Childrens Multi Symptom Fever and Cold

Description

NDC 30142-988-04 is a liquid formulation designed for the relief of cold and flu symptoms in children aged 6 to 11 years. This product contains a combination of active ingredients: 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 presented in a 4 FL OZ (118 mL) dosage form and is flavored with grape, incorporating both natural and artificial flavoring agents. The product is intended to alleviate symptoms such as fever, runny and stuffy nose, aches and pains, sore throat, and cough.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, including headache, minor sore throat pain, and cough due to minor throat and bronchial irritation associated with a cold. It also alleviates symptoms such as runny nose, sneezing, itchy nose or throat, and itchy, watery eyes due to hay fever. Additionally, this drug is effective in reducing nasal and sinus congestion and temporarily lowers fever.

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

Dosage and Administration

This product is intended for use in children aged 6 years and older. For children aged 6 to under 12 years, the recommended dose is 10 mL. Administration may occur every 4 hours as needed while symptoms persist; however, it is imperative not to exceed 5 doses within a 24-hour period unless specifically directed by a healthcare professional.

Prior to administration, the product must be shaken well to ensure proper mixing. It is essential to utilize the enclosed dosing cup exclusively for measuring the dose, as other dosing devices may lead to inaccurate dosing.

For children under 4 years of age, the use of this product is contraindicated. For children aged 4 to under 6 years, use is not recommended unless directed by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 4 years of age.

• In children with a known allergy to acetaminophen.

• In conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If uncertain about the presence of acetaminophen in a medication, consult a healthcare professional.

• In children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. If there is uncertainty regarding the presence of an MAOI in a child's prescription, seek advice from a healthcare professional.

• For the purpose of inducing sleepiness in children.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications containing acetaminophen.

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 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 before recommending this product, particularly if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or respiratory issues such as chronic bronchitis. Additionally, a doctor should be consulted if the child has a cough that produces excessive phlegm or a chronic cough, such as that associated with asthma.

It is also essential to consult a doctor or pharmacist prior to use if the child is currently taking sedatives, tranquilizers, or the anticoagulant warfarin.

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.

Discontinuation of the product and consultation with a healthcare provider is warranted if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond five days, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a recurrence of cough accompanied by rash or headache that lasts may indicate a serious condition and necessitate immediate medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is five doses within a 24-hour period, or who take this product concurrently with other medications containing acetaminophen.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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, it is recommended that they consult a healthcare professional promptly.

Common adverse reactions that may necessitate discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Patients should also seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than five days, if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs or occurs alongside a rash or headache lasting for an extended period. These symptoms could indicate a serious underlying condition.

Additional adverse reactions noted include marked drowsiness, which may be exacerbated by the use of sedatives and tranquilizers. In some cases, excitability has been reported, particularly in children.

Drug Interactions

Co-administration 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, the use of this medication is contraindicated in those who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease, and their interaction with this medication may lead to serious adverse effects.

Healthcare professionals should be consulted prior to the use of this medication in children who are receiving sedatives or tranquilizers, as these agents may potentiate drowsiness and other central nervous system effects.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. It is recommended that healthcare providers be consulted to assess the need for monitoring or dosage adjustments in patients taking warfarin to mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Multi Symptom Fever and Cold (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 to under 6 years, use is not recommended unless directed by a healthcare professional. In children aged 6 to under 12 years, the recommended dosage is 10 mL, with administration every 4 hours as needed while symptoms persist. It is important not to exceed the recommended dosage of 10 mL or more than 5 doses in a 24-hour period unless advised by a doctor.

Marked drowsiness may occur with use, and the concomitant use of sedatives or tranquilizers may enhance this effect. Additionally, excitability may be observed, particularly in younger children. If symptoms such as nervousness, dizziness, or sleeplessness arise, the use of the medication should be discontinued, and a healthcare provider should be consulted.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects and therapeutic responses is advised, as elderly patients may respond differently to medications compared to younger populations.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider prior to use. While potential risks to the fetus are not specified, caution is advised. There are no specific dosage modifications for pregnant individuals. It is recommended that women of childbearing potential discuss the use of this product with their healthcare provider to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed 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 there is a history of liver disease. It is essential to assess liver function to determine the appropriateness of treatment and any necessary dosage adjustments. Monitoring of liver function may be required to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Timely intervention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that prompt medical attention can significantly impact the outcome of an overdose situation.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate any adverse effects.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, emphasizing that prompt medical attention is critical even if no signs or symptoms are present.

It is important to inform patients that this product should not be used in children under 4 years of age. Additionally, patients should be cautioned against using this medication if their child is allergic to acetaminophen or if they are taking any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult a doctor or pharmacist.

Patients should also be made aware that this product is contraindicated for children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If there is any doubt about whether a child’s prescription includes an MAOI, patients should be advised to seek clarification from a healthcare professional.

Healthcare providers should stress that this medication is not intended for the purpose of inducing sleepiness in children. Patients should be instructed to discontinue use and consult a doctor if symptoms such as nervousness, dizziness, or sleeplessness occur. Furthermore, they should be advised to stop use and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, or if any redness or swelling is observed. New symptoms or a recurrence of cough, especially if accompanied by a rash or headache that lasts, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. They should be informed that marked drowsiness may occur and that the use of sedatives or tranquilizers may enhance this effect. Additionally, patients should be made aware that excitability may occur, particularly in children.

Healthcare providers should encourage patients to consult a doctor before use if the child has any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or any breathing problems such as chronic bronchitis. Patients should also be advised to seek medical advice if the child has a cough that produces excessive phlegm or if there is a chronic cough, such as that associated with asthma. Lastly, patients should be reminded to consult a doctor or pharmacist if the child is taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the inner seal under the cap; do not use the product if the seal is torn or missing.

For optimal storage, the product should be kept at room temperature and protected from light. It is important to ensure that the cap is closed tightly to maintain the integrity of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally and may be taken every 4 hours as needed, with a maximum of 5 doses in a 24-hour period unless otherwise directed by a healthcare provider.

Clinicians should counsel patients 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 Childrens Multi Symptom Fever and Cold, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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