Childrens Plus Multi Symptom Cold

Description

This formulation contains acetaminophen, a pain reliever and fever reducer; chlorpheniramine maleate, an antihistamine; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. It is designed to relieve symptoms associated with aches, fever, sore throat, sneezing, cough, and both runny and stuffy nose. The product is presented as an oral suspension with a grape flavor, specifically indicated for use in children aged 6 to 11 years. A dosage cup is provided for accurate administration.

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, nasal congestion, 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 pediatric patients aged 4 years and older. Prior to administration, the product must be shaken well. The dosing should be measured exclusively with the dosing cup provided; the use of any other dosing device is not recommended. The dosing cup should be kept with the product for convenience.

For patients weighing between 48 to 95 pounds (ages 6 to 11 years), the recommended dose is 10 mL. For patients weighing between 36 to 47 pounds (ages 4 to 5 years), the product should not be used unless directed by a physician. For patients weighing less than 36 pounds or those under 4 years of age, the product is contraindicated.

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

Contraindications

Use of this product is contraindicated in the following situations:

• In children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, due to the potential for serious interactions. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised.

• Concurrent use with any other medication containing acetaminophen, whether prescription or over-the-counter, is contraindicated to prevent the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

• This product should not be administered to children with a known allergy to acetaminophen or any inactive ingredients contained in the formulation.

• The product is not intended for use to induce sleep in children.

• Exceeding the recommended dosage is contraindicated due to the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses (10 mL) within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should monitor patients for adherence to dosing guidelines to prevent potential hepatotoxicity.

Acetaminophen is associated with the risk of severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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 if it is accompanied or followed by additional symptoms such as fever, headache, rash, nausea, or vomiting, healthcare providers should be consulted without delay to rule out serious underlying conditions.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help, even if no signs or symptoms are apparent, as prompt intervention is essential.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the emergence of new symptoms, presence of redness or swelling, worsening pain, nasal congestion, or cough lasting more than 5 days, fever that worsens or persists beyond 3 days, or the onset of nervousness, dizziness, or sleeplessness. Additionally, if a cough recurs or is accompanied by a rash or headache that persists, these may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 5 doses (10 mL) within 24 hours or if they use it concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for 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.

Participants using this product may experience excitability, particularly in children, as well as marked drowsiness. The concomitant use of sedatives and tranquilizers may exacerbate drowsiness.

Patients are advised to stop use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, or if pain, nasal congestion, or cough worsens or persists beyond 5 days. Additionally, if fever worsens or lasts more than 3 days, or if symptoms such as nervousness, dizziness, or sleeplessness develop, medical advice should be sought. A return of cough or the occurrence of cough with rash or headache that lasts may indicate a serious condition requiring prompt evaluation.

In cases of overdose, which may result from taking more than the recommended dose, patients are at risk for liver damage. Immediate medical attention is crucial, and individuals should contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are apparent.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently 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 administration for a period of two weeks following the discontinuation of an MAOI.

In cases where the pediatric patient is receiving sedatives or tranquilizers, consultation with a healthcare professional, such as a doctor or pharmacist, is recommended prior to use.

Furthermore, if the child is on warfarin, a blood-thinning medication, it is essential to seek guidance from a healthcare provider before initiating treatment with this medication. Monitoring and potential dosage adjustments may be necessary based on the clinical scenario and the healthcare provider's assessment.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Plus Multi Symptom Cold (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride). 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, specifically for those weighing between 48 to 95 lbs. For children aged 4 to 5 years, use is not advised unless directed by a healthcare professional, particularly for those weighing 36 to 47 lbs. The product is contraindicated in children under 4 years of age, which includes those weighing less than 36 lbs.

It is important to note that the maximum daily dosage should not exceed 5 doses (10 mL) within a 24-hour period. Healthcare professionals should be aware that excitability may occur, especially in pediatric patients, and marked drowsiness is also a potential side effect. As a precaution, this medication should be kept out of reach of children.

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, given the physiological changes associated with aging that may affect 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

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 nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of 10 mL (5 doses) is exceeded within a 24-hour period or if this product is taken concurrently with other medications containing acetaminophen.

Before administering this product, it is advised to consult a healthcare professional if the patient has a history of liver disease. In the event of an overdose, which may result from exceeding the recommended dosage, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial, even if the patient does not exhibit any signs or symptoms of liver damage.

Overdosage

Overdosage may result in significant liver damage, particularly when the recommended dosage is exceeded. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of overdose.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt intervention is crucial, even in the absence of noticeable signs or symptoms, as early treatment can mitigate the risk of severe complications.

Monitoring and management of the patient should be initiated as soon as possible to ensure appropriate care and to address any potential hepatic impairment that may arise from the overdose.

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

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance immediately.

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 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. It is important to avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. If there is uncertainty regarding whether a child's prescription includes an MAOI, patients should consult a healthcare professional.

Healthcare providers should caution patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. If there is any doubt about the presence of acetaminophen in other medications, patients should be encouraged to seek guidance from a doctor or pharmacist. Additionally, this product should not be used if the child has a known allergy 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 be advised to seek medical advice if pain, nasal congestion, or cough worsens or persists beyond five days, or if fever worsens or lasts more than three days. Furthermore, if nervousness, dizziness, or sleeplessness occurs, patients should stop use and contact a healthcare provider. In cases where a cough recurs or is accompanied by a rash or headache that lasts, patients should be made aware that these could indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dose due to the overdose warning. They should also be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible effect. The use of sedatives and tranquilizers may enhance drowsiness, and patients should be advised to consult a doctor before use if the 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. Additionally, patients should seek medical advice if the child has a persistent or chronic cough, particularly if it is associated with asthma or excessive phlegm.

Finally, patients should be encouraged to consult a doctor or pharmacist before using this product if the child is taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. Prior to use, the product must be shaken well to ensure proper consistency.

To maintain product integrity, it is crucial to observe the tamper-evident features. The product 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, with the option to repeat the dose every 4 hours as needed while symptoms persist. Clinicians should advise patients to keep the medication out of reach of children. Patients are instructed to discontinue use and consult a doctor if they experience new symptoms, redness or swelling, worsening pain, nasal congestion, or cough lasting more than 5 days, fever worsening or lasting more than 3 days, as well as nervousness, dizziness, or sleeplessness. Additionally, if a cough recurs or is accompanied by a rash or persistent headache, these may indicate a serious condition requiring medical attention.

Drug Information (PDF)

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

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