Dextromethorphan hydrobromide/Guaifenesin

Description

EverPharm is an oral solution containing Dextromethorphan HBr and Guaifenesin, formulated as a cough suppressant and expectorant. Each 5 mL dose delivers 10 mg of Dextromethorphan HBr and 100 mg of Guaifenesin. The product is alcohol-free and sugar-free, with a cherry flavor for palatability. It is intended for institutional use only and is packaged in 100 unit-dose cups, each containing 5 mL of the solution. The National Drug Code (NDC) for this product is 84415-014-01.

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 from the bronchial tubes.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period.

For the formulation of 20 mg-200 mg per 10 mL, it is contraindicated for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 10 mL (1 unit dose) administered every 4 hours.

For the formulation of 10 mg-100 mg per 5 mL, it is contraindicated for use in children under 6 years of age. For children aged 6 to under 12 years, the recommended dosage is 5 mL (1 unit dose) every 4 hours. For adults and children aged 12 years and older, the recommended dosage is 10 mL (2 unit doses) every 4 hours.

Healthcare professionals should ensure that patients do not exceed the maximum dosage limit and adhere to the specified dosing intervals.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be used for at least 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.

Patients are advised to discontinue use and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by 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 accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to using this product to ensure safety for both the mother and child.

This product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is imperative that patients do not use this product if they are taking an MAOI or for at least 2 weeks after stopping such medication. Patients uncertain about the presence of an MAOI in their prescription should consult a healthcare professional prior to use.

Common adverse reactions may include a persistent cough. Patients are advised to stop using the product and seek medical advice if their cough lasts more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, patients should consult a doctor before using this product if they experience a cough that is associated with excessive phlegm or if they have a chronic cough due to conditions such as smoking, asthma, chronic bronchitis, or emphysema.

In the event of an accidental overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Dextromethorphan Hbr. and Guaifenesin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 5 mL (1 unit dose) every 4 hours. In contrast, adults and children over 12 years of age may take 10 mL (2 unit doses) every 4 hours. Caution is advised when considering use in pediatric populations, particularly in those under 12 years of age.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 available prescribing 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. 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 support 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 monitoring of the patient are essential.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should be prepared to implement appropriate interventions based on the clinical presentation and the specific substance involved. Continuous monitoring of vital signs and supportive measures may be necessary until the patient stabilizes.

In summary, immediate action is vital in cases of overdose, and healthcare professionals should ensure that patients and caregivers are aware of the appropriate steps to take in such situations.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare 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 the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and rash. These events have been documented in the context of routine pharmacovigilance activities.

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 accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should also counsel patients to discontinue use and consult a doctor 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 encouraged to seek medical advice before using the medication if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Care should be taken to ensure that the container remains intact; the product must not be used if the lid is torn or broken. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dextromethorphan Hbr. and Guaifenesin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)