Dye Free Childrens Acetaminophen

Description

Children's Acetaminophen Oral Suspension is formulated to provide effective pain relief and fever reduction. Each 5 mL dose contains 160 mg of acetaminophen. The product is dye-free and features a grape flavor, making it suitable for pediatric use. It is free from ibuprofen, alcohol, and aspirin, ensuring a safer option for children. The suspension is packaged in a non-child-resistant container and is supplied in a 5 mL dosage form. The National Drug Code (NDC) for this product is 0121-0966-05. Users are advised to shake well before using. This product is manufactured by Pharmaceutical Associates, Inc.

Uses and Indications

This drug is indicated for the 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

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosing chart to determine the appropriate dosage based on the patient's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

For dosing, the following guidelines should be adhered to:

• For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician for appropriate dosing.

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

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

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

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

• For patients weighing between 72-95 pounds (11 years), the recommended dose is 15 mL.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. For Single-Dose Cups, the entire contents should be consumed.

Healthcare professionals should ensure that patients do not exceed the recommended dosage and should be aware of the overdose warning associated with this product.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, 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 dose while using this product is contraindicated; adherence to dosing guidelines is essential to avoid overdose risks.

Warnings and Precautions

Severe liver damage may occur in pediatric patients 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. Healthcare professionals should monitor for signs of liver impairment in children receiving this medication.

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 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if the child experiences worsening pain lasting more than 5 days, fever that worsens or persists beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

Prior to administration, it is essential to inquire about any existing liver disease in the child. Additionally, consultation with a healthcare provider or pharmacist is recommended if the child is currently taking the anticoagulant warfarin, as potential interactions may necessitate further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product in conjunction with other medications containing acetaminophen. It is crucial for patients to adhere to the recommended dosage to mitigate the risk of liver injury.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they 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 persists for more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Furthermore, it is important for patients to consult a healthcare provider before using this product if they have liver disease or if they are taking the blood-thinning medication warfarin, as these factors may influence the safety and efficacy of the treatment.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. 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 Dye Free Childrens Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lb, the recommended dose is 5 mL. For those aged 4 to 5 years weighing 36-47 lb, the dose increases to 7.5 mL. Children aged 6 to 8 years weighing 48-59 lb should receive 10 mL, while those aged 9 to 10 years weighing 60-71 lb may take 12.5 mL. For children aged 11 years weighing 72-95 lb, the dose is 15 mL.

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 any skin reaction occurs, use should be discontinued immediately, and medical help should be sought.

Parents and caregivers should be aware of a sore throat warning; 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. The product should not be used in children who are allergic to acetaminophen or any of its inactive ingredients. Additionally, a doctor should be consulted before use if the child has liver disease or is taking the blood-thinning medication warfarin.

In the event of an overdose, immediate medical attention is critical. Parents and caregivers should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are present.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The prescribing information does not provide any safety concerns, dosage modifications, or special precautions related to the use of this product in pregnant patients. Additionally, there are no contraindications mentioned for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided in the current data.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 5 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications that contain acetaminophen to prevent the risk of hepatotoxicity.

Healthcare providers should assess liver function prior to initiating treatment and consider regular monitoring of liver enzymes during therapy, particularly in patients with known liver conditions. Adjustments to the dosing regimen may be necessary based on the severity of hepatic impairment, and caution is advised in this patient population to mitigate the risk of adverse effects related to liver function.

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 medical 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 care as directed by medical personnel.

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 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 non-prescription. 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 any of the following occur: pain worsens or persists for more than 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if there is any redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

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. 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, to avoid potential interactions.

Storage and Handling

The product is supplied in a package that is not child-resistant. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Prior to use, it is essential to shake the product well to ensure proper mixing and efficacy.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Quick medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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