Childrens Pain and Fever

Description

AP SAFE® is an acetaminophen oral suspension formulated for the relief of pain and reduction of fever in children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen. The product is presented in a 4 FL OZ (118 mL) bottle and features a grape flavor. It is alcohol-free, ibuprofen-free, and aspirin-free. The National Drug Code (NDC) for this product is 76821-526-24.

This formulation is not manufactured or distributed by McNeil Consumer Healthcare, the distributor of Children's Tylenol® Oral Suspension. It is produced by AptaPharma Inc., located at 1533 Union Ave., Pennsauken, NJ 08110. Users are advised not to use the product if the printed neck band is broken or missing.

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. For both Children's Pain & Fever and Infants' Pain Relief, healthcare professionals should refer to the appropriate dosage chart to determine the correct dose based on the child's weight. If weight is not available, age may be used as a secondary guide.

For Children's Pain & Fever, the following dosing guidelines apply:

• For children weighing under 24 lb or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

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

• For children weighing 36-47 lb (4-5 years), the recommended dose is 7.5 mL (1.5 teaspoons).

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

• For children weighing 60-71 lb (9-10 years), the recommended dose is 12.5 mL (2.5 teaspoons).

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

• Dosing may also be as directed by a doctor.

For Infants' Pain Relief, the dosing guidelines are as follows:

• For infants weighing under 24 lb or under 2 years of age, it is advised to consult a doctor for the appropriate dose.

• For infants weighing 24-35 lb (2-3 years), the recommended dose is 5 mL.

• Dosing may also be as directed by a doctor.

In both cases, if needed, doses may be repeated every 4 hours while symptoms persist, but no more than 5 doses should be administered in a 24-hour period. Treatment should not exceed 5 days unless directed by a healthcare professional.

It is essential to use only the enclosed dosing cup for Children's Pain & Fever and the enclosed dosing syringe for Infants' Pain Relief, as these devices are specifically designed for use with this product. Other dosing devices should not be used.

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 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.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage while using this product is contraindicated, as it may lead to serious adverse effects.

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 also contain acetaminophen.

Acetaminophen has been 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, it is essential to consult a healthcare professional without delay.

Healthcare professionals should advise patients to discontinue use and contact a physician if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or lasts longer than 3 days, new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Emergency medical help should be sought immediately if a skin reaction occurs after taking this product.

General precautions include advising caregivers to consult a physician prior to use if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a healthcare provider or pharmacist before administering this product to a child who is currently taking the anticoagulant medication warfarin.

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 is exceeded, specifically if more than five doses are taken within a 24-hour period or if the product is used concurrently with other medications containing acetaminophen. In cases of overdose, which may also lead to liver damage, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, it is imperative to discontinue use and seek medical help without delay.

In addition, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Before using this product, it is recommended that patients consult a doctor if they have liver disease. Furthermore, patients taking the blood-thinning medication 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 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 (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 should be given 12.5 mL (2 1/2 tsp). For adolescents aged 11 years and weighing 72-95 lb, 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, but should not exceed 5 doses in a 24-hour period or be administered for more than 5 consecutive days without a doctor's direction.

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 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.

Consultation with a healthcare provider is advised if the child has liver disease or is taking warfarin, a blood-thinning medication. 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 Children's Pain and Fever (acetaminophen suspension) as outlined in the drug insert. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the lack of targeted 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, consideration should be given to the possibility of altered pharmacokinetics in this age group, which may necessitate dosage adjustments based on individual patient factors such as renal function and overall health status.

In the absence of specific guidelines, healthcare providers are encouraged to apply clinical judgment and standard practices when treating elderly patients with this medication.

Pregnancy

Pregnant patients should be advised against the use of this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. It is essential for healthcare providers to assess the patient's medical history, particularly regarding liver disease, as the use of this product may pose risks in such cases. Additionally, caution is warranted if the patient is concurrently taking warfarin, a blood-thinning medication, as interactions may occur.

The product should not be administered for more than 5 days unless specifically directed by a healthcare professional. This precaution is crucial to minimize potential adverse effects on both the mother and the developing fetus. Healthcare providers are encouraged to weigh the benefits against the risks when considering this product for pregnant patients.

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 when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 the maximum daily amount of more than 5 doses in 24 hours is exceeded, or if the product is taken concurrently with 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

In the event of an overdose, it is crucial to recognize that exceeding the recommended dosage may lead to significant liver damage. Healthcare professionals should be aware that prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Recommended Actions In cases of suspected overdose, immediate medical assistance should be sought. It is advisable to contact a Poison Control Center without delay; the national hotline can be reached at 1-800-222-1222. This step is vital to ensure appropriate management and treatment.

Potential Symptoms While specific symptoms of overdose may not always be evident, the risk of liver damage underscores the importance of vigilance and proactive care. Healthcare providers should monitor patients closely and be prepared to initiate treatment protocols as necessary.

In summary, the management of overdose situations requires swift action and thorough assessment to mitigate potential harm, particularly concerning liver health.

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

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 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 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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