Infants Pain and Fever

Description

Acetaminophen is presented as an oral suspension containing 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer, featuring an organic cherry flavor for palatability. Each bottle includes a syringe for accurate dosing. The product is tamper evident, with a safety seal and a perforated band around the bottle; it should not be used if the bottle seal is disturbed or missing. Acetaminophen is distributed by KinderFarms®, located in Redondo Beach, CA 90277, USA, and further information can be found at kinderfarms.com.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as 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 healthcare professionals should ensure that the dosage is appropriate for the child's weight or age. Prior to administration, the product must be shaken well. The enclosed syringe is the only device recommended for dosing; other syringes, droppers, spoons, or dosing devices should not be used.

To administer the medication, the cap should be removed, and the syringe inserted into the hole at the top of the bottle until it snaps into place. The bottle should then be turned upside down. The healthcare professional should pull back the syringe until it is filled to the prescribed level. If the prescribed level is exceeded, the assembly should be inverted to the right side up on a flat surface, and the syringe should be pushed back to the desired level. The liquid should be dispensed slowly into the child's mouth, directed towards the inner cheek.

Dosing intervals are as follows: if needed, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses in a 24-hour period and not to administer the medication for more than 5 consecutive days unless directed by a physician.

For dosing, healthcare professionals should refer to the following dosage chart:

• 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.

After use, the cap should be replaced tightly to maintain child resistance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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 product, 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, if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise patients and caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

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 is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

Prior to administration, it is essential to inquire about the patient's medical history, particularly regarding liver disease. Additionally, caution is advised when this product is used in conjunction with the anticoagulant warfarin; consultation with a healthcare provider or pharmacist is recommended.

While using this product, it is critical not to exceed the recommended dosage. Patients should be advised to discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious underlying condition.

An overdose warning is pertinent, as exceeding the recommended dose can lead to liver damage. In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay, even if no signs or symptoms are apparent, as prompt intervention is crucial.

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 should also be alerted to the risk of 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.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients are advised to consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the blood-thinning medication warfarin should consult a healthcare provider or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dose. Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 5 days, or if fever worsens or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is essential to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 to 3 years are recommended to receive a dosage of 5 mL. For those under 2 years of age, it is advised to consult a healthcare professional to determine the appropriate dosage.

The product should not be administered more than five times within a 24-hour period and should not be used for more than five consecutive days unless directed by a physician. It is essential to use only the enclosed syringe for dosing; other syringes, droppers, spoons, or dosing devices should not be utilized when administering this medication to children.

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 well as to consider alternative therapies that may have more comprehensive labeling for elderly individuals.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

Nursing 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, as the effects on the nursing infant are not fully understood.

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 crucial to adhere to the recommended dosage, as exceeding this may lead to liver damage. Specifically, severe liver damage can occur if a patient takes more than five doses within a 24-hour period, which is the maximum daily allowance. Additionally, caution is advised when considering the use of acetaminophen in conjunction with other medications that also contain acetaminophen, as this combination may significantly increase the risk of severe liver damage. Regular monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate management procedures as necessary.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and timely intervention in cases of suspected overdose.

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 rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Healthcare providers should also instruct patients to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dose, reiterating the overdose warning. Additionally, healthcare providers should recommend that patients seek medical advice before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that is safety sealed with a tamper-evident perforated band. It is essential to inspect the bottle seal before use; do not use if the seal is disturbed or missing.

Storage conditions require the product to be maintained at a temperature between 20-25ºC (68º-77ºF). It is crucial to avoid refrigeration. To ensure child resistance, the cap should be replaced tightly after each use. Additionally, the outer carton should be retained for complete warnings and product information.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

Patients should be counseled to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are apparent.

Drug Information (PDF)

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

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