Childrens Multi Symptom Cold

Description

Guaifenesin, an expectorant, is present at a concentration of 100 mg per 4 FL OZ (118 mL) dosage form. Dextromethorphan HBr, a cough suppressant, is included at 5 mg, while Phenylephrine HCl, a nasal decongestant, is formulated at 2.5 mg. The product is sugar-free and alcohol-free, with a berry flavor contributing to its sensory profile.

Uses and Indications

This drug is indicated for the relief of cough and nasal congestion associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the expulsion of bothersome mucus and making coughs more productive.

The drug temporarily relieves the following symptoms:

• Cough due to minor throat and bronchial irritation.

• The intensity of coughing.

• The impulse to cough, aiding in sleep for children.

• Nasal congestion and stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects mentioned.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage guidelines. The maximum allowable dosage is 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 used for any other products to ensure accurate dosing.

For children aged 6 years to under 12 years, the recommended dose is 10 mL 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. The medication is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that caregivers understand these instructions to promote safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be administered for a period of 2 weeks following the discontinuation of an MAOI. 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 use.

Furthermore, the product should not be used in excess of the recommended dosage.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product in pediatric patients.

Warnings This product must not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a period of two weeks following the cessation of an MAOI. If there is uncertainty regarding whether a child’s prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

General Precautions Prior to use, it is advisable to consult a healthcare provider if the child has any of the following conditions:

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• A cough that produces excessive phlegm (mucus)

• A persistent or chronic cough, such as that associated with asthma

Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222 without delay.

Stop Taking and Call Your Doctor Instructions Parents or guardians should discontinue use and consult a healthcare provider if the child experiences any of the following:

• Nervousness, dizziness, or sleeplessness

• Symptoms that do not improve within seven days or are accompanied by fever

• A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience symptoms such as 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 indicate a serious underlying condition and warrants immediate medical attention.

Before using this product, it is important for caregivers to consult a healthcare provider if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or if the cough is associated with excessive phlegm (mucus) or is a persistent or chronic cough, such as that which occurs with asthma.

This product should not be administered to 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. Caregivers should verify with a healthcare professional or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

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, psychiatric disorders, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 14 days following the discontinuation of such therapy.

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 to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has a history of heart disease, high blood pressure, thyroid disease, or diabetes.

Dosage recommendations for pediatric patients are as follows: for children aged 6 years to under 12 years, the recommended dose is 10 mL every 4 hours; for children aged 4 years to under 6 years, the dose is 5 mL every 4 hours. This medication is not recommended for children under 4 years of age.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 from an overdose. Symptoms 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include cough characterized by excessive phlegm, as well as persistent or chronic cough, which may be associated with conditions such as asthma. Additional reported symptoms include nervousness, dizziness, and sleeplessness in children.

It is important to note that symptoms persisting beyond 7 days, or those that occur alongside fever, rash, or persistent headache, may indicate a serious underlying condition. Such cases warrant further medical evaluation.

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 patients are uncertain whether their child's prescription includes an MAOI, they 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 doctor if their child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to seek medical advice if symptoms do not improve within seven days or if they are accompanied by fever. It is important to inform patients that they should stop use and contact 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 condition.

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

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product. Additionally, the product must not be used if the printed neckband is broken or missing, as this indicates potential tampering or compromise of the product's safety. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. Patients are advised not to exceed the recommended dosage and to discontinue use while consulting a doctor if they experience a cough accompanied by excessive phlegm, a persistent cough (such as that associated with asthma), or if their child exhibits nervousness, dizziness, or sleeplessness. Additionally, patients should seek medical advice if symptoms do not improve within 7 days, if the cough lasts more than 7 days, or if it recurs with fever, rash, or persistent headache, as these may indicate a serious condition.

Patients should measure the medication using the dosing cup provided and should not use this cup with other products. The product should not be used if the printed neckband is broken or missing, and it should be stored at a temperature of 20-25°C (68-77°F).

Drug Information (PDF)

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

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