Childrens Pain Relief and Fever Reducer Oral Suspension Cherry

Description

Acetaminophen is the active ingredient in this formulation. The dosage form is an oral suspension with a strength of 160 mg per 5 mL. The product is flavored with cherry and is available in a volume of 4 FL OZ (118 mL).

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. The appropriate dose should be determined using the dosing chart provided below. When possible, weight should be used to calculate the dose; if weight is not available, age may be used as an alternative.

Dosing may be repeated every 4 hours as needed while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period. Additionally, the product should not be administered for more than 5 consecutive days unless directed by a healthcare professional.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age, 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 tsp).

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL (1 1/2 tsp).

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

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL (2 1/2 tsp).

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

It is essential to use only the enclosed dosing cup specifically designed for this product. The use of any other dosing device is not recommended.

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 dosage while using this product is contraindicated, as it may result in overdose and associated complications.

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 monitor for signs of liver impairment and educate caregivers on the importance of adhering to dosing guidelines.

Acetaminophen has been associated with severe skin reactions, which may 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 in assessing patients for these symptoms and advising caregivers accordingly.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended. This may indicate a more serious underlying condition that requires further evaluation.

Patients should be advised to stop taking the medication and contact their healthcare provider if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may be indicative of a serious condition.

Before initiating treatment, it is essential to consult a physician if the child has a history of liver disease. Additionally, healthcare professionals should inquire about the use of anticoagulants, specifically warfarin, as concurrent use may necessitate closer monitoring and potential adjustments in therapy.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the signs of liver damage and the importance of adhering to recommended dosages.

Additionally, there is an allergy alert indicating that acetaminophen may lead to severe skin reactions. Symptoms of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients should discontinue use immediately and seek medical assistance.

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.

In cases of overdose, which may result in liver damage, it is critical for patients to seek medical help or contact a Poison Control Center immediately, regardless of the presence of symptoms. Quick medical attention is essential for both adults and children.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Before using this product, patients should consult a healthcare provider if they have liver disease or if they are taking the anticoagulant medication warfarin, as interactions may occur.

Drug Interactions

Acetaminophen may interact with anticoagulants, particularly warfarin. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using acetaminophen if they are concurrently taking warfarin. This precaution is necessary to ensure safe and effective use, as the combination may alter the anticoagulant effect.

No additional drug interactions or laboratory test interactions have been identified for acetaminophen. Therefore, routine monitoring or dosage adjustments are not indicated beyond the aforementioned consideration with anticoagulants.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Pain Relief and Fever Reducer Oral Suspension Cherry (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 lb (under 2 years) should consult a doctor before use. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 5 mL (1 tsp). Patients weighing 36-47 lb (ages 4-5 years) should receive 7.5 mL (1 1/2 tsp), while those weighing 48-59 lb (ages 6-8 years) should be given 10 mL (2 tsp). For patients weighing 60-71 lb (ages 9-10 years), the dose is 12.5 mL (2 1/2 tsp), and for those weighing 72-95 lb (ages 11 years), the recommended dose is 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 used concurrently with other acetaminophen-containing medications. There is also an allergy alert for potential severe skin reactions, which may manifest as skin reddening, blisters, or rash; in such cases, use should be discontinued, and medical assistance sought immediately. Additionally, 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.

Consultation with a healthcare provider is advised if the pediatric patient has liver disease or is taking the anticoagulant warfarin. An overdose may lead to liver damage; in the event of an overdose, immediate medical attention or contact with a Poison Control Center is essential, 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no explicit statements concerning contraindications or risks to the fetus. Additionally, no dosage modifications for pregnant individuals are indicated, and the insert does not mention any special precautions regarding use during pregnancy. Healthcare professionals should consider the lack of information when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily amount of 5 doses within a 24-hour period or if they concurrently use other medications containing acetaminophen.

Due to the potential for increased risk of hepatotoxicity, healthcare providers should assess liver function prior to initiating treatment and consider dosage adjustments as necessary. Regular monitoring of liver function tests may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In cases of overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that individuals seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Healthcare professionals should be aware that early recognition and management of overdose can mitigate the risk of severe complications. Monitoring liver function and providing supportive care are essential components of the management strategy. It is recommended that healthcare providers remain vigilant and proactive in addressing any suspected overdose situations to ensure optimal patient 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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 made aware of the potential for allergic reactions. They must be informed to discontinue use and seek medical advice if their child is allergic to acetaminophen or any of the inactive ingredients in the product. Additionally, healthcare providers should instruct patients to stop using the medication and consult a doctor if pain worsens or persists for more than five days, if fever increases or lasts more than three days, if new symptoms arise, or if there is any 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. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a carton that contains essential information for proper use. It is important to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may affect the product's integrity. 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 Relief and Fever Reducer Oral Suspension Cherry, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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