Dr. Sana Pain and Fever for Children

Description

The product is identified by the SPL code 34089-3. No additional relevant information is available regarding its characteristics or specifications.

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

The product should be administered orally, adhering strictly to the recommended dosage guidelines. Healthcare professionals are advised to determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a secondary reference.

The following dosage chart provides specific dosing recommendations:

• For patients weighing under 24 lb (under 2 years of age), the dose should be determined by consulting a physician.

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

• For patients weighing 36-47 lb (4-5 years of age), the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb (6-8 years of age), the recommended dose is 10 mL.

• For patients weighing 60-71 lb (9-10 years of age), the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb (11 years of age), the recommended dose is 15 mL.

Doses may be repeated every 4 hours as needed while symptoms persist; however, it is critical not to exceed 5 doses within a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Caution is advised when administering this product alongside other medications that also contain acetaminophen, as this may lead to unintentional overdose.

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 professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is advised. Additionally, this product should not be administered to children with known allergies to acetaminophen or any of the inactive ingredients.

Prior to use, it is essential to consult a healthcare provider if the child has a history of liver disease. Furthermore, consultation with a doctor or pharmacist is recommended if the child is currently taking the anticoagulant warfarin.

When using this product, it is crucial not to exceed the recommended dosage. Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of several 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. Patients with pre-existing liver disease should consult a doctor prior to use.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

It is important to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the contents of any other medications with a doctor or pharmacist if uncertain. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

While using this product, patients must adhere to the recommended dosage. They should discontinue use and seek medical advice 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 occurs, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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 may be heightened. 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 Dr. Sana Pain and Fever for Children (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not exceed the directed dosage of this product, which lacks comprehensive warnings for adult use. Dosing should ideally be based on weight; if weight is unavailable, age may be used. Doses may be repeated every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

The recommended dosing by weight and age is as follows:

• Under 24 lb / under 2 years: Consult a doctor

• 24-35 lb / 2-3 years: 5 mL

• 36-47 lb / 4-5 years: 7.5 mL

• 48-59 lb / 6-8 years: 10 mL

• 60-71 lb / 9-10 years: 12.5 mL

• 72-95 lb / 11 years: 15 mL

Caution is advised due to the presence of acetaminophen, as severe liver damage may occur if more than 5 doses are taken within 24 hours. This is the maximum daily amount. The product should not be used in children with known allergies to acetaminophen or any inactive ingredients. Consultation with a healthcare provider is recommended if the child has liver disease or is taking the anticoagulant warfarin.

It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Quick medical attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advisable, as elderly patients may have different pharmacokinetic and pharmacodynamic profiles compared to younger populations.

Pregnancy

There are no specific statements regarding the use of DR. SANA PAIN AND FEVER FOR CHILDREN - acetaminophen syrup during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this medication during pregnancy.

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

Patients with renal impairment have not been specifically addressed in terms of 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if there is a known history of liver disease. It is essential to assess liver function to determine the appropriateness of treatment and any necessary dosage adjustments. Monitoring of liver function tests may be required to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued and medical assistance sought immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to communicate the potential risks associated with overdose. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Emphasize that quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a temperature range of 20-25℃ (68-77˚F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the packaging prior to use; the product should not be utilized if the carton tape or bottle wrap is broken or missing, as this may compromise the safety and quality of the product. Proper handling and storage conditions are crucial to ensure optimal performance.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not exceeding 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor if the child has liver disease or is taking warfarin, a blood-thinning medication. Patients should be advised to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)