Infants Pain Reliever

Description

Acetaminophen is provided in an oral suspension form, delivering 160 mg of acetaminophen per 5 mL. This formulation is free from alcohol, aspirin, and ibuprofen, making it suitable for a wide range of patients. The product features a cherry flavor, enhancing palatability while maintaining its therapeutic efficacy.

Uses and Indications

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

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

Dosage and Administration

This product is intended for pediatric use only, and healthcare professionals should ensure that the dosage is determined based on the child's weight or age, as outlined in the dosage chart.

Prior to administration, the product must be shaken well. The enclosed syringe is the only appropriate dosing device; other syringes, droppers, spoons, or dosing devices should not be used.

To administer the medication, remove the cap and insert the syringe into the hole at the top of the bottle. Turn the bottle upside down and pull back the syringe plunger until it is filled to the prescribed level. If the plunger is pulled past the prescribed level, invert the assembly to the upright position on a flat surface and gently push the plunger back until the desired level is reached. The liquid should be dispensed slowly into the child's mouth, directed towards the inner cheek.

Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Continuous use beyond 5 days is not recommended unless directed by a physician. After use, ensure the cap is replaced tightly to maintain child resistance.

The following dosage chart provides guidance for dosing:

• For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing between 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

Healthcare professionals should advise caregivers to adhere strictly to the dosing instructions and to seek medical advice if there are any uncertainties regarding the appropriate dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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 dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that the maximum daily dosage for children is five doses within a 24-hour period. Caution is warranted if this product is administered concurrently with other medications containing acetaminophen, as this may increase the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: the emergence of new symptoms, the presence of redness or swelling, worsening pain lasting more than five days, or a fever that worsens or persists for more than three days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential.

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 avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, 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 dose. Patients should stop use and consult a doctor if new symptoms arise, if redness or swelling is observed, if pain worsens or lasts more than 5 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition.

In the event of an overdose, which may lead to liver damage, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) should be made. Quick medical attention is essential, 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

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 2 years of age who weigh less than 24 lb should be advised to consult a doctor before administration. For children aged 2 to 3 years weighing between 24-35 lb, the recommended dose is 5 mL.

Healthcare professionals should be aware of several important warnings. Severe liver damage may occur if a child exceeds 5 doses within a 24-hour period, which is the maximum daily amount. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Furthermore, if a child experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a doctor is recommended.

When administering this medication, it is crucial to use only the enclosed syringe and to avoid any other dosing devices. Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Prolonged use beyond 5 days should only occur under the direction of a healthcare professional.

Geriatric Use

There is no specific information regarding the use of this product in geriatric patients. The product is primarily indicated for infants and children, and the prescribing information does not provide any details on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients.

Healthcare providers should exercise caution when considering the use of this product in geriatric patients, given the absence of data. It is advisable to monitor these patients closely for any potential adverse effects or complications, as the lack of specific guidance necessitates a careful assessment of individual patient needs and responses.

Pregnancy

Pregnant patients may use this product as there are no specific warnings or precautions regarding its use during pregnancy mentioned in the provided text. The prescribing information does not indicate whether the product is contraindicated in pregnancy or if there are any risks to the fetus associated with its use during this period. Additionally, no dosage modifications or special precautions for pregnant individuals are provided. Healthcare professionals should consider the absence of data when counseling women of childbearing potential regarding the use of this product during pregnancy.

Lactation

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

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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is crucial to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily allowance. Additionally, caution is advised when considering the use of this medication in conjunction with other products containing acetaminophen, as this combination may also result in severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate management procedures as necessary.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and timely intervention in cases of suspected 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

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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 even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. 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 to avoid using 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 new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dose, reiterating the overdose warning. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease or 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 temperature range of 20-25ºC (68º-77ºF) and to avoid refrigeration. To ensure child resistance, the cap must be replaced tightly after each use. For traceability, the lot number and expiration date are located on the bottom panel of the container.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

Patients should be counseled to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential even if no symptoms are apparent.

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.

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