Pain and Fever

Description

Acetaminophen is an oral suspension formulated as a pain reliever and fever reducer, specifically indicated for children aged 2 to under 12 years. Each 1/2 teaspoon (2.5 mL) contains 80 mg of acetaminophen, equating to 160 mg per 5 mL. The product is alcohol-free, aspirin-free, and ibuprofen-free, and is presented in a cherry flavor. The total volume of the suspension is 4 FL.OZ. (120 mL), and it is identified by NDC 45014-131-04. This formulation is comparable to Children's Tylenol®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product must be shaken well before use. Dosing is determined by weight using the rotating bottle label; alternatively, healthcare professionals may refer to the age-based dosing chart provided below. The product is specifically designed for administration with the enclosed dosing spoon; only this spoon should be used to measure the dose.

For patients under 2 years of age, it is advised to consult a physician before administration. For children aged 2 to 3 years, the recommended dose is 5 mL (1 teaspoon). For those aged 4 to 5 years, the dose increases to 7.5 mL (1½ teaspoons). Children aged 6 to 8 years should receive 10 mL (2 teaspoons), while those aged 9 to 10 years should be given 12.5 mL (2½ teaspoons). For children aged 11 years, the appropriate dose is 15 mL (3 teaspoons).

Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated 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.

Exceeding the recommended dose is contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

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

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

Healthcare providers should instruct caregivers not to use this product alongside any other medications that contain acetaminophen, whether they are prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to consult a doctor or pharmacist for clarification.

Before administering this product, it is essential to inquire about the child's medical history, particularly regarding any existing liver disease. Furthermore, if the child is currently taking the anticoagulant warfarin, consultation with a healthcare professional is recommended prior to use.

While using this product, it is critical to adhere strictly to the recommended dosage. Caregivers should be advised to discontinue use and seek medical advice if the child experiences any of the following: worsening pain that lasts more than five days, a fever that worsens or persists beyond three days, the emergence of new symptoms, or any signs of redness or swelling. These may be indicative of a serious condition requiring further investigation.

In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Caregivers should contact a Poison Control Center (1-800-222-1222) without delay, as prompt medical attention is crucial, even if no symptoms are immediately apparent.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it concurrently with other medications containing acetaminophen. In cases of overdose, which may also lead to liver damage, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical, even if no signs or symptoms are present.

Patients should be advised to consult a physician if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, individuals should discontinue use and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor prior to use if they have liver disease or if they are taking the blood-thinning medication warfarin. Adherence to the recommended dosage is crucial to avoid adverse effects.

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. 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 under 2 years of age should consult a doctor before use. For children aged 2 to 3 years, the recommended dose is 5 mL (1 tsp), while those aged 4 to 5 years should receive 7.5 mL (1½ tsp). Children aged 6 to 8 years may take 10 mL (2 tsp), and those aged 9 to 10 years can be given 12.5 mL (2½ tsp). For children aged 11 years, the appropriate dose is 15 mL (3 tsp).

It is crucial not to exceed the recommended dose. Parents or caregivers should seek medical advice if the child has liver disease or is taking the blood-thinning medication warfarin.

A liver warning is in place, as severe liver damage may occur if a child takes more than 5 doses in 24 hours or if combined with other medications containing acetaminophen. An overdose, defined as taking more than the recommended dose, may also lead to liver damage. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of acetaminophen during pregnancy in the provided text. The insert does not mention any contraindications or risks associated with the use of this product during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The text also does not include any special precautions regarding the use of this product during pregnancy. As such, healthcare professionals should consider the absence of specific data when advising pregnant patients on the use of acetaminophen.

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 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 lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Before administering this product, it is advisable to consult a healthcare professional if the patient has a history of liver disease. In cases of overdose, which may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is critical, even in the absence of noticeable signs or symptoms of overdose.

Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects associated with acetaminophen use.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals recognize the seriousness of this situation and act promptly.

Immediate medical assistance is crucial. In cases of suspected overdose, healthcare providers should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Even in the absence of noticeable signs or symptoms, swift medical intervention is essential. The lack of immediate symptoms does not negate the risk of serious complications, particularly concerning liver function. Therefore, healthcare professionals should ensure that patients understand the importance of seeking help promptly in the event of an 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be instructed to stop using the medication and seek medical advice if they experience any of the following: worsening pain that lasts more than 5 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious condition.

Healthcare providers must emphasize the importance of not exceeding the recommended dose of the medication. Additionally, patients should be advised to consult a doctor before use if the child has liver disease. It is also crucial to recommend that patients speak with a doctor or pharmacist before using this medication if the child is currently taking the blood-thinning drug warfarin.

Storage and Handling

The product is supplied in a configuration that includes an inner foil seal, which must remain intact; do not use the product if the seal is broken or missing. It should be stored at a temperature range of 20°-25°C (68°-77°F) to ensure its stability and efficacy. For reference, the lot number and expiration date can be found on the bottom panel of the packaging.

Additional Clinical Information

Patients should be informed that 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. It is crucial to adhere to the recommended dosage and to 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 Pain and Fever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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