Infants Pain Reliever

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches and pains associated with various conditions, including the common cold, influenza, headache, sore throat, immunizations, and toothache.

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

Dosage and Administration

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided below, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

The liquid should be filled to the specified dose level using only the enclosed dropper. It is critical to dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. If necessary, the dose may be repeated every 4 hours while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period.

To maintain child resistance, the original bottle cap should be replaced after each use. The enclosed dropper must be used exclusively for dosing this product; no other dosing devices should be utilized. After each use, the dropper should be rinsed thoroughly.

Dosing Chart:

• For children weighing under 24 lbs (under 2 years of age): Consult a doctor for the appropriate dose.

• For children weighing 24-35 lbs (ages 2-3 years): Administer 2 droppersful (0.8 mL + 0.8 mL).

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, exceeding the recommended dosage is contraindicated, as it may not enhance therapeutic effects and could result in serious health complications.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

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 healthcare professional promptly.

Overdose of this product can lead to significant liver damage. If an overdose is suspected, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Quick medical attention is crucial, even if no signs or symptoms are immediately apparent.

Healthcare professionals should advise caregivers to consult a physician before administering this product if the child has a history of liver disease. Additionally, it is important to inquire about any concurrent use of blood-thinning medications, such as warfarin, before use. Caregivers must be cautioned against exceeding the recommended dosage, as taking more than directed may not enhance relief and could result in serious health complications.

Caregivers should be instructed to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts longer than 3 days. These symptoms 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 related to liver health. The product contains acetaminophen, and severe liver damage may occur if a child takes more than five doses within a 24-hour period, which is the maximum daily amount. Additionally, the risk of liver damage increases if the product is used concurrently with other medications containing acetaminophen.

In the event of a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. It is also contraindicated for use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended.

Before using this product, it is important for patients to seek medical advice if the child has liver disease or is taking the blood-thinning medication warfarin.

While using this product, patients must adhere to the recommended dosage. Exceeding the recommended dose may not provide additional relief and could lead to serious health complications. Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever worsens or lasts more than three days, as these may indicate a serious condition.

In cases of overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Quick medical attention is critical, even if no signs or symptoms are immediately apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the child is concurrently taking warfarin, a blood-thinning medication. This is important to ensure appropriate monitoring and to mitigate the risk of potential interactions that could affect coagulation parameters.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should consult a doctor before use. For children weighing 24-35 lbs (ages 2-3 years), the recommended dosage is 2 droppersful (0.8 + 0.8 mL).

Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount when combined with other medications containing acetaminophen. It is essential to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin.

Parents and caregivers should be aware that taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt medical attention is critical, even if no signs or symptoms are present.

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 carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of geriatric patients.

Pregnancy

The available data does not indicate any specific warnings or precautions regarding the use of this product during pregnancy. There is no information provided that contraindicates the use of this product in pregnant patients, nor are there any identified risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant have been specified. Healthcare professionals should consider the absence of data when advising women of childbearing potential and pregnant patients regarding the use of this product.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product on a nursing infant are not well studied; therefore, caution is advised.

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 using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the patient exceeds five doses within a 24-hour period, as this represents the maximum daily dosage. Additionally, caution is advised when administering this product alongside other medications that also contain acetaminophen, as this may further increase the risk of liver injury.

In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms of overdose, to mitigate potential liver damage.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of the effects may not be immediately apparent, as symptoms can be delayed or absent initially.

It is imperative that individuals who suspect an overdose seek medical assistance promptly. Contacting a Poison Control Center or obtaining medical help without delay is crucial for effective management. Quick medical attention is essential, even in the absence of noticeable signs or symptoms, to mitigate potential complications and ensure appropriate treatment is administered.

Healthcare providers should remain vigilant and prepared to assess and manage any cases of overdose, prioritizing patient safety and timely intervention.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, if a fever worsens or lasts more than three days, patients should be advised to stop use and consult a doctor, as these may indicate a serious underlying condition.

It is crucial to emphasize the importance of adhering to the recommended dosage, as exceeding this may not enhance relief and could lead to serious health complications. Healthcare providers should also recommend that patients consult a doctor prior to use if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist before using this product.

Storage and Handling

This product is supplied in a tamper-evident container. Healthcare professionals are advised not to use the product if the printed inner cap seal is broken or missing. Prior to administration, it is essential to shake the product well.

For optimal storage, the product should be kept at room temperature, within the range of 15º to 30ºC (59º to 86ºF). It is important to protect the product from freezing to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

Drug Information (PDF)

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

View product document (PDF)