Mucinex Childrens Multi-Symptom Cold

Description

Mucinex® Children's MULTI-SYMPTOM COLD is a liquid formulation indicated for the relief of symptoms associated with the common cold. Each 4 FL OZ (118 mL) bottle contains the following active ingredients: Dextromethorphan HBr 5 mg, serving as a cough suppressant; Guaifenesin 100 mg, functioning as an expectorant; and Phenylephrine HCl 2.5 mg, acting as a nasal decongestant. This product is recommended for use in children aged 4 years and older and is flavored with Very Berry. The National Drug Code (NDC) for this product is 63824-949-01. The formulation is designed to relieve stuffy nose, control cough, relieve chest congestion, and break up mucus.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may help children achieve restful sleep. It also alleviates nasal congestion and a stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The maximum recommended dosage is six doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided, and this cup should not be used for any other products to ensure accurate dosing.

For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours as needed. For children aged 4 to under 6 years, the appropriate dose is 5 mL every 4 hours as needed. It is important to note that this product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise caregivers to adhere strictly to these dosing guidelines or any alternative dosing instructions provided by a physician.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to administration of this product. Additionally, it is contraindicated to exceed the recommended dosage while using this product.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

Healthcare professionals should advise caregivers to seek medical guidance before using this product if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm, or a persistent or chronic cough, such as that associated with asthma.

It is essential to adhere strictly to the recommended dosage when using this product. Exceeding the directed dosage may lead to adverse effects.

Caregivers should be instructed to discontinue use and consult a healthcare provider if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, medical advice should be sought. These symptoms may indicate a more serious underlying condition.

To ensure safety, this product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, medical advice should be sought. A cough that persists for more than 7 days, recurs, or occurs alongside fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson's disease. Administration of this product should be avoided in children who are currently taking an MAOI or have discontinued an MAOI within the past two weeks.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is strongly recommended.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Childrens Multi-Symptom Cold (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is important to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, cough with excessive phlegm, or a persistent cough associated with asthma.

When administering this product, it is crucial to adhere to the recommended dosage and not exceed 6 doses in any 24-hour period. The dosing should be measured using the provided dosing cup, which should not be used with other products. The recommended dosing is as follows: for children aged 6 to under 12 years, 10 mL every 4 hours; for children aged 4 to under 6 years, 5 mL every 4 hours. This product is not recommended for children under 4 years of age.

Parents and caregivers should monitor for any adverse effects, including nervousness, dizziness, or sleeplessness, and should discontinue use and consult a doctor if symptoms do not improve within 7 days, if the cough lasts more than 7 days, or if it is accompanied by fever, rash, or persistent headache.

Geriatric Use

Elderly patients may not have specific information regarding the use of Mucinex Children's Multi-Symptom Cold, as the drug insert does not provide data on geriatric use. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to adverse effects in this population.

Due to the lack of clinical findings specific to elderly patients, it is advisable to monitor for efficacy and safety closely. If any dose adjustments are warranted based on the individual patient's health status or concurrent medications, healthcare providers should make those determinations judiciously.

Pregnancy

The safety of Mucinex® Children's Multi-Symptom Cold during pregnancy has not been established. Pregnant patients or those planning to become pregnant are advised to consult a healthcare provider prior to use. There may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

While no specific dosage modifications for pregnant individuals are mentioned, it is essential for healthcare providers to offer personalized advice based on individual circumstances. Use of this medication during pregnancy should be approached with caution and under medical supervision to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of Mucinex® Children's Multi-Symptom Cold in lactating mothers. Additionally, there is no information available about the potential for excretion of this medication 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 have not been specifically studied in relation to this drug. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated phone number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

It is crucial to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if symptoms do not improve within seven days, or if they occur alongside fever. Patients should also be made aware that a cough lasting more than seven days, recurring cough, or cough accompanied by fever, rash, or persistent headache may indicate a serious condition and warrants medical evaluation.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, healthcare providers should advise patients to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, cough associated with excessive phlegm, or a persistent or chronic cough, such as that which occurs with asthma.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)