Pain and Fever

Description

Acetaminophen is presented in a liquid dosage form, containing 160 mg of acetaminophen per 5 mL. The formulation is flavored with grape and is free from ibuprofen and aspirin. Additionally, it is alcohol-free and paraben-free, ensuring a safer profile for use. The product is packaged in a 2 fluid ounce (59 mL) container and is intended for administration exclusively with the enclosed syringe.

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 pediatric use only and does not contain complete directions or warnings for adult administration. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided, with weight being the preferred method for dosing; if weight is unavailable, age may be used as an alternative.

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

1. Push air out of the enclosed syringe.

2. Insert the syringe tip into the bottle opening.

3. Flip the bottle upside down and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

4. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

It is crucial to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for this product should be used for dosing; no other devices are acceptable.

The dosing chart is as follows:

• For children weighing under 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

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

*Dosing may also be as directed by a healthcare professional.

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 administered to children who have a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

Warnings and Precautions

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

Acetaminophen has been associated with 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 that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen.

Patients may also experience severe skin reactions, which can 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.

Additionally, patients should be advised to consult a healthcare professional if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

It is crucial for patients to stop use and seek medical advice if new symptoms arise, if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, or if redness or swelling occurs, as these may indicate a serious condition.

Patients should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Those with a history of allergic reactions to this product or any of its ingredients should avoid its use. Furthermore, it is advisable for patients with liver disease or those taking the anticoagulant warfarin to consult a healthcare provider prior to use.

In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is critical.

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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional for dosing recommendations. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 5 mL. It is important to use only the enclosed syringe specifically designed for this product and to avoid using any other dosing device. Care should be taken not to exceed the recommended dosage, as an overdose may occur. When determining the appropriate dose, weight should be used whenever possible; if weight is not available, age may be used as a guide.

Geriatric Use

Elderly patients may not receive specific directions or complete warnings for adult use with this product. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect drug metabolism and response in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary based on individual patient needs and responses. Given the lack of comprehensive guidance for adult use, careful evaluation and clinical judgment are paramount when treating geriatric patients with this product.

Pregnancy

There are no specific statements regarding the use of acetaminophen suspension during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the absence of data when advising pregnant patients. It is recommended that the potential benefits and risks be carefully weighed before prescribing this medication to women of childbearing potential.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

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 lack of data 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 use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals adhere to the recommended dosing guidelines, as exceeding the recommended dose can lead to serious health consequences.

Immediate medical assistance should be sought in cases of suspected overdose. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical attention is crucial, even if the patient does not exhibit any immediate signs or symptoms of overdose.

It is essential to monitor the patient closely and provide supportive care as necessary while awaiting further medical intervention.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 about the importance of seeking immediate medical attention in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222, as prompt medical intervention is crucial, even if no signs or symptoms are apparent.

It is essential to instruct 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 their medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, they should be advised to discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, or if any redness or swelling occurs, as these may indicate a serious condition.

Healthcare providers should also recommend that patients seek medical advice before using this product if their child has liver disease. Furthermore, it is important to advise patients to consult with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

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 advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if any redness or swelling occurs.

Drug Information (PDF)

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

View product document (PDF)