Childrens Robitussin Elderberry Cough and Chest Congestion Dm

Description

No description information is available for the 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 a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The maximum dosage for this product is limited to 6 doses within any 24-hour period. It is imperative that the dosing cup provided with the product is used for accurate measurement, and it should be kept with the product at all times.

For children under 4 years of age, the use of this product is not recommended. For children aged 4 to under 6 years, the recommended dosage is 5 mL administered every 4 hours. For children aged 6 to under 12 years, the dosage increases to 10 mL every 4 hours. Adults and children aged 12 years and older should take 20 mL every 4 hours.

Healthcare professionals should ensure that patients adhere to these guidelines to avoid exceeding the maximum dosage limit.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Due to the potential for serious interactions, it is essential to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Warnings and Precautions

The use of this product is contraindicated in individuals 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 discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to use if they experience a cough accompanied by excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Patients are advised to discontinue use and contact their healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs). The use of this product is contraindicated in patients currently taking MAOIs or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, and patients should discontinue use and seek medical advice if they experience these signs.

Additionally, patients should consult a doctor prior to use if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy, as this may result in serious interactions.

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 contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Robitussin Elderberry Cough and Chest Congestion Dm (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 4 years of age should not use this product. For children aged 4 to under 6 years, the recommended dosage is 5 mL every 4 hours. In children aged 6 to under 12 years, the dosage increases to 10 mL every 4 hours. For adolescents and adults aged 12 years and older, the dosage is 20 mL every 4 hours. The product is specifically labeled for use in children aged 4 years and older.

Geriatric Use

There is no specific information regarding the use of Children's Robitussin Elderberry Cough and Chest Congestion DM in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. It is advisable to monitor for potential adverse effects and to evaluate the appropriateness of the dosage in this population, as age-related physiological changes may affect drug metabolism and response. Given the lack of targeted clinical findings for geriatric use, individualized assessment and careful consideration of the patient's overall health status are recommended.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The involvement of poison control experts can provide additional guidance on the appropriate management strategies tailored to the specific circumstances of the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions associated with the use of this product. These include allergic reactions such as rash, pruritus, and urticaria; neurological effects including dizziness, confusion, somnolence, and hallucinations; gastrointestinal disturbances such as nausea and vomiting; and psychological symptoms including agitation. Additionally, serious adverse events such as respiratory depression, serotonin syndrome, increased heart rate, hypertension, seizures, and death have been reported.

Other adverse reactions not specifically listed may also occur. The safety of this product during pregnancy and lactation has not been established. There have been reports of misuse and abuse of dextromethorphan, as well as cases of overdose characterized by symptoms such as confusion, hallucinations, and respiratory depression. Caution is advised when administering this product to patients with a history of substance abuse. Adverse reactions can be reported to the FDA at 1-800-FDA-1088.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should also instruct patients to discontinue use and seek medical advice if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be advised to consult with their healthcare provider before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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 room temperature of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)