Pain and Fever

Description

Acetaminophen oral suspension contains 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer. The product is dye-free and features a grape flavor. It is free from aspirin, ibuprofen, alcohol, parabens, and high fructose corn syrup. The suspension is packaged in a 2 FL OZ (59 mL) bottle and is intended for use with the enclosed syringe. For detailed usage instructions, refer to the side panel.

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 does not exceed the recommended limits, as indicated in 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 not available, age may be used as an alternative.

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

1. Push the air out of the 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 essential to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for use with this product should be utilized; no other dosing devices are permitted.

For specific dosing based on weight and age, refer to the following chart:

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

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

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

• The product should not be administered to children who have a history of allergic reactions to this product or any of its components.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the child exceeds five doses within a 24-hour period, the maximum daily amount, or if it is taken concurrently with other medications containing acetaminophen.

Acetaminophen may also lead to 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.

In cases of severe sore throat that persists for more than two 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 inquire about the child’s medical history, particularly regarding liver disease, before recommending this product. Additionally, it is essential to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if pain worsens or persists beyond 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.

Side Effects

Patients using this product should be aware of several important warnings and 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 liver disease should consult a doctor before use.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, 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, it is essential to consult a doctor promptly.

Patients should stop using the product 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 is observed, as these may indicate a serious condition.

Additionally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product. In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended, as prompt medical attention is critical even if no signs or symptoms are present.

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

Pediatric Use

Pediatric patients aged 2 to 3 years are recommended for use of this product. For children weighing under 24 lbs (under 2 years), consultation with a healthcare professional is advised prior to use. For those weighing between 24 and 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 secondary measure. It is important not to exceed 5 doses within a 24-hour period. Additionally, only the enclosed syringe specifically designed for this product should be utilized for accurate dosing.

Geriatric Use

Elderly patients may not receive adequate guidance regarding the use of this product, as it does not contain directions or complete warnings specifically for adult use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for inadequate information on safety and efficacy in this population. It is essential to monitor these patients closely and assess their individual needs, as the absence of tailored guidance may impact treatment outcomes.

Pregnancy

There is no specific information available regarding the use of acetaminophen suspension during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medication use with their healthcare provider during pregnancy.

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 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 use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential dosage adjustments 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 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

Acetaminophen has been associated with severe skin reactions in postmarketing experience. Reports indicate that symptoms may include skin reddening, blisters, and rash. In cases where a skin reaction occurs, 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 other 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, healthcare providers should emphasize the need to discontinue use and consult a doctor if the child's 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.

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, which should be referenced for accurate 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.

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 potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, 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, as these may indicate a serious condition.

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)