Junior Acetaminophen

Description

Acetaminophen is the active ingredient in this formulation, which serves as a pain reliever and fever reducer. Each chewable tablet contains 160 mg of acetaminophen, and the product is available in a package of 24 tablets. The tablets are naturally and artificially flavored with grape flavor. This formulation is both aspirin-free and ibuprofen-free, making it suitable for individuals who require alternatives to these common analgesics.

The product is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA. A tamper evident warning is included, stating: "TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING." Additionally, it is noted that this product compares to the active ingredient in Children’s Tylenol® Chewables, although it is not manufactured or distributed by McNeil Consumer Healthcare, the owner of the registered trademark.

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 pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines:

For patients weighing less than 24 lbs or under 2 years of age, consultation with a physician is required prior to administration. For patients weighing between 24-35 lbs (ages 2-3 years), the recommended dose is 1 tablet. For those weighing 36-47 lbs (ages 4-5 years), the dose is 1½ tablets. Patients weighing 48-59 lbs (ages 6-8 years) should receive 2 tablets, while those weighing 60-71 lbs (ages 9-10 years) should be administered 2½ tablets. For patients weighing 72-95 lbs (age 11 years), the recommended dose is 3 tablets.

The product must be chewed completely before swallowing; it should not be swallowed whole. Dosing 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. Healthcare professionals should ensure that patients do not receive more than the directed amount, as indicated in the overdose warning. For any uncertainties regarding dosing, consultation with a physician is advised.

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 used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to serious health risks, including 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 five 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, blistering, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a sore throat is severe, persists for more than two 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 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.

Caregivers should also be advised to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

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 it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blistering, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor 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 there is any redness or swelling, as these may indicate a serious condition.

It is also recommended that patients consult a doctor before using this product if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 necessitates careful monitoring of all medications being taken. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not be given this product without consulting a doctor. For children aged 2 to 3 years weighing 24-35 lbs, the recommended dosage is 1 tablet. For those aged 4 to 5 years weighing 36-47 lbs, the dosage increases to 1½ tablets. Children aged 6 to 8 years weighing 48-59 lbs should receive 2 tablets, while those aged 9 to 10 years weighing 60-71 lbs may take 2½ tablets. For children aged 11 years weighing 72-95 lbs, the recommended dosage is 3 tablets. Dosage may also be directed by a physician.

Healthcare professionals should be aware of the following warnings: this product contains acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within a 24-hour period. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blistering, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Consultation with a doctor is advised if the child has liver disease or is taking the blood-thinning medication warfarin.

It is crucial to adhere to the recommended dosage and not exceed the maximum daily amount. The appropriate dose should be determined using the provided weight chart; if weight is not available, age may be used as a guide. Tablets should be chewed completely and not swallowed whole. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are thoroughly evaluated.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

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 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 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 the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals are advised to remain vigilant and act swiftly, as timely medical attention can significantly influence the outcome of an overdose situation. It is crucial to monitor the patient closely for any developing symptoms and to provide comprehensive support as necessary.

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 severe skin reactions associated with acetaminophen use. These reactions may manifest as symptoms including skin reddening, blistering, and rash. It is advised that if a skin reaction occurs, the user should discontinue use and seek medical assistance immediately.

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

Patients should be instructed not to exceed the recommended dosage, as this could lead to serious health risks. Additionally, healthcare providers should encourage patients to consult with a doctor before using the medication if their child has liver disease, as this condition may affect the safety and efficacy of the treatment.

Furthermore, it is essential for healthcare providers to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This precaution helps to prevent potential drug interactions that could compromise patient safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at room temperature, ensuring that it is kept away from high humidity environments. Additionally, the product must be protected from light to maintain its integrity. For tracking purposes, the expiration date and lot number can be found on the end flap of the packaging.

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 immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)