Dye Free Infants Pain and Fever

Description

The product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available data.

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 are advised to administer the medication according to the following guidelines. It is imperative to adhere to the prescribed dosage and not exceed the recommended limits.

Prior to administration, the bottle should be shaken well to ensure proper mixing of the contents. The appropriate dose can be determined using the dosing chart provided below. When possible, dosing should be based on the child's weight; if weight is not available, age may be used as a reference.

Dosing Chart:

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

• For children weighing between 24-35 lbs or aged 2-3 years, the recommended dose is 5 mL.

To prepare the dose, the healthcare professional 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.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses within a 24-hour period. After use, ensure that the cap is replaced tightly to maintain child resistance.

Only the enclosed syringe specifically designed for use with this product should be utilized for dosing. 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, as this may lead to severe allergic reactions.

• Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician without delay.

Emergency medical help should be sought in the event of an overdose. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should also advise patients to discontinue use and consult a doctor if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. These may be indicative of a serious underlying condition that requires 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.

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. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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 seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms develop, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires medical evaluation.

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 Dye Free Infants Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should consult a doctor before use. For children weighing 24-35 lbs (ages 2-3 years), the recommended dose is 5 mL. Dosing should be determined primarily by weight; if weight is not available, age may be used as a guide. The medication can be administered every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

Healthcare professionals should be aware of the potential for severe liver damage if more than 5 doses are taken within 24 hours. There is an allergy alert for acetaminophen, which may cause severe skin reactions; medical assistance should be sought if such symptoms occur. Additionally, it is advised to consult a doctor if the child has liver disease or is taking warfarin.

In the event of an overdose, immediate medical help should be sought, or a Poison Control Center should be contacted, as prompt medical attention is critical for pediatric patients.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 are not clearly defined, and caution is advised when considering the use of this medication during pregnancy.

Dosage adjustments may be necessary, and it is important for healthcare providers to evaluate the individual circumstances of each patient. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed 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 be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in patients with compromised liver function, may significantly increase the risk of hepatotoxicity.

Additionally, patients should be advised to avoid concomitant use of other medications containing acetaminophen to prevent cumulative dosing, which could further exacerbate the risk of liver injury. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy while using this product.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have inadvertently exceeded this dosage.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk for liver injury. It is essential to assess the patient's medication history to identify any potential interactions that could exacerbate the risk of hepatotoxicity.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management protocols, which may include supportive care and monitoring of liver function tests. Early intervention is crucial to mitigate the risk of long-term hepatic 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 absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which may manifest as symptoms including skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately and medical assistance sought.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to caution patients against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Patients should be instructed to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever worsens 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.

While using this product, patients must not exceed the recommended dose, as highlighted in the overdose warning. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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 discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies 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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