Infants Pain and Fever

Description

No description information is available for the drug.

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

Patients should adhere strictly to the prescribed dosage and administration guidelines. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided, prioritizing weight for dosing whenever possible; if weight is not available, age may be used as a secondary reference.

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. Invert the bottle and pull the yellow part of the syringe to the correct dose.

3. Administer the liquid slowly into the child’s mouth, directing it toward the inner cheek.

Dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period. It is imperative to replace the cap tightly after use to ensure child resistance.

The dosing chart is as follows:

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

• For children weighing between 24-35 lbs (2-3 years of age), the recommended dose is 5 mL.

Only the enclosed syringe designed for this product should be used for dosing; no other dosing devices are permitted.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage while using this product is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen.

Acetaminophen has been associated with severe skin reactions, which may 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.

Healthcare providers should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Before administering this product, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, healthcare professionals should inquire about the use of anticoagulants, such as warfarin, as interactions may occur.

In cases of suspected overdose, immediate medical attention is critical. Healthcare professionals should instruct caregivers to contact a Poison Control Center (1-800-222-1222) without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a physician 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 underlying condition that requires 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 be vigilant for signs of liver injury.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to 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 healthcare professional promptly.

Additional precautions include stopping use and consulting 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 is observed, as these may indicate a serious condition.

Patients with liver disease should seek medical advice before using this product. Furthermore, it is recommended that patients taking the blood-thinning medication warfarin consult a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. The combination may lead to an interaction that could affect the efficacy and safety of warfarin therapy. Monitoring of coagulation parameters may be warranted to ensure appropriate management of anticoagulation levels.

No additional drug interactions or laboratory test interactions have been identified for this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 24 lbs and under 2 years of age should consult a doctor before use. For children weighing between 24-35 lbs and aged 2-3 years, the recommended dosage is 5 mL.

Severe liver damage may occur if a child exceeds 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Additionally, 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 administering this medication, it is advisable to 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 should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt medical attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised when considering the use of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to offer guidance tailored to the individual patient's needs. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

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 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. 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 poses a 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 safety and efficacy of the treatment in individuals with compromised liver function.

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 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 supportive care as necessary.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs, as well as specific interventions based on the substance involved. Continuous assessment and readiness to address complications are vital components of effective overdose management.

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

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other products containing 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 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.

Patients should be reminded to adhere strictly to the recommended dosage to avoid the risk of overdose. Additionally, healthcare providers should advise patients to consult a doctor before using this medication if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Lastly, 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.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)