Little Remedies Infant Fever/Pain Reliever

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It also provides relief from minor aches and pains that may be associated with conditions such as the common cold, influenza, headache, sore throat, or 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 refer to the dosage chart to determine the appropriate dose based on the child's weight or age.

Prior to administration, the product must be shaken well. The enclosed AccuSafe® syringe should be utilized for accurate dosing. To prepare the dose, remove the cap from the bottle, insert the syringe into the flow restrictor, and invert the bottle. Pull back the syringe plunger until the liquid reaches the prescribed level. The liquid should then be dispensed slowly into the child’s mouth, directed toward the inner cheek.

Dosing recommendations are as follows:

• For children weighing under 24 lbs or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

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

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period, and the total duration of use should not exceed 5 days unless directed by a physician.

After use, ensure the cap is replaced tightly to maintain child resistance. Healthcare professionals should also be aware of the overdose warning and ensure that the product is not administered beyond the specified limits.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other products containing acetaminophen, whether prescription or non-prescription, 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 administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the advised amount may lead to overdose and associated risks.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should be vigilant in monitoring for signs of liver injury in pediatric patients.

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.

In cases of severe sore throat that persists for more than two days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised to rule out serious underlying conditions.

Healthcare providers should inquire about any existing liver disease in pediatric patients prior to recommending this product. Additionally, it is essential to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Healthcare professionals should instruct caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are initially apparent.

Patients should be advised to discontinue use and consult a physician if new symptoms arise, if fever worsens or persists beyond three days, if pain intensifies or lasts more than five days, or if any redness or swelling is observed, as these may indicate a serious condition requiring further evaluation.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if a child exceeds five doses within a 24-hour period or if the product is taken concurrently with other medications containing acetaminophen. Patients should be aware of the potential for 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 and seek immediate medical assistance.

Additionally, a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

Patients are advised to stop use and consult a doctor if new symptoms arise, if fever worsens or lasts longer than three days, if pain intensifies or persists beyond five days, or if redness or swelling occurs, as these may indicate a serious underlying condition.

It is crucial to note that an overdose of this product can lead to serious liver damage. In the event of an overdose, immediate medical attention is necessary, and patients should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are present.

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 potential interactions 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 acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Little Remedies Infant Fever/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 dose is 5 mL.

It is critical to adhere to the maximum dosage guidelines, which stipulate that no more than 5 doses should be administered within a 24-hour period. Additionally, treatment should not exceed 5 consecutive days unless directed by a healthcare professional.

Caution is advised for pediatric patients with known allergies to acetaminophen or any inactive ingredients in the product. Consultation with a doctor is also recommended for children with liver disease or those concurrently taking the anticoagulant warfarin.

For accurate dosing, the enclosed AccuSafe® syringe should be utilized.

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.

Pregnancy

The available data regarding the use of this product during pregnancy do not indicate any specific warnings or precautions. The prescribing information does not state whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential and weigh the benefits against any potential risks when prescribing this product during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when administering this product to nursing mothers.

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 exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of 5 doses is exceeded within a 24-hour period, or if the product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is advisable for patients with liver disease to consult a healthcare professional. In the event of an overdose, which is defined as taking more than the recommended dose, serious liver damage may result. Immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of the medication can lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt medical attention is critical, even in the absence of noticeable signs or symptoms of overdose. It is essential for healthcare providers to monitor patients closely and initiate appropriate management procedures to mitigate potential complications associated with liver damage.

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 rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

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 that taking more than the recommended dose can lead to serious liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is critical even if no signs or symptoms are initially present.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

For pediatric patients, healthcare providers should ensure that parents or guardians do not use this medication if their child is allergic to acetaminophen or any of the inactive ingredients. Patients should be instructed to stop using the product and consult a doctor if new symptoms arise, if fever worsens or persists for more than three days, if pain intensifies or lasts longer than five days, or if any redness or swelling occurs, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dosage, and they should be reminded of the overdose warning. Additionally, healthcare providers should advise parents or guardians to consult a doctor before use if their child has liver disease or is taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25 ºC (68-77 ºF) to maintain its integrity and efficacy. Healthcare professionals are advised to check the expiration date on the bottle or box prior to use to ensure the product is within its usable timeframe.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)