Rugby Childrens Acetaminophen

Description

Rugby® is an oral suspension formulation containing 160 mg of acetaminophen per 5 mL, designed for the relief of pain and reduction of fever in children. This product is comparable to the active ingredient in Children’s Tylenol® Oral Suspension. It is ibuprofen-free, alcohol-free, and aspirin-free, making it suitable for a wide range of pediatric patients. The suspension is flavored with grape and is intended for use in children aged 2 to 11 years. Each bottle contains 4 FL OZ (118 mL) of the product.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should advise caregivers to adhere strictly to the dosing guidelines provided, ensuring that no more than the recommended dose is administered to avoid the risk of overdose.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference.

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

Dosage Chart:

• For children weighing under 24 lb (under 2 years): Dose is to be determined by a doctor.

• For children weighing 24-35 lb (2-3 years): Administer 5 mL.

• For children weighing 36-47 lb (4-5 years): Administer 7.5 mL.

• For children weighing 48-59 lb (6-8 years): Administer 10 mL.

• For children weighing 60-71 lb (9-10 years): Administer 12.5 mL.

• For children weighing 72-95 lb (11 years): Administer 15 mL.

Dosing should always be conducted using the enclosed dosing cup, and no other dosing device should be utilized.

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 a medication, 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 dose is contraindicated due to the potential for overdose.

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.

Acetaminophen may also trigger severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken when administering this product. It is advisable to consult a physician prior to use if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In cases of suspected overdose, immediate medical attention is critical. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the product 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. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A warning is also issued regarding sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients are advised to stop use and seek medical advice if pain worsens or lasts longer than 5 days, if fever worsens or persists for more than 3 days, if new symptoms arise, or if redness or swelling is observed, 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. 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 Rugby Childrens Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 11 years, dosing is based on weight, with specific volumes recommended for different weight ranges: 5 mL for those weighing 24-35 lb (2-3 years), 7.5 mL for 36-47 lb (4-5 years), 10 mL for 48-59 lb (6-8 years), 12.5 mL for 60-71 lb (9-10 years), and 15 mL for those weighing 72-95 lb (11 years).

It is important to adhere strictly to the recommended dosing and to use the enclosed dosing cup designed for this product; other dosing devices should not be used. Caregivers should keep the product out of reach of children and be aware of the overdose warning, which advises seeking immediate medical help or contacting a Poison Control Center (1-800-222-1222) in case of overdose, even if no symptoms are present.

Before administering this product, caregivers should consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. If pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms arise, or redness or swelling occurs, caregivers should discontinue use and consult a doctor. This product does not contain directions or complete warnings for adult use.

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 advisable to assess 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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 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 intervention is essential, as quick medical attention can significantly impact the outcome, even if the individual does not exhibit any noticeable signs or symptoms of overdose.

Healthcare professionals are advised to remain vigilant and proactive in managing potential overdose situations. The absence of symptoms does not negate the need for evaluation and treatment, as some effects may not be immediately apparent. Therefore, it is crucial to ensure that appropriate medical care is initiated without delay.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 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 dose, 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 potential tampering or compromise of the product's 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 advise 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 present.

Drug Information (PDF)

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

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