Chewable Acetaminophen

Description

LEADER™ Children's Chewable Acetaminophen is a pain reliever and fever reducer available in a dosage form of 160 mg chewable tablets. The product is specifically formulated for children aged 2 to 11 years and features a bubble gum flavor. Each bottle contains 24 chewable tablets that are aspirin-free and ibuprofen-free. It is recommended that the tablets be chewed or crushed completely before swallowing.

The product is distributed by Cardinal Health, located in Dublin, Ohio, and is comparable to Children's Tylenol® Chewables in terms of active ingredient. A tamper evident warning is included, advising against use if the safety seal under the cap is broken or missing. The product is backed by a 100% money-back guarantee. For further information, customers can visit the website at www.myleader.com or contact customer service at 1-800-200-6313.

LEADER™ and its associated trademarks, including Essential to Care™, are registered trademarks of Cardinal Health, with all rights reserved.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. 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 specific dosing should be determined based on the patient's weight or age. Healthcare professionals are advised to refer to the following dosage chart to ascertain the appropriate dose:

• For patients weighing under 24 lb or under 2 years of age, it is recommended to consult a doctor for dosing guidance.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 1 chewable tablet.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 1 ½ chewable tablets.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 2 chewable tablets.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 2 ½ chewable tablets.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 3 chewable tablets.

Patients should chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period. It is essential to adhere strictly to the recommended dosing guidelines and not to exceed the directed amount.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children who take this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they use it concurrently with other medications containing acetaminophen.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise parents to consult a physician if their child experiences a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

It is recommended that a doctor be consulted prior to use if the child has a history of liver disease. Additionally, healthcare providers should inquire about the use of the blood-thinning medication warfarin before recommending this product.

In cases of overdose, immediate medical attention is crucial. Parents should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether any signs or symptoms are present.

Patients should be advised to discontinue use and consult a physician if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if any new symptoms arise, or if there is any redness or swelling.

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 may also experience severe skin reactions, which can 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.

Additionally, a warning is issued for patients experiencing a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting; such individuals should consult a healthcare professional without delay.

Common adverse reactions necessitating medical consultation include worsening pain that lasts beyond five days, fever that persists for more than three days, the emergence of new symptoms, or the presence of redness or swelling.

Patients with a history of liver disease should seek medical advice prior to using this product. Furthermore, it is advisable for patients taking the anticoagulant warfarin to consult a healthcare provider or pharmacist before 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 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 Chewable Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is indicated for pediatric patients aged 2 to 11 years. The recommended dosages for chewable tablets based on weight and age are as follows: for children under 24 lb and under 2 years, consultation with a doctor is advised; for those weighing 24-35 lb (ages 2-3 years), the dose is 1 tablet; for 36-47 lb (ages 4-5 years), the dose is 1 1/2 tablets; for 48-59 lb (ages 6-8 years), the dose is 2 tablets; for 60-71 lb (ages 9-10 years), the dose is 2 1/2 tablets; and for 72-95 lb (age 11 years), the dose is 3 tablets.

Healthcare professionals should instruct caregivers not to exceed the recommended dosage, which allows for a repeat dose every 4 hours while symptoms persist, with a maximum of 5 doses in 24 hours. Treatment should not exceed 5 days unless directed by a physician.

There is a liver warning associated with this product, as severe liver damage may occur if more than 5 doses are taken in 24 hours. An allergy alert is also present, as acetaminophen may cause severe skin reactions; if such a reaction occurs, use should be discontinued immediately, and medical assistance sought.

A sore throat warning is included; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

Before use, caregivers should consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical help or contact with a Poison Control Center is essential, as prompt attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against using this product if they are allergic to acetaminophen or any of the inactive ingredients contained within. It is essential for healthcare providers to inquire about any existing liver disease in pregnant patients, as this may influence the safety and efficacy of the product. Additionally, caution is warranted if the patient is concurrently taking warfarin, a blood-thinning medication, and consultation with a doctor or pharmacist is recommended prior to use.

The product is not intended for adult use, and therefore, specific directions or warnings for adult patients are not provided. Pregnant patients should also be informed that the product should not be administered for more than 5 days unless directed by a healthcare professional. These precautions are critical to ensure the safety of both the mother and the developing fetus.

Lactation

Nursing 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 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 be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, 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 adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate care based on clinical judgment and established protocols.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any medication, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, patients should be advised to stop use and seek medical advice if their fever worsens or lasts longer than three days. It is also important to inform patients to stop use and consult a doctor if they experience any new symptoms, or if they notice redness or swelling.

Additionally, healthcare providers should recommend that patients consult a doctor before using this medication if their child has liver disease. Patients should also be advised to speak with a doctor or pharmacist before use 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 should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to avoid exposure to high humidity during storage. For tracking purposes, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with tablets required to be chewed or crushed completely before swallowing. Dosing can be repeated every 4 hours as long as symptoms persist, but should not exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

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 in the event of an overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no signs or symptoms are initially apparent.

Drug Information (PDF)

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

View product document (PDF)