Childrens Plus Multi Symptom Cold

Description

No description information is available for the specified drug.

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 children 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 children 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 physician. For children under 4 years of age or 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 5 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

Children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such medication within the past two weeks. This is 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 non-prescription, is contraindicated. 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 of the inactive ingredients contained in this formulation.

Additionally, this product is not intended to induce sleepiness in children and should not be used for this purpose. The recommended dosage should not be exceeded, as doing so may lead to overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding 5 doses (10 mL) within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen can significantly increase the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: new symptoms arise, redness or swelling is observed, pain, nasal congestion, or cough worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, or if nervousness, dizziness, or sleeplessness develops. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, these may be indicative of a serious underlying condition requiring medical evaluation.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center (1-800-222-1222) without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses (10 mL) within a 24-hour period, which is the maximum daily amount, 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.

Additionally, a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a healthcare provider.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility. The use of sedatives and tranquilizers may exacerbate drowsiness.

Patients are advised to stop use and consult a doctor if new symptoms arise, if redness or swelling is observed, or if pain, nasal congestion, or cough worsens or persists beyond five days. Furthermore, if fever worsens or lasts more than three 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 a rash or headache that lasts should also prompt a consultation with a healthcare professional.

It is critical to note that taking more than the recommended dose may lead to overdose and subsequent liver damage. In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. Administration of this product in children who are currently taking an MAOI or within 2 weeks of discontinuing an MAOI may result in serious interactions.

Additionally, caution is advised when using this product in conjunction with warfarin, a blood-thinning medication. The potential for increased anticoagulant effects necessitates consultation with a healthcare professional prior to co-administration. Monitoring of coagulation parameters may be warranted to ensure patient safety.

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 may receive a dose of 10 mL if they weigh between 48 and 95 pounds. For children aged 4 to 5 years weighing between 36 and 47 pounds, use is not recommended unless directed by a healthcare professional. The product is contraindicated in children under 4 years of age who weigh less than 36 pounds.

Caution is advised due to the presence of acetaminophen, as severe liver damage may occur if more than 5 doses (10 mL) are taken within a 24-hour period. Additionally, this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication.

Healthcare professionals should inquire about any pre-existing conditions before administration, including liver disease, glaucoma, thyroid disease, diabetes, heart disease, high blood pressure, or respiratory issues such as chronic bronchitis or asthma-related cough.

While using this product, excitability may occur, particularly in children, and marked drowsiness is also a potential side effect. It is essential to keep this medication out of reach of children.

In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is crucial for both children and adults, even if no symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against the use of this product in children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. The use of MAOIs, which are prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease, may pose significant risks.

Additionally, healthcare professionals should inquire about any liver disease in the child before recommending this product, as liver impairment may affect the safety and efficacy of the treatment. It is also crucial to ensure that the child is not allergic to acetaminophen or any of the inactive ingredients contained in this product, as allergic reactions could lead to serious adverse effects.

Given these considerations, healthcare providers should exercise caution and conduct a thorough assessment before prescribing this product to pregnant patients with children who may require treatment.

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 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 consult a healthcare professional prior to use, particularly if there is a history of liver disease. It is critical 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 (10 mL) within a 24-hour period, which is the maximum daily amount.

Additionally, caution is advised when this product is used in conjunction with other medications containing acetaminophen, as this combination may also result in severe liver damage. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dosage 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, individuals should seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. This action is essential for both adults and children, as timely intervention can mitigate the risk of severe complications.

Healthcare providers should be aware that symptoms may not be immediately apparent. Therefore, even in the absence of noticeable signs or symptoms, it is vital to pursue quick medical evaluation and management to ensure patient safety and appropriate care.

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

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, as exceeding this amount may lead to liver damage. 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 for both adults and children, even if no symptoms are initially apparent.

Patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. Additionally, the use of sedatives and tranquilizers may exacerbate drowsiness, and patients should be cautioned accordingly.

Before using this medication, patients should consult a healthcare professional if the child has any of the following conditions: liver disease, glaucoma, thyroid disease, diabetes, heart disease, high blood pressure, or respiratory issues such as chronic bronchitis or a persistent cough associated with excessive mucus. It is also advisable to seek guidance from a doctor or pharmacist if the child is currently taking sedatives, tranquilizers, or the anticoagulant medication warfarin.

Patients should be instructed to discontinue use and consult a healthcare provider if new symptoms arise, if there is any redness or swelling, if pain, nasal congestion, or cough worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if symptoms such as nervousness, dizziness, or sleeplessness occur. Additionally, they should seek medical advice if a cough recurs or is accompanied by a rash or a headache that lasts, as these may indicate a serious condition.

Storage and Handling

The product is supplied in a container that includes a dosing cup for accurate measurement. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration to maintain its efficacy. Prior to use, the product must be shaken well to ensure proper mixing. For safe handling, it is recommended to discard the product after opening, although specific guidelines for disposal are not explicitly stated.

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. 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 for both adults and children, even if no signs or symptoms are apparent.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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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