Premier Value Childrens Acetaminophen Melts

Description

NDC 68016-196-00. This product contains acetaminophen as the active ingredient, serving as a pain reliever and fever reducer. It is formulated for children aged 2 to 6 years and is available in a grape flavor. Each dosage form consists of 80 mg acetaminophen, with a total count of 30 units per package. The formulation is free from aspirin and ibuprofen. The product features a tamper-evident safety seal; it should not be used if the printed safety seal under the cap is broken or missing. This product is marketed under the Premier Value brand and is not manufactured or distributed by McNeil Consumer Healthcare, the owner of the registered trademark Children's Tylenol® Meltaways®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, flu, sore throat, and toothache. 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 children and should not be administered to adults without specific directions or warnings. Healthcare professionals are advised to adhere strictly to the dosing guidelines provided to avoid the risk of overdose.

For optimal dosing, it is recommended to determine the appropriate dose based on the child's weight. If weight is not available, age may be used as a secondary reference. The following dosing chart should be utilized:

• For children weighing under 24 lb (under 2 years), consult a physician before administration.

• For children weighing 24-35 lb (ages 2-3 years), administer 2 tablets.

• For children weighing 36-47 lb (ages 4-5 years), administer 3 tablets.

• For children weighing 48-59 lb (ages 6-8 years), administer 4 tablets.

• For children weighing 60-71 lb (ages 9-10 years), administer 5 tablets.

• For children weighing 72-95 lb (ages 11 years), administer 6 tablets.

The tablets should be chewed thoroughly before swallowing, as they are designed to soften in the mouth to facilitate easier chewing. Dosing may be repeated every 4 hours as needed while symptoms persist, but 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.

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.

• Exceeding the recommended dosage is contraindicated, as it may result in serious adverse effects.

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. Healthcare professionals should advise parents and caregivers to monitor the total intake of acetaminophen from all sources to prevent potential toxicity.

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, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Before administering this product, healthcare providers should inquire about any existing liver disease in the child. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as interactions may occur.

In the event of an overdose, immediate medical assistance should be sought. Parents and caregivers are advised to contact a Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening pain that lasts more than 5 days, a fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious condition that necessitates further investigation and intervention.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if the product is taken concurrently with other medications containing acetaminophen. Patients are advised to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a healthcare provider if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

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

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if pain worsens or lasts more than 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, which may lead to liver damage, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Drug Interactions

The concomitant use of this product with warfarin, an anticoagulant, may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, this product should not be used in conjunction with any medications that contain acetaminophen, whether prescription or over-the-counter. Patients should be encouraged to consult with a healthcare professional if there is uncertainty regarding the presence of acetaminophen in their medications.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value Childrens Acetaminophen Melts (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients require careful consideration when administering this medication. The recommended dosages based on weight and age are as follows: for children under 24 pounds or under 2 years of age, consultation with a doctor is advised. For those weighing 24-35 pounds (2-3 years), the dose is 2 tablets; for 36-47 pounds (4-5 years), 3 tablets; for 48-59 pounds (6-8 years), 4 tablets; for 60-71 pounds (9-10 years), 5 tablets; and for those weighing 72-95 pounds (11 years), 6 tablets.

Healthcare professionals should be aware of specific warnings associated with pediatric use. Parents or caregivers should be advised to consult a doctor before use if the child has liver disease. It is crucial not to exceed the recommended dosage, as an overdose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and the Poison Control Center can be contacted at 1-800-222-1222. Quick medical attention is essential for both children and adults, even if no symptoms are apparent.

When administering the medication, it is important to follow the dosing directions carefully. The appropriate dose should be determined using the provided chart, prioritizing weight over age when possible. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period. Additionally, the medication should not be given for more than 5 consecutive days unless directed by a healthcare professional.

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 evaluate 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 product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen during pregnancy. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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 important to note that exceeding the recommended dosage may lead to liver damage. In the event of an overdose, immediate medical assistance is essential. Patients and caregivers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

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 for both adults and children, regardless of the presence of symptoms.

Recommended Actions In cases of suspected overdose, it is imperative to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center immediately at 1-800-222-1222. Prompt 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. Healthcare professionals should educate patients on the necessity of monitoring for any unusual signs or symptoms following an overdose.

Management Procedures Upon receiving a patient with a suspected overdose, healthcare professionals should initiate appropriate management protocols. This may include supportive care and monitoring of liver function, as well as considering the administration of antidotes or other interventions as clinically indicated. Early recognition and treatment are vital to improving outcomes in cases of 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, 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 known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. 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.

Healthcare providers should stress the importance of adhering to the recommended dosage and advise patients to consult a doctor before use if their child has liver disease. Furthermore, patients should be encouraged 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, which can be found on the packaging. It is essential to store the product at a controlled room temperature of 20-25ºC (68-77ºF). Care should be taken to avoid high humidity conditions and to protect the product from light exposure.

For reference, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

The product is administered orally. Clinicians should counsel patients to keep the medication out of reach of children and to be aware of the overdose warning, as exceeding the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and the Poison Control Center can be contacted at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if no symptoms are apparent.

Patients should be advised to monitor their symptoms closely. If pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, they should seek medical advice. New symptoms, redness, or swelling should also prompt consultation. The product does not provide complete adult use directions or warnings. Patients should adhere to the dosing chart, using weight for dosing when possible, and chew the medication before swallowing. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in 24 hours or be used for more than 5 days without a doctor's guidance. Proper storage conditions include a controlled room temperature of 20-25ºC (68-77ºF), avoiding high humidity and light exposure.

Drug Information (PDF)

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

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