Infants Pain Relief

Description

Acetaminophen is provided in a suspension liquid form, delivering 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer, specifically designed for pediatric use. The product is free from ibuprofen, alcohol, aspirin, and parabens, and contains no high fructose corn syrup. It features a grape flavor and is dye-free, ensuring a palatable experience for children. The dosing system is preferred by pediatricians and is intended for use with the enclosed syringe. Each bottle contains 2 FL OZ (59 mL) of the suspension.

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, 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, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

For administration, the following steps should be followed:

1. Push air out of the syringe before inserting the syringe tip into the bottle opening.

2. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

3. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

4. Dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period. For specific dosing based on weight and age:

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

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

It is imperative to adhere to the maximum dosing limits and to use only the enclosed syringe specifically designed for this product. After use, the cap should be replaced tightly to maintain child resistance. Healthcare professionals should also be aware that this product does not contain complete warnings for adult use and should not be administered in excess of the directed dosage.

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 history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

• Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

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

Acetaminophen has been associated with the potential for 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 that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the presence of liver disease before recommending this product for use in children. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent.

Patients should be advised to discontinue use and contact a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the product are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if the product is used concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Patients should also stop use and seek medical advice if pain worsens or lasts longer than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is redness or swelling, as these may indicate a serious condition.

It is 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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional for dosing recommendations, while those aged 2 to 3 years weighing between 24 to 35 pounds may receive a dose of 5 mL. It is advised to determine the appropriate dose based on weight; if weight is not available, age may be used as a guide.

Caution is warranted due to the presence of acetaminophen, which can lead to severe liver damage if more than 5 doses are administered within a 24-hour period, the maximum daily amount. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. Healthcare professionals should be consulted prior to use if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no symptoms are apparent. It is essential to use only the enclosed syringe specifically designed for this product and to avoid using any other dosing devices.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of tailored guidance for this demographic, careful assessment and ongoing evaluation are critical to ensure the safe and effective use of this product in geriatric patients.

Pregnancy

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

Lactation

Nursing mothers are advised to consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of this product on a nursing infant are not well studied. Therefore, caution is advised when considering its use during lactation.

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 assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient 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 medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the presentation of symptoms may vary, and vigilance is necessary to ensure patient safety. The potential for serious complications underscores the importance of rapid response and appropriate management strategies.

Upon recognition of an overdose, the following steps are recommended:

1. Assessment: Evaluate the patient's condition and gather information regarding the substance involved, the amount taken, and the time of ingestion.

2. Supportive Care: Initiate supportive measures as needed, which may include monitoring vital signs and providing symptomatic treatment.

3. Decontamination: Depending on the time since ingestion and the specific circumstances, consider decontamination procedures, such as activated charcoal, if appropriate.

4. Further Management: Consult with a medical toxicologist or poison control for guidance on specific antidotes or advanced interventions that may be required.

It is essential for healthcare providers to remain alert to the potential for overdose and to act swiftly to mitigate risks associated with such incidents.

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 at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Providers should also stress the importance of adhering to the recommended dosage and caution against exceeding it, as this could lead to serious health risks.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes a printed neckband. It is essential to ensure that the neckband is intact; do not use the product if the printed neckband is broken or missing.

For optimal storage conditions, the product should be maintained at a temperature range of 68-77°F (20-25°C). Proper adherence to these storage guidelines is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

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

Drug Information (PDF)

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

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