Kids Cough and Chest Congestion

Description

No description information is available for the specified drug.

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 mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Healthcare professionals are advised to ensure that the medication is shaken well before each use. The dosing should be administered using only the enclosed dose cup; the use of any other dosing device is not recommended.

For children aged 6 to under 12 years, the recommended dosage is 5 mL to 10 mL every 4 hours, with a maximum of 6 doses in any 24-hour period. For children aged 4 to under 6 years, the dosage is 2.5 mL to 5 mL every 4 hours, also adhering to the maximum limit of 6 doses within a 24-hour timeframe.

It is important to note that this medication is not indicated for use in children under 4 years of age.

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, such as a doctor or pharmacist, is advised prior to use.

Warnings and Precautions

Use of this product is contraindicated in 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, this product should not be administered for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Healthcare providers should exercise caution and recommend that caregivers seek medical advice prior to administering this product if the child presents with a cough accompanied by excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that associated with asthma.

Caregivers are instructed to discontinue use and consult a healthcare professional if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is essential to ensure the safety and well-being of the child.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious warnings include the contraindication of use in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this could lead to significant health risks.

Before administering this medication to a child, it is advisable to consult a healthcare professional if the child has a cough that is accompanied by excessive phlegm or if the cough is persistent or chronic, such as that which occurs with asthma.

Patients are also advised 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 that lasts, as these symptoms may indicate a serious underlying condition.

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.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks following the discontinuation of an MAOI. Co-administration in these circumstances may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the stated contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Kids Cough and Chest Congestion (dextromethorphan hbr, guaifenesin). 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 cough accompanied by excessive phlegm, or if the cough is persistent or chronic, such as that associated with asthma.

If the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache that lasts, the use of this medication should be discontinued, and a doctor should be consulted.

For dosing, children aged 6 to under 12 years may receive 5 mL to 10 mL every 4 hours. Children aged 4 to under 6 years may receive 2.5 mL to 5 mL every 4 hours. This medication is not recommended for children under 4 years of age.

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 before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information. No specific dosage modifications for pregnant individuals are mentioned, and it is recommended that healthcare providers be consulted for personalized advice. Special precautions should be taken, and the use of this medication should be discussed with a healthcare professional if the patient is pregnant.

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 concerns have been identified in the available information.

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 patients 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 this medication. Consequently, there are no 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. 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. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to address any complications that may arise during the management of an overdose.

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 a range of adverse reactions associated with the use of the product. These include allergic reactions such as rash, pruritus, and urticaria; neurological effects including dizziness, drowsiness, confusion, agitation, and hallucinations; gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and diarrhea; cardiovascular effects including increased heart rate; and severe outcomes such as respiratory depression, seizures, and death.

These reactions were reported voluntarily or through surveillance programs in patients using the product and may not be directly related to its use. The frequency of these adverse reactions is not known. Additionally, there have been reports of misuse and abuse of the product. Healthcare professionals are encouraged to report any adverse events or side effects to the FDA.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a 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 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 more serious condition that requires medical evaluation.

Additionally, healthcare providers should recommend that patients seek medical advice 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.

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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)