Up and up Juniors Acetaminophen

Description

NDC 11673-160-32. This product contains acetaminophen as the active ingredient, formulated as chewable tablets with a strength of 160 mg. It serves as a pain reliever and fever reducer, specifically designed for children aged 6 to 11 years. The tablets are grape-flavored, aspirin-free, and ibuprofen-free. Each package contains 24 chewable tablets. The product is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is not manufactured or distributed by McNeil Consumer Healthcare, the owner of the registered trademark Junior Strength Tylenol® Meltaways®. Distributed by Target Corporation, Minneapolis, MN 55403. © 2014 Target Brands, Inc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, and headache. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in specific populations, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

For patients weighing under 48 pounds or children under 6 years of age, it is advised to consult a physician before administration. For those weighing between 48 and 59 pounds, the recommended dose is 2 tablets. Patients weighing 60 to 71 pounds should receive 2 ½ tablets, while those weighing 72 to 95 pounds should be administered 3 tablets. For individuals weighing 96 pounds or more, the dosage is 4 tablets.

In terms of age-based dosing, children aged 6 to 8 years should receive 2 tablets, while those aged 9 to 10 years should be given 2 ½ tablets. For children aged 11 years, the recommended dose is 3 tablets, and for those aged 12 years and older, 4 tablets is appropriate.

The tablets should be dissolved in the mouth or chewed thoroughly before swallowing. If symptoms persist, the dose may be repeated every 4 hours as needed; however, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, this product should not be administered for more than 5 consecutive days unless directed by a healthcare professional.

Healthcare providers should ensure that patients do not exceed the recommended dosage to avoid the risk of 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 known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

Additionally, it is imperative not to exceed the recommended dosage, as doing so may result in overdose and associated complications.

Warnings and Precautions

Severe liver damage may occur in children 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 consult a physician prior to administration if the child has a history of liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is currently prescribed warfarin, a blood-thinning medication, as interactions may pose significant risks.

In the event of an overdose, immediate medical assistance is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare providers should instruct caregivers to discontinue use and consult a physician if any of the following occur: worsening pain that persists beyond five days, a fever that worsens or lasts more than 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.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen.

It is crucial to avoid using this product in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. Patients should consult a doctor or pharmacist if there is uncertainty regarding the presence of acetaminophen in other medications. Additionally, this product should not be used by patients who have a known allergy to acetaminophen or any of the inactive ingredients included in the formulation.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the anticoagulant warfarin should consult a healthcare professional prior to use, as interactions may occur.

While using this product, it is imperative not to exceed the recommended dosage. Patients should discontinue use and consult a doctor 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, as these may indicate a serious underlying condition.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as prompt medical attention is critical.

To ensure safety, this product should be kept out of reach of children.

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 any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. 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 Up and up Juniors Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age who weigh less than 48 pounds should be advised to consult a doctor before use. For children aged 6 to 8 years weighing between 48 and 59 pounds, the recommended dosage is 2 tablets. Children aged 9 to 10 years who weigh between 60 and 71 pounds should receive 2 1/2 tablets, while those aged 11 years and weighing between 72 and 95 pounds should take 3 tablets. For children aged 12 years and older, weighing 96 pounds and above, the dosage is 4 tablets.

It is critical not to exceed the recommended dosage, with a maximum of 5 doses allowed within a 24-hour period. Additionally, the medication should not be administered for more than 5 consecutive days unless directed by a healthcare professional.

Healthcare providers should be consulted prior to use if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin. Parents and caregivers must ensure that the medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance tailored to this population. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to monitor elderly patients closely for any adverse effects or complications that may arise from the use of this product, given the lack of established safety and efficacy data in this demographic. Dose adjustments may be necessary based on individual patient assessments, particularly considering the potential for altered pharmacokinetics and increased sensitivity to medications in older adults.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Additionally, no information is provided about safety concerns, dosage modifications, or special precautions related to its use in pregnant patients. Furthermore, there are no contraindications in pregnancy mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of 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 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 be closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that a healthcare professional be consulted if the patient has a history of liver disease. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical attention is critical, even in the absence of noticeable signs or symptoms of liver damage.

Overdosage

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that immediate medical intervention is essential, even in the absence of noticeable symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance promptly. Healthcare providers should advise patients or caregivers to contact a Poison Control Center without delay at 1-800-222-1222. Quick action can be critical in mitigating potential harm.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance and proactive management. Healthcare professionals should monitor for any signs of liver impairment and be prepared to initiate appropriate treatment protocols.

In summary, the management of overdose situations requires immediate attention and a thorough understanding of the potential risks involved. Prompt communication with medical professionals and poison control resources is vital to ensure patient safety and effective intervention.

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.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage to avoid the risk of overdose, which may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, emphasizing that prompt medical attention is crucial even if no signs or symptoms are present.

Providers should also remind patients not to exceed the recommended dose, reiterating the overdose warning. It is essential to encourage patients to consult with a healthcare professional before use if their child has a history of liver disease. Additionally, patients should be advised to speak with their doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, as this may require special consideration.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20º-25ºC (68º-77ºF) while ensuring that it is kept away from high humidity conditions. For proper inventory management, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients are instructed to discontinue use and seek medical advice 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. 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.

Drug Information (PDF)

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

View product document (PDF)