Leader Childrens Multi Symptom Cold

Description

Children's Multi-Symptom Cold is a formulation designed for pediatric use, indicated for children aged 4 years and older. This product contains three active ingredients: Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. The formulation is presented in a liquid dosage form with a volume of 4 fluid ounces (118 mL) and features a Very Berry flavor. It is intended to relieve symptoms associated with colds, including stuffy nose, chest congestion, control of cough, and the breakdown of 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 colds or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, thereby assisting children in achieving 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

Healthcare professionals should advise patients to adhere strictly to the following dosage and administration guidelines.

The maximum dosage should not exceed 6 doses within a 24-hour period. It is imperative to measure the medication using only the dosing cup provided with the product, and this cup should not be utilized for any other products to ensure accurate dosing.

For children aged 6 years to under 12 years, the recommended dose is 10 mL administered every 4 hours as needed. For children aged 4 years 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.

All dosing should be conducted in accordance with these guidelines or as directed by a healthcare provider.

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 such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician under the following circumstances: if the child experiences symptoms of nervousness, dizziness, or sleeplessness; if symptoms do not improve within 7 days or are accompanied by fever; or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache.

These precautions are essential to ensure the safe and effective use of the medication. Regular monitoring and prompt communication with healthcare providers can help mitigate potential risks associated with treatment.

Side Effects

Patients using this medication should be aware of certain warnings and recommendations regarding adverse reactions. While no specific side effects have been documented, it is important to monitor for signs that may indicate a need for medical consultation.

Parents should stop use and consult a doctor if their child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, it is advisable to seek medical advice. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may also signal a serious illness and warrants immediate medical attention.

Before administering this medication, it is recommended to consult a healthcare professional if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or a persistent or chronic cough, such as that associated with asthma. Furthermore, caution is advised if the cough is accompanied by excessive phlegm (mucus).

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

The use of this product 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, this product should not be administered for a period of two weeks following the discontinuation of an MAOI. It is advised that caregivers consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their child's prescription includes an MAOI before administering this product.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 4 years and older may use this product, with specific dosing recommendations based on age. For children aged 6 years to under 12 years, the recommended dose is 10 mL every 4 hours. For those aged 4 years to under 6 years, the dose is 5 mL every 4 hours. This product is not indicated for children under 4 years of age.

Healthcare professionals should advise caregivers to avoid using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Additionally, it is important to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as occurs with asthma), or cough associated with excessive phlegm.

While using this product, caregivers should ensure that the dosage does not exceed the recommended amount. They should also be instructed to stop use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be advised against the use of this product in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric conditions, or Parkinson's disease. The use of this product is contraindicated in individuals currently taking an MAOI or within 2 weeks of discontinuing such treatment. Healthcare professionals should ensure that patients are aware of this interaction and confirm whether any prescribed medications contain an MAOI.

Additionally, it is recommended that healthcare providers inquire about any underlying health conditions in pregnant patients, including heart disease, high blood pressure, thyroid disease, diabetes, or chronic cough, such as that associated with asthma. These conditions may necessitate further evaluation before the use of this product.

Healthcare professionals should emphasize the importance of keeping this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) should be made without delay.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. For patients with significant renal impairment, a reduced dose is recommended to mitigate potential risks associated with inadequate drug clearance.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms of overdose can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should consider the possibility of administering activated charcoal if the patient presents within a suitable timeframe and if it is deemed appropriate based on the clinical scenario.

Overall, due to the lack of specific overdosage information, a cautious and individualized approach is paramount in managing potential overdose cases.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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. 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. If there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a healthcare professional if the child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, patients should be advised to seek medical advice. It is also important to inform patients that they should stop use and consult a doctor if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, as these may indicate a serious illness.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a persistent or chronic cough, such as that associated with asthma. Furthermore, patients should be advised to seek medical advice if the child has a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 15-30 ºC (59-86 ºF). It is important to note that refrigeration is not permitted for this product. Proper adherence to these storage conditions is essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)