Little Fevers Infant Berry Fever/Pain Reliever

Description

Little Fevers® by Little Remedies® is a medicated formulation specifically designed for infants, serving as an infant fever and pain reliever. The active ingredient is acetaminophen, which is known for its analgesic and antipyretic properties. This product is free from dyes, artificial flavors, alcohol, saccharin, and gluten, ensuring a gentle option for young patients. It features a natural berry flavor to enhance palatability. The dosage form is a liquid suspension, provided in a 2 fluid ounce (59 mL) bottle.

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 instruct caregivers to shake the medication well before use. The appropriate dose should be determined using the dosage chart provided, prioritizing weight for accuracy; if weight is not available, age may be used as a secondary measure.

Caregivers must utilize only the enclosed AccuSafe™ syringe for administration. The use of any other syringe, dropper, spoon, or dosing device is not recommended. To administer the medication, caregivers should remove the cap, attach the syringe to the flow restrictor, and invert the bottle. They should then pull back the syringe until it is filled to the prescribed level and slowly dispense the liquid into the child’s mouth, directing it toward the inner cheek.

Dosing may be repeated every 4 hours as needed while symptoms persist, but caregivers must not exceed 5 doses within a 24-hour period to avoid the risk of overdose. After administration, the cap should be replaced tightly to ensure child resistance.

Dosage Chart:

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

• For children weighing between 24-35 lbs and aged 2-3 years, the recommended dose is 5.0 mL.

• For children weighing between 36-47 lbs and aged 4-5 years, the recommended dose is 7.5 mL.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other products containing acetaminophen, whether prescription or non-prescription, due to the risk of acetaminophen overdose and potential liver damage. 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.

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 also 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 further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily amount of 5 doses within a 24-hour period or if it is taken concurrently with other medications containing acetaminophen.

It is crucial to avoid using this product in conjunction with any other acetaminophen-containing products, whether prescription or non-prescription. Patients should consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications. Additionally, this product should not be administered to patients with a known allergy to acetaminophen or any of the inactive ingredients included in the formulation.

Patients should be vigilant for severe sore throat symptoms that persist for more than 2 days or are accompanied by fever, headache, rash, nausea, or vomiting, as these may indicate a need for prompt medical consultation.

When using this product, it is imperative that patients do not exceed the recommended dosage. Overdosing may not only fail to provide additional relief but can also lead to serious liver damage. In the event of an overdose, immediate medical assistance should be sought, and patients are advised to contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical, even if no signs or symptoms of overdose are initially apparent.

Patients should discontinue use and consult a healthcare provider if new symptoms arise, if fever worsens or persists beyond 3 days, if pain intensifies or lasts more than 5 days, or if redness or swelling occurs, as these may be indicative of a serious condition.

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 non-prescription. The concurrent use of multiple acetaminophen-containing products can lead to an increased risk of hepatotoxicity. Monitoring for signs of liver damage is advised in patients who may inadvertently exceed the recommended dosage of acetaminophen.

Packaging & NDC

Below are the non-prescription pack sizes of Little Fevers Infant Berry 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), the recommended dose is 5.0 mL, while for those weighing 36-47 lbs (ages 4-5), the recommended dose is 7.5 mL.

It is important to note that severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Healthcare professionals should advise parents to consult a doctor if their child has liver disease or is taking the blood-thinning medication warfarin. Additionally, this product should not be used in conjunction with any other products containing acetaminophen.

For accurate dosing, the enclosed AccuSafe syringe should be used; other syringes, droppers, spoons, or dosing devices are not recommended. If necessary, doses may be repeated every 4 hours while symptoms persist, but the total should not exceed 5 doses in any 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the insert does not provide guidance tailored to this population. The product is primarily intended for infants, and as such, it lacks directions or complete warnings for adult use, including geriatric patients.

Healthcare providers should exercise caution when considering the use of this product in elderly patients, given the absence of established safety and efficacy data in this demographic. Monitoring for potential adverse effects is recommended, and any decision to use the product in geriatric patients should be made with careful consideration of the individual patient's health status and needs.

Pregnancy

The available data does not indicate any specific warnings, precautions, or dosage modifications for the use of this product during pregnancy. Healthcare professionals should consider the absence of documented risks when prescribing this product to pregnant patients. However, as with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. It is advisable for women of childbearing potential to discuss their pregnancy status and any potential risks with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements addressing the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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. The recommended dosage should not be exceeded, as taking more than the recommended dose may not enhance therapeutic relief and could lead to significant liver damage. Careful adherence to dosing guidelines is crucial to minimize the risk of adverse effects in patients with compromised liver function.

Overdosage

Taking more than the recommended dose of this 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 crucial, even in the absence of noticeable signs or symptoms of overdose. Early intervention can significantly impact the management and outcome of potential liver injury.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been noted in patients taking acetaminophen, particularly among those with underlying liver disease or those who exceed the recommended dosage. Allergic reactions, including anaphylaxis, have also been reported following the use of acetaminophen. Furthermore, there have been instances of renal impairment associated with acetaminophen use, especially in patients with pre-existing kidney conditions.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 whether a drug contains acetaminophen, 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 present 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 stop using the product and consult a doctor if new symptoms arise, if fever worsens or lasts 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.

Patients must be reminded not to exceed the recommended dosage, as taking more than the advised amount may not enhance relief and could lead to liver damage. It is also essential to recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist before use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that requires careful handling to ensure safety and efficacy. It should be stored at a temperature range of 20-25°C (68-77°F). To maintain child resistance, the cap must be replaced tightly after each use. Users are advised not to use the product if the printed shrinkband on the bottle is broken or missing, as this may compromise the integrity of the product. Additionally, it is essential to check the expiration date on the bottle or box prior to use to ensure the product is within its effective period.

Additional Clinical Information

Patients should be advised that the medication is administered orally using the enclosed AccuSafe syringe. The syringe should be filled to the prescribed level and the liquid dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. If a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, medical attention should be sought promptly. Patients should discontinue use and consult a doctor if new symptoms arise, if fever worsens or lasts more than 3 days, if pain intensifies or lasts more than 5 days, or if redness or swelling occurs. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center (1-800-222-1222) is essential.

Drug Information (PDF)

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

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