Up and up Acetaminophen

Description

Infants’ Acetaminophen is an oral suspension formulated to provide relief from fever and pain. Each 5 mL dose contains 160 mg of acetaminophen. The product is dye-free and does not contain high fructose corn syrup, alcohol, ibuprofen, or aspirin. It is flavored with grape and is intended for use in infants aged 2 to 3 years. The suspension is packaged in a 2 FL OZ (59 mL) bottle and includes a syringe for accurate dosing.

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 use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the child's weight or age.

Prior to administration, the product must be shaken well. The enclosed syringe, specifically designed for use with this product, should be utilized for accurate dosing. To prepare the dose, push air out of the syringe and insert the syringe tip into the bottle opening. The bottle should then be flipped upside down. Pull the yellow part of the syringe to the first dose line, then push the product back into the bottle. Next, 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 children weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor for the appropriate dose. For children weighing between 24 and 35 pounds, or aged 2 to 3 years, the recommended dose is 5 mL.

It is crucial to replace the cap tightly after use to maintain child resistance. Healthcare professionals should ensure that no more than the directed amount is administered, in accordance with 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.

This product should not be administered to children who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse effects.

Additionally, exceeding the recommended dosage is contraindicated, as it poses a significant 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 also contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

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 without delay.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, a prompt consultation with a healthcare provider is recommended. This is crucial to rule out any serious underlying conditions.

Healthcare professionals should instruct caregivers to stop use and consult a doctor 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 medical condition.

In the event of an overdose, immediate medical attention is essential. Caregivers should contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as rapid intervention can be critical.

Before administering this product, it is advisable for caregivers to consult a healthcare professional if the child has a history of liver disease. Additionally, if the child is currently taking the anticoagulant warfarin, it is important to seek guidance from a doctor or pharmacist prior to use to avoid potential interactions.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if more than 5 doses are taken within a 24-hour period or if it is used concurrently with other medications containing acetaminophen. Patients should be advised to avoid exceeding the recommended dosage to mitigate this risk.

Allergic reactions may manifest as severe skin reactions, which can include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

It is contraindicated to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, patients with a history of allergic reactions to this product or any of its ingredients should not use it.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 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. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is essential.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in any other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Up and up 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, particularly if they weigh less than 24 pounds. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL, or as directed by a healthcare professional. It is advised to use weight for dosing whenever possible; otherwise, age may be used as a guide.

Healthcare professionals should be aware of specific warnings: parents or guardians should consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin.

For administration, it is essential to use the enclosed syringe specifically designed for this product and to avoid using any other dosing device.

Storage conditions should be maintained at 20-25°C (68-77°F). This product does not include 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 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

There is no specific information available regarding the use of UP AND UP ACETAMINOPHEN INFANTS during pregnancy. Consequently, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider before using this medication.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

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 patients 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 to determine the appropriateness of treatment and any necessary dosage adjustments. Monitoring of liver function may be required 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 crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications arising from the overdose.

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

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 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 while symptoms persist, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial even if no symptoms are apparent. It is important to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients should discontinue use and consult a healthcare professional if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if new symptoms or signs of redness or swelling occur, as these may indicate a serious condition.

Drug Information (PDF)

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

View product document (PDF)