Lil Drug Store Childrens Pain and Fever

Description

Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever, containing 160 mg of acetaminophen per 5 mL. This medication is indicated for use in pediatric patients aged 2 to 11 years. The product is presented in a cherry flavor and is packaged in a 4 FL OZ (118 mL) bottle.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

Prior to administration, the product must be shaken well. It is essential to utilize only the enclosed dosing cup specifically designed for this product; no other dosing devices should be employed to ensure accurate dosing.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is critical not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Dosage Chart:

• For patients weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Healthcare professionals should ensure that patients do not exceed the maximum dosage limits and should monitor for any signs of overdose.

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 known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

• Exceeding the recommended dose is contraindicated, as it may increase the risk of adverse effects.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted if the product is used concurrently with other medications containing acetaminophen.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

If a child presents with a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

General precautions should be observed prior to administration. Caregivers should be advised to consult a physician if the child has a history of liver disease. Furthermore, it is important to inquire about any concurrent use of blood-thinning medications, such as warfarin, before administering this product. Adherence to the recommended dosage is critical to ensure safety.

In cases of overdose, immediate medical attention is necessary. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as rapid intervention is crucial.

Healthcare professionals should also advise caregivers to discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take acetaminophen concurrently with other medications containing acetaminophen. In cases of overdose, which involves taking more than the recommended dose, patients are advised to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222), as prompt medical attention is critical even in the absence of noticeable signs or symptoms.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use and seek medical help immediately.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

It is important to avoid using this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, this product should not be used by individuals who are allergic to acetaminophen or any of its inactive ingredients.

Patients are advised to stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than five days, or if fever intensifies or lasts more than three days, as these may indicate 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 containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose may arise from unintentional duplication of therapy. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 11 years may receive specific dosing based on weight. For children weighing under 24 lb (under 2 years), consultation with a doctor is advised prior to use. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL; for 36-47 lb (ages 4-5 years), the dose is 7.5 mL; for 48-59 lb (ages 6-8 years), the dose is 10 mL; for 60-71 lb (ages 9-10 years), the dose is 12.5 mL; and for 72-95 lb (age 11 years), the dose is 15 mL.

It is important to note that no more than 5 doses should be administered within a 24-hour period, and treatment should not exceed 5 days unless directed by a healthcare professional. Prior to use, consultation with a doctor is recommended if the child has liver disease. Additionally, if the child is taking the anticoagulant warfarin, it is advisable to seek guidance from a doctor or pharmacist before administration.

Geriatric Use

Elderly patients may use LIL DRUG STORE CHILDREN'S PAIN AND FEVER (acetaminophen suspension); however, no specific information regarding geriatric use is provided in the drug insert. The product is primarily indicated for children aged 2-11 years, and there are no dosage adjustments, safety concerns, or special precautions mentioned for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of specific data on its use in this population. Monitoring for efficacy and potential adverse effects is advisable, given the absence of established guidelines for elderly 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 ensure that it is appropriate for their individual circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on nursing infants are not well studied; therefore, caution is advised.

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 more than 5 doses in 24 hours is exceeded or if this 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 may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that prompt medical intervention is essential, even in the absence of noticeable signs or symptoms.

Immediate action is required in cases of suspected overdose. It is imperative to seek medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay. The urgency of obtaining medical help cannot be overstated, as early intervention may mitigate potential complications associated with liver injury.

Healthcare providers should monitor patients closely for any signs of liver dysfunction and initiate appropriate management protocols as necessary.

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 assessment of potential risks associated with the use of the compound in these contexts.

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 immediately and seek medical assistance.

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 nonprescription. 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. Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if there is any redness or swelling, or if pain worsens or persists beyond five days. Additionally, patients should be advised to stop use and consult a doctor if a fever worsens or lasts more than three days, as these may indicate a serious underlying condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, as outlined in the overdose warning. Healthcare providers should also 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 prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy.

Additional Clinical Information

The medication is administered orally, with a recommended dosing schedule that allows for repeat doses every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Additionally, it should not be used for more than 5 consecutive days unless directed by a healthcare professional.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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