Childrens Plus Flu

Description

This oral suspension contains acetaminophen, a pain reliever and fever reducer; chlorpheniramine maleate, an antihistamine; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. The formulation is designed to relieve symptoms associated with coughs, runny nose, sneezing, fever, sore throat, and stuffy nose. The product is presented in a grape flavor.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, sore throat, cough, sneezing, runny nose, headache, and stuffy nose. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

This product is intended for use in specific pediatric populations and does not contain directions or complete warnings for adult use. Prior to administration, the product must be shaken well. Dosing should only be measured using the dosing cup provided; the use of any other dosing device is not recommended. The dosing cup should be kept with the product at all times.

For pediatric patients aged 6 to 11 years, weighing between 48 to 95 pounds, the recommended dose is 10 mL. For children aged 4 to 5 years, weighing between 36 to 47 pounds, the product should not be used unless directed by a healthcare professional. For children under 4 years of age and those weighing less than 36 pounds, the product is contraindicated and should not be used.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is important not to exceed a total of 5 doses within a 24-hour period. If possible, dosing should be based on the child's weight; otherwise, age may be used as a guide.

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 children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are used for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is uncertainty about the child's prescription, a healthcare professional should be consulted.

• In children with a known allergy to acetaminophen or any inactive ingredients present in this product.

Additionally, this product should not be used to induce sleep in children, and the recommended dosage should not be exceeded to avoid the risk of overdose.

Warnings and Precautions

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.

This product contains acetaminophen, and caution is warranted due to the risk of severe liver damage. Such damage may occur if a child exceeds five doses within a 24-hour period, which is the maximum recommended daily amount, or if acetaminophen is taken concurrently with other medications containing acetaminophen.

Healthcare professionals should be vigilant 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, prompt consultation with a physician is advised.

Patients should be instructed to stop use and consult a healthcare provider if any of the following occur: new symptoms arise, redness or swelling is observed, pain, nasal congestion, or cough worsens or persists beyond five days, fever intensifies or lasts more than three days, or if nervousness, dizziness, or sleeplessness develops. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, medical evaluation is necessary, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as rapid intervention is essential.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can vary in seriousness and frequency.

Severe skin reactions have been reported, particularly in individuals with allergies to acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage associated with acetaminophen, especially if the maximum daily dosage of five doses within 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen. In cases of overdose, which can lead to liver damage, it is crucial to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Patients may also experience excitability, particularly in children, as well as marked drowsiness. The use of sedatives and tranquilizers may exacerbate drowsiness.

It is important for patients to monitor for new symptoms and to consult a healthcare provider if any of the following occur: redness or swelling, worsening pain, nasal congestion, or cough lasting more than five days, fever lasting more than three days, nervousness, dizziness, or sleeplessness. Additionally, if a cough recurs or is accompanied by a rash or headache that persists, medical advice should be sought promptly.

In the event of a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor immediately.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

In pediatric patients, this medication should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it is advised to avoid use for at least 2 weeks following the discontinuation of an MAOI to prevent serious interactions.

Healthcare professionals should be consulted prior to use if the child is concurrently taking sedatives or tranquilizers, as this may enhance sedative effects and lead to increased risk of respiratory depression.

Furthermore, it is recommended to seek advice from a healthcare provider if the child is on warfarin, a blood-thinning medication, due to the potential for altered anticoagulant effects and increased risk of bleeding. Monitoring of coagulation parameters may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Plus Flu (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 11 years are recommended to receive a dose of 10 mL. For children aged 4 to 5 years, use is not advised unless directed by a healthcare professional. The medication is contraindicated in children under 4 years of age.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness has been reported. It is crucial to adhere to the recommended dosing guidelines, which stipulate a maximum of 5 doses within a 24-hour period.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is necessary. The product should be kept out of reach of children to prevent accidental ingestion.

An overdose warning is applicable; exceeding the recommended dose may lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are present.

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

Pregnancy

Safety during pregnancy has not been established for this medication. While specific contraindications are not mentioned, caution is advised due to the limited studies on its effects on the fetus. There are no specific dosage modifications recommended for pregnant individuals. Healthcare professionals should counsel pregnant patients or those planning to become pregnant to consult a doctor before using this medication, as the potential risks to fetal outcomes are not well understood.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of this product on a nursing infant are not known.

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 be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur 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.

It is essential for patients with liver disease to consult a healthcare professional before using this product. In cases of overdose, which may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

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 remain vigilant regarding the signs and symptoms associated with overdosage, as these may not always be immediately apparent.

Immediate medical assistance is crucial in cases of suspected overdose. Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is essential, even in the absence of noticeable symptoms, to mitigate the risk of serious complications.

In summary, the management of overdose situations requires swift action and a thorough understanding of the potential risks involved, particularly concerning liver health.

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

No specific postmarketing experience details are provided in the insert.

Patient Counseling

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

Patients should be informed that this product is not intended to induce sleepiness in children and should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult a doctor or pharmacist.

It is critical to avoid using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with a healthcare professional if they are unsure whether their child's prescription includes an MAOI. Additionally, this product should not be administered to children with known allergies to acetaminophen or any inactive ingredients contained in the formulation.

Patients should be instructed to discontinue use and consult a doctor if new symptoms arise, or if there is any redness or swelling. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond five days, or if fever intensifies or lasts more than three days. Symptoms such as nervousness, dizziness, or sleeplessness warrant immediate consultation with a healthcare provider, as do recurring coughs accompanied by rash or headache.

While using this product, patients should be cautioned against exceeding the recommended dose due to the overdose risk. They should be made aware that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. The use of sedatives or tranquilizers may further enhance drowsiness, and patients should be advised to consult a doctor before use if their child has any of the following conditions: liver disease, glaucoma, thyroid disease, diabetes, heart disease, high blood pressure, or breathing problems such as chronic bronchitis.

Furthermore, patients should be encouraged to seek medical advice if their child has a cough associated with excessive phlegm or a persistent cough, such as that seen in asthma. Lastly, it is important to remind patients to consult a doctor or pharmacist if their child is taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that requires careful handling and storage to maintain its integrity and effectiveness. It should be stored at a temperature range of 20-25ºC (68-77°F) and must not be refrigerated. Prior to use, the product should be shaken well to ensure proper mixing.

It is essential to keep the dosing cup with the product for accurate measurement. Once opened, the product should be discarded to prevent any potential contamination. The packaging is designed to be tamper evident; therefore, it should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing.

Additional Clinical Information

The medication is administered orally and should not be used with any other dosing device. Clinicians should advise patients not to exceed five doses within a 24-hour period and to repeat doses every four hours as needed while symptoms persist.

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 or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

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

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