Dextromethorphan hydrobromide/Guaifenesin

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation. 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

Adults and children aged 12 years and older are advised to take 2 teaspoonfuls (TSP) every 4 hours as needed. For children aged 6 to 12 years, the recommended dosage is 1 teaspoonful (TSP) every 4 hours.

It is important to note that no more than 6 doses should be administered within a 24-hour period. This product is not intended for use in children under 6 years of age.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to any of its ingredients.

Additionally, if a cough persists for more than 7 days or is accompanied by fever, rash, or headaches that last, the product should be discontinued, and a healthcare professional should be consulted, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the use of this product is contraindicated 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 current prescription medications.

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

Patients are advised to discontinue use and consult a healthcare provider if any of the following occur: a cough that persists for more than seven days, a cough accompanied by fever, rash, or persistent headaches, as these symptoms may indicate a serious underlying condition. Additionally, if a patient experiences hypersensitivity to any of the product's ingredients, they should stop taking the product and seek medical advice.

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 crucial to avoid using this product if a patient is taking an MAOI or has stopped taking one within the last two weeks, as this could lead to significant interactions.

Common adverse reactions may include hypersensitivity to any of the ingredients in the formulation. Patients experiencing such reactions should discontinue use and consult a healthcare professional.

Additionally, patients are advised to stop using the product and seek medical attention if their cough persists for more than seven days or is accompanied by fever, rash, or headaches that last. These symptoms may indicate a serious underlying condition that requires further evaluation.

Before using this product, patients should consult a healthcare provider if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, those with a cough accompanied by excessive phlegm (mucus) should also seek medical advice prior to use.

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. The combination may result in serious interactions that could pose significant health risks. It is essential for healthcare providers to ensure that patients are not concurrently using MAOIs before initiating treatment with this medication.

Packaging & NDC

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

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For those aged 12 years and older, the recommended dosage is 2 teaspoonfuls (TSP) every 4 hours. In children aged 6 to 12 years, the dosage is reduced to 1 teaspoonful (TSP) every 4 hours. It is contraindicated for use in children under 6 years of age.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects when using this product, and there is a likelihood of reduced kidney function in this population. Therefore, caution is advised when administering this medication to geriatric patients.

While specific geriatric use information is not explicitly provided in the prescribing information, healthcare providers should consider the potential need for dosage adjustments based on individual patient assessments. The standard dosage for adults and children aged 12 years and older is 2 teaspoonfuls (TSP) every 4 hours. However, due to the aforementioned factors, careful monitoring of elderly patients is recommended to ensure safety and 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to ensure patient safety and to mitigate any potential adverse effects.

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 the following adverse reactions reported voluntarily or through surveillance programs: hypersensitivity reactions, which include rash, urticaria, and angioedema.

Patient Counseling

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

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It is essential to inspect the seal cap prior to use; the product should not be utilized if the seal cap is broken or missing, as this may compromise the quality and efficacy of the product.

For optimal storage, the product should be kept in a controlled environment, away from extreme temperatures and humidity. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to maintain product stability and effectiveness. Special handling needs are not specified, but care should be taken to avoid any conditions that may affect the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)