Childrens Pain and Fever, Grape 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 the relief of pain and reduction of fever. The product is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for children aged 2 to 11 years. It is flavored with grape and is available in a volume of 4 FL OZ (118 mL). The National Drug Code (NDC) for this product is 0363-0323-24. It is distributed by Walgreen Co., located at 200 Wilmont Rd., Deerfield, IL 60015. This product is comparable to Children's Tylenol® Oral Suspension.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It also provides relief from 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, it is advised to consult a doctor for the appropriate dose.

• For patients weighing 24-35 lb or aged 2-3 years, the recommended dose is 5 mL (1 teaspoon).

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL (1 ½ teaspoons).

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dose is 10 mL (2 teaspoons).

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL (2 ½ teaspoons).

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

If necessary, doses may be repeated every 4 hours while symptoms persist, but it is important not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Only the enclosed dosing cup, specifically designed for use with this product, should be utilized for measuring doses. The use of any other dosing device is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

Additionally, it is important to adhere to the recommended dosing guidelines to avoid the risk of overdose. If pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling occurs, discontinue use and seek medical advice, as these may indicate a serious condition.

Warnings and Precautions

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

Acetaminophen may also trigger severe skin reactions, which can 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.

Healthcare providers should be vigilant regarding the potential for severe sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions include advising caregivers to consult a physician prior to use if the child has a history of liver disease. Furthermore, it is essential to inquire about any concurrent use of blood-thinning medications, such as warfarin, and to seek guidance from a healthcare professional or pharmacist in such cases.

Caregivers should be instructed to discontinue use and contact a physician if the child experiences worsening pain lasting more than five days, a fever that worsens or persists beyond three days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. In cases of overdose, which may result from taking more than the recommended dose, immediate medical attention is critical, as liver damage can occur. Patients are advised to contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are present.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance immediately.

Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should stop using the product and consult a healthcare professional if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor before use if they have liver disease or if they are taking the blood-thinning medication warfarin.

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 Childrens Pain and Fever, Grape Flavor (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years, the recommended dosage is 5 mL (1 tsp); for those aged 4 to 5 years, 7.5 mL (1 1/2 tsp); for ages 6 to 8 years, 10 mL (2 tsp); for 9 to 10 years, 12.5 mL (2 1/2 tsp); and for 11 years, 15 mL (3 tsp).

Dosing should ideally be based on weight; if weight is not available, age may be used. Doses may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period. Use should not extend beyond 5 days unless directed by a healthcare professional.

Warnings include the risk of severe liver damage if more than 5 doses are taken in 24 hours or if combined with other medications containing acetaminophen. Parents should consult a doctor if the child has liver disease or is taking warfarin. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, medical advice should be sought promptly.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be obtained or a Poison Control Center contacted. Quick medical attention is crucial for pediatric patients, even if no symptoms are evident.

Geriatric Use

Elderly patients may not have specific information regarding the use of Children's Pain and Fever, Grape Flavor (acetaminophen suspension) as outlined in the drug insert. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Given the absence of dedicated studies or data on the geriatric population, it is advisable to monitor elderly patients closely for any potential adverse effects or changes in efficacy. Additionally, healthcare providers should consider individual patient factors, including comorbidities and concurrent medications, which may necessitate dosage adjustments or increased vigilance in this age group.

In the absence of specific recommendations, clinical judgment should guide the use of this medication in elderly patients, ensuring that the benefits outweigh any potential risks.

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. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of detailed information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are appropriately assessed.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 using this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to minimize the risk of severe liver damage.

Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver injury. Regular assessment of liver function is recommended to ensure patient safety and to detect any potential adverse effects related to hepatic impairment.

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.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with overdose and to ensure appropriate care is provided.

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 revealed that acetaminophen may be associated with severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, reports indicate that exceeding the recommended dosage of acetaminophen can lead to liver damage. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly, as timely medical intervention is essential for both adults and children, 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 nonprescription. 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. Healthcare providers should instruct patients to discontinue use and seek medical advice if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious 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 dose, 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. 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 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 recommended, as the product should not be exposed to lower temperatures. 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, Grape Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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