Green Tussin Dm Pediatric

Description

This product is indicated for pediatric use and is represented in its packaging as shown in the referenced multimedia. The effective date for this labeling is March 22, 2024. The packaging includes a principal display panel that adheres to the specified code system. The associated image file is identified as "5528744306-3.jpg."

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. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating more productive coughs.

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

Dosage and Administration

The recommended dosage for children aged 6 to under 12 years is 15 mL (3 teaspoons) administered every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 2 to under 6 years, the dosage is 7.5 mL (1 ½ teaspoons) every 4 hours, also not to exceed 6 doses in a 24-hour period.

Healthcare professionals should ensure that the total daily dosage does not exceed the specified limits for each age group. Proper measuring devices should be used to ensure accurate dosing.

Contraindications

Use is contraindicated in the event of an accidental overdose; immediate medical assistance or contact with a Poison Control Center is required. Additionally, the product should be kept out of reach of children to prevent unintentional ingestion.

Warnings and Precautions

Healthcare professionals should adhere to the following warnings and precautions to ensure the safe use of this medication.

It is imperative not to exceed the recommended dosage. Prior to administration, healthcare providers should advise patients to consult a physician if they have a persistent or chronic cough, particularly in cases associated with asthma, chronic bronchitis, or if the cough is accompanied by excessive phlegm (mucus).

Patients should be instructed to discontinue use and seek medical advice if the cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

This medication is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional disorders, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the cessation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription, healthcare professionals should recommend consulting a doctor or pharmacist before proceeding with this treatment.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly if the recommended dosage is exceeded. It is crucial for patients to consult a healthcare professional before using this product if they have a persistent or chronic cough, such as that which occurs with asthma or chronic bronchitis, or if the cough is accompanied by excessive phlegm (mucus).

Patients are advised to discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, 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. MAOis are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOi, it is recommended to consult a healthcare professional or pharmacist prior to administration of this product.

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 to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Green Tussin Dm Pediatric (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not be administered this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks following the discontinuation of an MAOI.

For dosing, children aged 6 to under 12 years are recommended to receive 15 mL (3 teaspoons) every 4 hours. In children aged 2 to under 6 years, the recommended dose is 7.5 mL (1 ½ teaspoons) every 4 hours.

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 professional prior to 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. It is advised that caution be exercised, and medical advice should be sought before using this product during pregnancy.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

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 accidental 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 overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, gastrointestinal disturbances have been noted, including nausea and vomiting. Central nervous system effects, specifically dizziness and drowsiness, have also been reported.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety.

Additionally, healthcare providers should emphasize the necessity of keeping the medication out of reach of children. This precaution helps prevent accidental ingestion and potential harm to young children.

Storage and Handling

This 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 15 to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper handling should be observed to ensure the integrity of the product throughout its shelf life.

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 Green Tussin Dm Pediatric, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)