Dye Free Infants Pain and Fever

Description

No description information is available for the specified drug.

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

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well to ensure proper mixing.

Dosing should be determined using the provided dosing chart. When possible, weight should be used to calculate the appropriate dose; if weight is not available, age may be used as a substitute.

To prepare the dose, healthcare professionals should follow these steps:

1. Push the air out of the syringe before inserting the syringe tip into the bottle opening.

2. Invert the bottle and pull the yellow part of the syringe to the correct dose.

3. Administer the liquid slowly into the child’s mouth, directing it toward the inner cheek to facilitate swallowing.

The recommended dosing interval is every 4 hours as needed while symptoms persist. However, it is critical not to exceed 5 doses within a 24-hour period. After administration, ensure that the cap is replaced tightly to maintain child resistance.

It is imperative to use only the enclosed syringe specifically designed for this product. No other dosing devices should be utilized to avoid dosing errors. Additionally, this product does not contain directions or complete warnings for adult use, and care should be taken to adhere to the overdose warning by not exceeding the directed dosage.

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. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

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

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than 5 doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases where a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

General Precautions Prior to administration, it is advisable to consult a physician if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is essential for both adults and children, even in the absence of overt symptoms.

Discontinuation and Consultation Caregivers should be instructed to stop use and consult a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms arise, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of acetaminophen, which is more than 5 doses in a 24-hour period, or when used concurrently with 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 medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. It is advised that patients do not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a doctor or pharmacist.

Patients with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use. Additionally, it is recommended that patients with liver disease consult a doctor before using this product. Those taking the blood-thinning medication warfarin should also seek advice from a healthcare professional prior to use.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a doctor if pain worsens or persists beyond 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.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may lead to an increased risk of bleeding. Therefore, it is essential to monitor International Normalized Ratio (INR) levels closely in patients who are concurrently using these medications. Adjustments to the dosage of warfarin may be required based on INR results to maintain therapeutic efficacy while minimizing the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not be given this product without consulting a doctor. For children aged 2 to 3 years weighing between 24 to 35 lbs, the recommended dose is 1.5 mL.

Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Parents or caregivers should verify the presence of acetaminophen in other medications by consulting a doctor or pharmacist. It is contraindicated in children with a known allergy to acetaminophen or any inactive ingredients in this product.

Before administering this medication, it is advisable to consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin.

Caregivers should ensure that the correct dose is administered by referring to the dosing chart, ideally using the child's weight; otherwise, age may be used. The product should be shaken well before use, and only the enclosed syringe designed for this product should be utilized for dosing.

In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center is essential, as prompt medical attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the insert does not provide guidance on geriatric use. The product is primarily intended for infants and children, and there are no documented dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise caution when considering this product for elderly patients, given the absence of relevant clinical findings or recommendations. Monitoring for any potential adverse effects or interactions is advised, as the lack of data does not preclude the possibility of unique responses in this population.

Pregnancy

The prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. There are no explicit warnings or contraindications related to pregnancy mentioned in the available text. Additionally, no dosage modifications are specified for pregnant individuals, and no special precautions regarding the use of acetaminophen during pregnancy are included. Healthcare professionals should consider the absence of specific information and exercise clinical judgment when prescribing acetaminophen to pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The presence of acetaminophen in this formulation necessitates caution, as severe liver damage may occur if the patient exceeds five doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of liver damage is heightened when this product is used concurrently with other medications containing acetaminophen. Therefore, careful monitoring of liver function and adherence to dosing guidelines is essential to mitigate the risk of adverse effects in patients with compromised 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 observable 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 comprehensive 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 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 crucial 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 important to emphasize the necessity 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 various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Patients should be advised to discontinue use and seek immediate medical attention if a skin reaction occurs. Additionally, they should stop use and consult a doctor 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.

Drug Information (PDF)

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

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