Childrens Cough and Chest Congestion

Description

Children's Genexa® Medicine Made Clean is formulated for children aged 4 to 11 years and is indicated for the relief of cough and chest congestion. The active ingredients include Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant that aids in the clearance of mucus. This product is designed to provide a therapeutic alternative comparable to the active ingredients found in Children's Robitussin® Cough & Chest Congestion DM.

The formulation is free from sodium benzoate, propylene glycol, sucralose, and other additives. It features an organic blueberry flavor for palatability. The dosage form is a liquid, supplied in a 4 fl oz (118 mL) bottle, with a dosing cup included for accurate measurement.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for children is as follows:

For children aged 6 to under 12 years, the dosage is 5 mL to 10 mL administered every 4 hours. For children aged 4 to under 6 years, the dosage is 2.5 mL to 5 mL, also given every 4 hours.

It is imperative that no more than 6 doses are administered within a 24-hour period. The medication should only be used with the enclosed dose cup; the use of any other dosing device is not recommended.

For children under 4 years of age, the medication is contraindicated and should not be used.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Prior to administration, healthcare professionals should verify whether the child's prescription includes an MAOI by consulting with a doctor or pharmacist.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this medication.

Warnings This medication must not be administered to a child who is 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 given for a period of 2 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 Before using this medication, it is advisable to consult a healthcare provider if the child presents with a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in conditions such as asthma.

Stop Taking and Call Your Doctor Instructions The use of this medication should be discontinued, and a healthcare provider should be contacted if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a child's prescription medication contains an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

Before using this product, it is advisable to consult a doctor if the child has a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in conditions such as asthma.

Patients should discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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

It is crucial to keep this product out of the reach of children to prevent accidental ingestion or misuse.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes prescription medications used for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Administration of this product in children who are currently taking an MAOI, or within 2 weeks of discontinuing such therapy, may lead to serious adverse effects.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the initiation 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 Cough and Chest Congestion (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product if they are taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. It is essential to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

For children with cough accompanied by excessive phlegm or persistent cough, such as that associated with asthma, a doctor should be consulted prior to use. If a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, the product should be discontinued, and medical advice sought, as these may indicate a serious condition.

Dosing instructions specify that children aged 6 to under 12 years may receive 5 mL to 10 mL every 4 hours, while those aged 4 to under 6 years may receive 2.5 mL to 5 mL every 4 hours. The product should not be administered to children under 4 years of age. It is critical to adhere to the maximum dosage of 6 doses within a 24-hour period and to use only the enclosed dosing cup, avoiding any other dosing devices.

Parents and caregivers should ensure that the product is 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 (1-800-222-1222) should be made.

Geriatric Use

There is no specific information regarding the use of this medication 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 possibility of altered pharmacokinetics and pharmacodynamics in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific circumstances of the overdose.

Healthcare providers are encouraged to remain vigilant and prepared to provide supportive care and symptomatic treatment as necessary.

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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. 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.

Providers should instruct patients to discontinue use and seek medical advice if a cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Additionally, healthcare providers should recommend that patients consult a doctor before using this medication if the child has a cough associated with excessive phlegm (mucus) or if the child experiences a persistent or chronic cough, such as that which occurs with asthma. This precaution ensures that the child receives appropriate care tailored to their specific health needs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients to consult a doctor before use if the child has a cough accompanied by excessive phlegm or if the cough is persistent or chronic, such as that associated with asthma.

Additionally, patients should be instructed to discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, as these may indicate a serious condition. In the event of an overdose, immediate medical assistance should be sought or the Poison Control Center contacted at 1-800-222-1222.

Drug Information (PDF)

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

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