Dextromethorphan hydrobromide/Guaifenesin/Phenylephrine hydrochloride

Description

NDC 69367-184-08 is a formulation designed for the relief of cough and cold symptoms, specifically targeting congestion. Each 15 mL (1 tablespoon) dose contains 18 mg of Dextromethorphan HBr, 200 mg of Guaifenesin, and 10 mg of Phenylephrine HCl, providing a combination of a cough suppressant, expectorant, and nasal decongestant. The product is presented in an 8 fl. oz. (240 mL) bottle and features a raspberry flavor. It is formulated to be alcohol-free, sugar-free, gluten-free, and dye-free. This product is manufactured by Westminster Pharmaceuticals.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may aid in promoting sleep. It also alleviates nasal congestion associated with colds.

Limitations of use include the absence of teratogenic or nonteratogenic effects, as no such information is provided.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 15 mL (1 tablespoon) every 4 hours, with a maximum limit of 90 mL (6 tablespoons) within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 7.5 mL (1/2 tablespoon) every 4 hours, not to exceed 45 mL (3 tablespoons) in a 24-hour period.

For children under 6 years of age, it is essential to consult a healthcare professional for appropriate dosing recommendations.

The medication should be measured using the enclosed dosage cup or a tablespoon to ensure accurate dosing. It is important not to exceed 6 doses in any 24-hour period.

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 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

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, this product 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 they are uncertain whether their prescription medication contains an MAOI.

Prior to using this product, it is essential for patients to seek medical advice if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a chronic cough associated with smoking, asthma, or emphysema, a cough that produces excessive phlegm, or difficulty urinating due to prostate gland enlargement.

Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

If any of the following occur, patients should discontinue use and consult a healthcare professional: nervousness, dizziness, or sleeplessness; lack of improvement in symptoms within seven days; the presence of fever, rash, or persistent headache; or the emergence of new symptoms. It is important to note that a persistent cough may indicate a serious underlying condition.

This product should be stored out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms occur, if symptoms do not improve within 7 days, or if they are accompanied by fever, rash, or persistent headache. Additionally, a persistent cough may indicate a serious underlying condition and should be evaluated by a healthcare provider.

Common adverse reactions may include new symptoms that arise during treatment. Patients are advised to seek medical advice before using this product if they have pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or chronic cough associated with smoking, asthma, or emphysema. Furthermore, individuals experiencing a cough with excessive phlegm or difficulty urinating due to prostate gland enlargement should also consult a healthcare professional prior to use.

It is important to note that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients must refrain from using this product while taking an MAOI or for 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients should seek clarification from a doctor or pharmacist before proceeding with this product.

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 medication contains an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 7.5 mL (1/2 tablespoon) every 4 hours, with a maximum dosage not to exceed 45 mL (3 tablespoons) in a 24-hour period. For children under 6 years of age, it is advised to consult a doctor prior to administration.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 remain alert to any signs of toxicity or adverse reactions that may occur.

Management of an overdose should be guided by clinical judgment and may involve supportive care, symptomatic treatment, and specific interventions as deemed necessary based on the patient's condition and the substance involved. Continuous assessment and monitoring of the patient are recommended to ensure appropriate management and to address any complications that may arise.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. 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 counsel patients to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and consult a doctor if their symptoms do not improve within seven days or if they develop a fever, rash, or persistent headache, as a persistent cough may indicate a serious condition. Patients should also be instructed to stop use and contact a healthcare professional if any new symptoms arise.

It is important to remind patients to adhere to the recommended dosage and not exceed the directed amount when using this product. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a chronic cough (such as that associated with smoking, asthma, or emphysema), a cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

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 temperature range of 68° to 86°F (20° to 30°C) to maintain its efficacy and stability. Proper storage conditions 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 Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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