Childrens Pain and Fever Cherry Flavor

Description

Walgreens Children's Pain & Fever Oral Suspension contains acetaminophen as the active ingredient, with a strength of 160 mg per 5 mL. This formulation is presented as an oral suspension, specifically designed for use as a pain reliever and fever reducer. The product is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for children aged 2 to 11 years. It is available in a cherry flavor and is packaged in a volume of 4 FL OZ (118 mL). The National Drug Code (NDC) for this product is 0363-0322-24. This formulation is comparable to Children's Tylenol® and is distributed by Walgreen Co.

Uses and Indications

This drug is indicated for the temporary 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

Shake the product well before use. Healthcare professionals should determine the appropriate dose based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The following dosing chart provides specific recommendations:

• For patients weighing under 24 lb or under 2 years of age, consult a physician for dosing guidance.

• For patients weighing 24-35 lb or aged 2 to 3 years, administer 5 mL (1 teaspoon).

• For patients weighing 36-47 lb or aged 4 to 5 years, administer 7.5 mL (1.5 teaspoons).

• For patients weighing 48-59 lb or aged 6 to 8 years, administer 10 mL (2 teaspoons).

• For patients weighing 60-71 lb or aged 9 to 10 years, administer 12.5 mL (2.5 teaspoons).

• For patients weighing 72-95 lb or aged 11 years, administer 15 mL (3 teaspoons).

If necessary, doses may be repeated every 4 hours while symptoms persist. However, do not exceed 5 doses within a 24-hour period. Treatment should not extend beyond 5 days unless directed by a healthcare provider.

It is essential to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be utilized.

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 administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained within 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 in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen is associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include 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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, healthcare professionals should be consulted without delay.

Healthcare providers should inquire about the presence of liver disease before recommending this product for use in children. Additionally, it is advisable to consult a doctor or pharmacist prior to administration if the child is currently taking the anticoagulant warfarin.

Patients should be advised to discontinue use and contact a healthcare professional if any of the following occur: worsening pain that lasts longer than 5 days, worsening fever that persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum recommended dosage of acetaminophen, which is more than 5 doses within a 24-hour period, or when taken concurrently with other medications containing acetaminophen. Patients should be aware of the potential for serious allergic reactions, which may manifest as severe skin reactions including skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Overdosage of acetaminophen poses a significant risk of liver damage. In cases of suspected overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as timely medical intervention is essential for both adults and children, even in the absence of noticeable symptoms.

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

Before using this medication, it is recommended that patients consult a healthcare provider if there is a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

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 and associated hepatotoxicity may be heightened. 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 Childrens Pain and Fever Cherry Flavor (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age who weigh less than 24 lb should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lb, the recommended dose is 5 mL (1 tsp). For those aged 4 to 5 years weighing 36-47 lb, the dose increases to 7.5 mL (1 1/2 tsp). Children aged 6 to 8 years weighing 48-59 lb should receive 10 mL (2 tsp), while those aged 9 to 10 years weighing 60-71 lb may take 12.5 mL (2 1/2 tsp). Finally, for adolescents aged 11 years and older weighing 72-95 lb, the recommended dose is 15 mL (3 tsp).

Safety concerns include a liver warning indicating that severe liver damage may occur if a child takes more than 5 doses in 24 hours or if used concurrently with other acetaminophen-containing products. There is also an allergy alert, as acetaminophen may cause severe skin reactions, including reddening, blisters, and rash; in such cases, use should be discontinued immediately, and medical help sought. A sore throat warning advises that 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. The product should not be used in children with known allergies to acetaminophen or any inactive ingredients. Additionally, a doctor should be consulted before use if the child has liver disease or is taking the blood-thinning medication warfarin.

Dosing instructions recommend using weight for dosing when possible; otherwise, age may be used. Doses may be repeated every 4 hours as needed while symptoms persist, but no more than 5 doses should be given in a 24-hour period. The product should not be administered for more than 5 days unless directed by a doctor.

Geriatric Use

There is no specific information regarding the use of Children's Pain and Fever Cherry Flavor (acetaminophen suspension) in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to consider individual patient factors, including the presence of comorbidities and the potential for altered pharmacokinetics in this population. Monitoring for efficacy and safety is recommended, as elderly patients may have different responses to treatment compared to younger populations. Additionally, healthcare providers should be vigilant for any adverse effects that may arise during therapy in geriatric patients.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. The absence of safety concerns, dosage modifications, or special precautions in the labeling indicates a lack of comprehensive clinical studies assessing the drug's effects on fetal outcomes. Therefore, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks are adequately evaluated and managed.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the risk of infant exposure.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines to prevent severe liver damage. Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is advised against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy during treatment.

Overdosage

Taking more than the recommended dose of this medication may lead to serious health consequences, including potential liver damage. It is imperative that healthcare professionals remain vigilant regarding the risks associated with overdose.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay; the national hotline can be reached at 1-800-222-1222. Prompt intervention is crucial, as quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Healthcare professionals should ensure that patients and caregivers are aware of these risks and the importance of adhering to prescribed dosages to prevent adverse outcomes.

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, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, reports indicate that exceeding the recommended dosage of acetaminophen may lead to liver damage. In cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent. It is recommended to contact a Poison Control Center or seek medical help without delay.

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 made aware that this product should not be used 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 the child's pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, or if new symptoms arise, including any signs of redness or swelling, as these may indicate a serious condition.

It is crucial 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. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe use of this product.

Storage and Handling

The product is supplied in a carton that contains essential information for use. It is important to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. Users are advised to retain the carton to access the full directions for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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