Childrens Pain and Fever

Description

AP SAFE® is an oral suspension formulation containing acetaminophen as the active ingredient, indicated for the relief of pain and reduction of fever. This product is alcohol-free, ibuprofen-free, and aspirin-free, making it suitable for pediatric use in children aged 2 to 11 years. Each 5 mL dose delivers a dosage strength of 160 mg of acetaminophen. The product is presented in a 4 FL OZ (118 mL) container and features a cherry flavor for palatability. AP SAFE® is manufactured by AptaPharma Inc., located at 1533 Union Ave., Pennsauken, NJ 08110. It is important to note that this product is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the 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

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 between 24-35 lb or aged 2 to 3 years, the recommended dose is 5 mL (1 teaspoon).

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

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

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

• For patients weighing between 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. However, 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:

• 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.

• Exceeding the recommended dosage while using this product is contraindicated, as it may lead to overdose and associated complications.

Warnings and Precautions

Severe liver damage may occur in pediatric patients 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 contain acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of hepatotoxicity.

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.

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 healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals 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 closer monitoring.

Patients should be instructed to discontinue use and contact a healthcare provider if pain worsens or persists beyond five days, if fever intensifies 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 requiring further evaluation.

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. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as 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 two 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 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 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 indicate a serious condition.

Before using this medication, it is recommended that patients with liver disease consult a healthcare provider. 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 is heightened when multiple sources of acetaminophen are used simultaneously. 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 (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). For adolescents aged 11 years and older weighing 72-95 lb, the recommended dose is 15 mL (3 tsp). Dosing may also be directed by a physician.

Severe liver damage may occur if a child takes more than 5 doses in 24 hours, which is the maximum daily amount, or if used concurrently with other medications containing acetaminophen. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if such reactions occur, use should be discontinued immediately, and medical assistance sought. 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.

Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. An overdose may lead to liver damage; in such cases, immediate medical help or contact with a Poison Control Center is essential, even if no symptoms are apparent.

It is important to use only the enclosed dosing cup specifically designed for this product and to avoid using any other dosing device.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus have not been fully evaluated; therefore, caution is advised when considering the use of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to guide pregnant patients regarding appropriate dosing. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional to weigh the benefits against any potential risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 liver toxicity, 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

Taking more than the recommended dose of this medication may lead to liver damage. It is crucial for healthcare professionals to be aware of the potential 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, utilizing the national hotline at 1-800-222-1222. Prompt intervention is essential, as quick medical attention can significantly impact outcomes 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.

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 insert does not provide any data on carcinogenicity or mutagenicity. Furthermore, there is no information related to the impairment of fertility in the context of nonclinical studies.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reports indicate that symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there have been warnings regarding the risks of overdose. Taking more than the recommended dose may lead to liver damage. In cases of suspected 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 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 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 dosage, including the potential for overdose. 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 should be stored at a temperature range of 20-25ºC (68-77ºF) and must not be refrigerated. It is important 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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