Elp Essential Dm

Description

elp essential DM-139 is a pharmaceutical compound identified by its unique formulation. The specific chemical properties, including its molecular weight and chemical formula, are integral to its characterization. This compound is presented in a dosage form suitable for its intended therapeutic application. The appearance of elp essential DM-139 is consistent with its formulation standards, ensuring quality and efficacy in its use.

Uses and Indications

This drug is indicated to help loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of cough. It is also indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold.

Limitations of Use: This drug is not intended for the treatment of chronic cough associated with smoking, asthma, or emphysema.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 10 ml (2 teaspoons) administered every 4 hours. For children aged 6 to under 12 years, the dosage is 5 ml (1 teaspoon) every 4 hours. It is important to note that no more than 6 doses should be taken within a 24-hour period.

Prior to administration, the product must be shaken well to ensure proper mixing. The use of this medication is not recommended for children under 6 years of age.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage to avoid potential adverse effects. The use of this product is contraindicated in several scenarios. It must not be taken concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications used for depression, psychiatric conditions, or Parkinson's disease. Additionally, this product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Individuals with chronic pulmonary diseases or those experiencing shortness of breath should refrain from using this product unless specifically directed by a healthcare provider. Furthermore, the consumption of alcoholic beverages is strongly discouraged while taking this medication, as it may exacerbate side effects.

General precautions should be observed, particularly in patients presenting with a cough that is productive of excessive phlegm or mucus, or in those with a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Consultation with a healthcare provider is recommended before initiating treatment in these cases.

Patients are advised to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, it is crucial to contact a healthcare professional, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay to ensure appropriate management.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly if the recommended dosage is exceeded. It is crucial for patients to avoid using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should consult their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI. Additionally, individuals with chronic pulmonary diseases or those experiencing shortness of breath should only use this product under medical supervision.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur. Furthermore, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, patients should seek medical advice, as these may indicate a serious underlying condition.

Patients who are pregnant or breastfeeding should consult a healthcare professional before using this product. In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. It is also recommended to avoid alcoholic beverages while taking this product to prevent potential adverse effects.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product if they are currently on an MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, certain psychiatric conditions, or Parkinson's disease. It is advisable for patients to consult their healthcare provider or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Additionally, the consumption of alcoholic beverages is not recommended during the use of this product. This precaution is essential to avoid potential adverse effects that may arise from the interaction between alcohol and the active ingredients in this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered a dosage of 5 mL (1 teaspoon) every 4 hours. For children under 6 years of age, the use of this medication is not recommended.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 drug 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 available data 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 information necessitates careful clinical judgment and monitoring.

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. 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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident feature. It is essential to inspect the seal under the cap prior to use; the product should not be utilized if the seal is torn, broken, or missing.

For optimal storage, the product must be kept within a temperature range of 15-30° C (59-86° F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Elp Essential Dm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)