Childrens Pain and Fever

Description

SOUND BODY™ is an oral suspension formulated for the relief of children's pain and fever, containing acetaminophen as the active ingredient. Each 5 mL dose delivers 160 mg of acetaminophen. This product is alcohol-free, ibuprofen-free, and aspirin-free, making it suitable for children aged 2 to 11 years. The suspension is cherry-flavored and is packaged in a 4 FL OZ (118 mL) bottle. It is important to note that the product should not be used if the printed neckband is broken or missing. This formulation is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension. SOUND BODY™ is manufactured by AptaPharma Inc., located at 1533 Union Ave, Pennsauken, NJ 08110.

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, utilizing the dosage chart provided below. If weight is not available, age may be used as a secondary reference for dosing.

Dosing may be repeated every 4 hours as needed while symptoms persist; however, it is imperative not to exceed 5 doses within a 24-hour period. Continuous use beyond 5 days should only occur under the guidance of a physician.

Dosage Chart:

• For patients weighing under 24 lb (under 2 years): Consult a doctor.

• For patients weighing 24-35 lb (2 - 3 years): Administer 5 mL (1 teaspoon).

• For patients weighing 36-47 lb (4 - 5 years): Administer 7.5 mL (1 1/2 teaspoons).

• For patients weighing 48-59 lb (6 - 8 years): Administer 10 mL (2 teaspoons).

• For patients weighing 60-71 lb (9 - 10 years): Administer 12.5 mL (2 1/2 teaspoons).

• For patients weighing 72-95 lb (11 years): Administer 15 mL (3 teaspoons).

• *Or as directed by a doctor.

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 formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children 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. Healthcare professionals should advise parents and caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by symptoms such as fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Healthcare providers should inquire about any pre-existing liver disease in pediatric patients prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant, as potential interactions may necessitate careful monitoring.

Parents and caregivers should be instructed to discontinue use and seek medical advice if the child experiences worsening pain that lasts longer than 5 days, a fever that persists or worsens beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may be indicative of a serious medical condition requiring intervention.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. In cases of overdose, which may lead to liver damage, it is imperative for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, if pain worsens or lasts longer than five days, if fever intensifies or continues beyond three days, if new symptoms arise, or if there is any redness or swelling, patients should discontinue use and seek medical advice, as these may indicate a serious condition.

It is recommended that patients with a history of liver disease consult a healthcare provider prior to use. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this medication.

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 necessitates careful monitoring of all medications being taken. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 to 11 years, the recommended dosing is as follows:

• 2 - 3 years (24-35 lb): 5 mL (1 tsp)

• 4 - 5 years (36-47 lb): 7.5 mL (1 1/2 tsp)

• 6 - 8 years (48-59 lb): 10 mL (2 tsp)

• 9 - 10 years (60-71 lb): 12.5 mL (2 1/2 tsp)

• 11 years (72-95 lb): 15 mL (3 tsp)

The maximum daily amount should not exceed 5 doses within a 24-hour period. The duration of use should not exceed 5 days unless directed by a healthcare professional.

Caution is advised due to the potential for severe liver damage if the child exceeds the recommended dose or concurrently uses other medications containing acetaminophen. Consultation with a doctor is recommended if the child has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if new symptoms arise, including redness or swelling.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is indicated for use in children aged 2 to 11 years, and there are no documented dosage adjustments or safety concerns specifically related to elderly patients.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, given the lack of established guidelines for use in individuals aged 65 and older.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of acetaminophen during pregnancy. There are no specific dosage modifications for pregnant individuals; however, it is essential to seek guidance from a healthcare provider regarding appropriate use. Special precautions should be taken, and discussions with a healthcare provider are recommended to ensure the safety of both the patient and the fetus.

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 specific information available 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 this patient population.

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 when administering this product in conjunction with other medications that also contain 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.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose and the potential for significant health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay, utilizing the national hotline at 1-800-222-1222. Prompt intervention is crucial, as quick medical attention can be critical 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 risk of severe complications associated with liver damage.

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 compound in these areas.

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. Instances of allergic reactions, including anaphylaxis, have also been documented following the administration of acetaminophen. Furthermore, there have been reports of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing kidney conditions.

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 the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor 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 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 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 various package configurations, with specific NDC numbers available for identification. 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. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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