5 doses within a 24-hour period. Prior to administration, healthcare professionals should inquire if the child has liver disease or is taking the anticoagulant warfarin, as these conditions may necessitate caution.

Additionally, this product should not be used in children with a known allergy to it or any of its ingredients. Parents and caregivers should be advised to discontinue use and consult a doctor if the child's 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.

Geriatric Use

Elderly patients may not receive comprehensive guidance or warnings regarding the use of this product, as the labeling does not include specific directions or complete warnings for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for increased sensitivity to medications and the likelihood of comorbidities that may affect treatment outcomes.

It is essential for healthcare providers to monitor elderly patients closely for any adverse effects and to consider individual patient factors when determining the appropriateness of this product. Due to the lack of specific dosage adjustments or safety data for this population, careful clinical judgment is advised.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending acetaminophen to women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its effects on fetal outcomes.

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 should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols to ensure safe and effective use of the medication.

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. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient 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 medical intervention is essential, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are crucial in managing overdose situations effectively.

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

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

It is essential to instruct patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist.

Patients should be cautioned against using this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, healthcare providers should emphasize the need to discontinue use and consult a doctor if the child's 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.

When using this product, patients must be reminded not to exceed the recommended dosage, in line with the overdose warning. Healthcare providers should also 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 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

The medication is administered orally. Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

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

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