Rugby Infants Acetaminophen

Description

Rugby® is an oral suspension formulation containing Infants’ Acetaminophen at a concentration of 160 mg per 5 mL. This product is designed as a pain reliever and fever reducer specifically for children aged 2 to 3 years. The formulation is free from parabens, alcohol, aspirin, and ibuprofen, and is dye-free, featuring a cherry flavor for palatability. Each bottle contains 2 fluid ounces (59 mL) of the suspension and is intended for use with the enclosed syringe, which is part of a pediatrician-preferred dosing system.

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 dosing chart for appropriate administration. It is essential to shake the product well before use. The correct dose should be determined based on the child's weight; if weight is not available, age may be used as a guide.

To prepare the dose, healthcare professionals should follow these steps:

1. Push air out of the enclosed syringe and insert the syringe tip into the bottle opening.

2. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

3. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period.

For dosing specifics, refer to the following chart:

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

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

It is crucial to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for this product should be used for dosing; no other dosing devices are acceptable. Healthcare professionals should ensure that the product is not administered in excess of the recommended dosage to avoid overdose.

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 adverse reactions.

Additionally, while using this product, it is essential not to exceed the recommended dosage to avoid the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of hepatotoxicity.

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 two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should inquire about any existing liver disease in pediatric patients prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as potential interactions may necessitate closer monitoring.

In the event of an overdose, immediate medical attention is crucial. 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.

Patients should be advised to discontinue use and consult a healthcare provider 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 requiring 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 advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate cessation of use and prompt medical attention are necessary.

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 without delay.

Additional precautions include advising patients to discontinue use and seek medical advice if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

It is recommended that patients consult a healthcare provider prior to use if they have a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional or pharmacist before using this product.

In the event of an overdose, it is critical to obtain medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical intervention is essential, 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 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 Infants Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 3 years may use Rugby Laboratories Infants’ Acetaminophen, with a recommended dose of 5 mL for those weighing between 24-35 pounds. For children under 2 years of age, a healthcare professional should be consulted before administration.

Safety precautions are essential when administering this medication. Parents or caregivers should seek medical advice if the child has liver disease or is taking warfarin, a blood-thinning medication. The maximum dosage should not exceed 5 doses within a 24-hour period. If the child has a history of allergic reactions to this product or any of its ingredients, use should be avoided. Additionally, if pain worsens or persists beyond 5 days, fever lasts more than 3 days, new symptoms arise, or if redness or swelling occurs, a healthcare provider should be consulted.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial even if no symptoms are evident.

Administration should be performed using the enclosed syringe specifically designed for this product; other dosing devices are not recommended. The correct dose should be determined based on the provided dosing chart, prioritizing weight when possible. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek, and doses may be repeated every 4 hours as needed, without exceeding 5 doses in a 24-hour period.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the individual health status and potential comorbidities of elderly patients, as these factors may influence the safety and efficacy of the treatment. Close monitoring is recommended to ensure appropriate management and to mitigate any risks associated with the use of this product in the geriatric population.

Pregnancy

There are no specific statements regarding the use of Rugby Infants’ Acetaminophen during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that women of childbearing potential discuss the use of this medication with their healthcare provider to weigh potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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.

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 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 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 complications. Therefore, monitoring and evaluation should be conducted as soon as possible to assess the patient's condition and determine the appropriate course of action.

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. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks. It is important for healthcare providers to remind patients of the overdose warning associated with the medication.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, patients should be advised to speak with their doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This interaction could have significant implications for the child's health and treatment plan.

Storage and Handling

The product is supplied in a configuration that includes a specific syringe designed exclusively for its use. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its efficacy and safety.

Healthcare professionals should inspect the product prior to use; it must not be utilized if the printed neckband is broken or missing. To maintain child resistance, the cap should be replaced tightly after each use. It is imperative to use only the enclosed syringe for dosing, as other dosing devices may compromise the product's integrity and effectiveness.

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 exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Patients should discontinue use and seek medical advice if pain worsens or lasts more than 5 days, if fever intensifies or persists beyond 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial even in the absence of noticeable symptoms.

Drug Information (PDF)

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

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