Little Remedies Childrens Fever Pain Reliever

Description

Little Remedies® Children’s Fever + Pain Reliever contains acetaminophen as its active ingredient. This formulation is designed for pediatric use and is presented in a liquid dosage form with a natural cherry flavor. The product is packaged in a 4 fluid ounce (118 mL) bottle, providing a convenient option for the management of fever and pain in children.

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.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should ensure that the medication is administered according to the following guidelines. Prior to use, the bottle must be shaken well. The appropriate dose should be determined using the dosage chart based on the child's weight or age.

To administer the medication, invert the bottle and gently squeeze the liquid into the enclosed AccuSafe™ dosing cup to measure the correct amount for the child's weight and/or age. It is imperative to use only the provided AccuSafe™ dosing cup for accurate dosing.

Dosing intervals may be repeated every 4 hours as needed while symptoms persist. However, it is crucial not to exceed a total of 5 doses within any 24-hour period, and the medication should not be administered for more than 5 consecutive days unless directed by a physician.

The following dosage chart provides specific dosing recommendations:

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

• For children weighing 24-35 lb or aged 2 to under 4 years, the recommended dose is 1 teaspoon (5 mL).

• For children weighing 36-47 lb or aged 4 to under 6 years, the recommended dose is 1 ½ teaspoons (7.5 mL).

• For children weighing 48-59 lb or aged 6 to under 9 years, the recommended dose is 2 teaspoons (10 mL).

• For children weighing 60-71 lb or aged 9 to under 11 years, the recommended dose is 2 ½ teaspoons (12.5 mL).

• For children weighing 72-95 lb or aged 11 to under 12 years, the recommended dose is 3 teaspoons (15 mL).

After administration, ensure that the cap is replaced tightly to maintain child resistance. Adherence to these guidelines is essential to prevent overdose and ensure the safety of the child.

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, exceeding the recommended dosage is contraindicated, as overdose may not enhance therapeutic effects and poses a risk of liver damage.

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 advise caregivers to consult a physician prior to administration if the child has a history of liver disease. Additionally, it is important to seek guidance from a doctor or pharmacist if the child is currently prescribed warfarin, a blood-thinning medication, as interactions may pose significant risks.

Caregivers should be instructed to discontinue use and contact a healthcare provider if any of the following occur: the emergence of new symptoms, a fever that worsens or persists beyond three days, pain that intensifies or lasts longer than five days, or the presence of redness or swelling, as these may indicate a serious underlying condition requiring medical attention.

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 the maximum daily amount of more than 5 doses in 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen.

In the event of an overdose, which can lead to serious liver damage, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential, even if no symptoms are initially apparent.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is advised to avoid using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is recommended.

Patients are also advised to stop using the product and consult a doctor if new symptoms arise, if fever worsens or persists for more than 3 days, if pain intensifies or lasts longer than 5 days, or if there is any redness or swelling, as these may indicate a serious condition.

Furthermore, a sore throat warning is in place; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should seek medical advice promptly.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products that contain acetaminophen, whether prescription or over-the-counter. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not exceed the recommended dosage, and caution is advised regarding potential overdose. The following dosing guidelines are provided based on weight and age:

• For patients under 24 lb (under 2 years), consult a doctor before use.

• For patients weighing 24-35 lb (ages 2 to under 4 years), the recommended dose is 5 mL.

• For patients weighing 36-47 lb (ages 4 to under 6 years), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb (ages 6 to under 9 years), the recommended dose is 10 mL.

• For patients weighing 60-71 lb (ages 9 to under 11 years), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb (ages 11 to under 12 years), the recommended dose is 15 mL.

Administration should not exceed 5 days within any 24-hour period. Prior to use, it is essential to consult a healthcare professional if the child has a known allergy to acetaminophen or any inactive ingredients in the product, or if the child has liver disease. Additionally, consultation is advised if the child is taking the anticoagulant warfarin.

Parents and caregivers should monitor for new symptoms, worsening fever lasting more than 3 days, worsening pain lasting more than 5 days, or any signs of redness or swelling. In such cases, discontinuation of use and consultation with a healthcare provider is recommended.

It is crucial to keep this medication out of reach of children. 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 vital even if no symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Little Remedies Children's Fever Pain Reliever (acetaminophen liquid) during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

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 be closely monitored when considering the use of this product, which contains acetaminophen. It is essential 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 used concurrently with other medications containing acetaminophen.

Prior to administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. Adherence to the recommended dosage is critical; exceeding the recommended dose may not only fail to provide additional relief but also significantly increase the risk of liver damage. Therefore, careful consideration and monitoring of liver function are imperative in patients with compromised liver function to prevent potential adverse effects.

Overdosage

Taking more than the recommended dose can lead to serious liver damage. It is essential for healthcare professionals to recognize the potential severity of an overdose and to act swiftly.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is critical, even if the patient does not exhibit any noticeable signs or symptoms of overdose. Early intervention can significantly impact the outcome and mitigate the risk of severe complications.

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. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there have been reports indicating that exceeding the recommended dosage of acetaminophen can lead to serious liver damage. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222, as timely medical intervention is essential, even in the absence of noticeable signs or symptoms.

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 non-prescription. 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.

In the event of a severe sore throat that persists for more than two days, or if it is accompanied by symptoms such as fever, headache, rash, nausea, or vomiting, patients should be instructed to seek medical attention promptly. Additionally, they should be advised to discontinue use and consult a doctor if new symptoms arise, if fever worsens or lasts more than three days, if pain intensifies or lasts more than five days, or if any redness or swelling occurs, as these may indicate a serious condition.

Patients must be reminded to adhere strictly to the recommended dosage, as exceeding this may not enhance relief and could lead to liver damage. It is also essential to recommend that patients consult a doctor before use if their child has liver disease. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied with an AccuSafe™ dosing cup enclosed. It should be stored at a temperature range of 20-25ºC (68-77ºF). Healthcare professionals are advised to inspect the product prior to use; specifically, the printed shrink band on the bottle must not be broken or missing. Additionally, it is essential to check the expiration date on the bottle or box before administration to ensure the product's integrity and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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