Childrens Pain Relief

Description

Acetaminophen, an active ingredient at a dosage of 160 mg, is formulated as chewable tablets intended for pain relief and fever reduction. These tablets are grape-flavored and packaged in a container containing 24 chewable tablets. The product is specifically indicated for use in children aged 2 to 11 years. It is important to note that this formulation is free from ibuprofen and aspirin. The packaging includes a tamper-evident feature, with a statement advising against use if the imprinted safety seal under the cap is broken or missing.

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 instructions must be followed carefully. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight or age.

Patients should not exceed the recommended dosage. The maximum frequency of administration is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period. Treatment should not extend beyond 5 days unless directed by a physician.

For administration, tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole.

Dosage Chart:

• Weight (lb) / Age (yr) / Dose (chewable tablets)

  • Under 24 / Under 2: Ask a doctor

  • 24-35 / 2-3: 1 tablet

  • 36-47 / 4-5: 1 1/2 tablets

  • 48-59 / 6-8: 2 tablets

  • 60-71 / 9-10: 2 1/2 tablets

  • 72-95 / 11: 3 tablets

Dosing should be adjusted as necessary based on clinical judgment and patient response, and any deviations from the recommended guidelines should be discussed with a healthcare provider.

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.

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage of 5 doses within 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise patients and caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

Acetaminophen may also induce 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 without delay.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly to rule out any serious underlying conditions.

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, before recommending this product. Additionally, it is advisable to consult a doctor or pharmacist if the patient is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help right away, regardless of whether symptoms are present, as prompt intervention is vital for both adults and children.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious condition requiring further 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, blisters, 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 not to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, and should confirm with a doctor or pharmacist if uncertain about the presence of acetaminophen in other medications. This product should not be used by individuals who are allergic to acetaminophen or any of its inactive ingredients.

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

While using this product, it is crucial not to exceed the recommended dosage. Patients should stop 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 cases of overdose, immediate medical help should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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 may be heightened. 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 Childrens Pain Relief (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. For children aged 2 to 3 years, the recommended dosage is 1 tablet for those weighing between 24 to 35 lbs. For children aged 4 to 5 years, the dosage increases to 1 1/2 tablets for those weighing 36 to 47 lbs. Children aged 6 to 8 years should receive 2 tablets for weights of 48 to 59 lbs, while those aged 9 to 10 years may take 2 1/2 tablets for weights of 60 to 71 lbs. For an 11-year-old weighing between 72 to 95 lbs, the dosage is 3 tablets.

Dosing instructions specify that no more than 5 doses should be administered within a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare professional. Doses may be repeated every 4 hours as needed while symptoms persist.

Warnings include the risk of severe liver damage if more than 5 doses are taken in 24 hours. Parents should seek medical advice if a child's sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, consultation with a doctor is advised if the child has liver disease or is taking the anticoagulant warfarin.

Safety precautions emphasize keeping the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial, as prompt attention is necessary for both children and adults.

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

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 product 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 insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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, 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 health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 in the event of an overdose, 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.

Patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than 5 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

When using this product, patients must be cautioned against exceeding the recommended dosage. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to 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 to 86°F). Care should be taken to avoid exposure to high humidity during storage. For reference, 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 needing 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 important to emphasize that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Drug Information (PDF)

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

View product document (PDF)