Dextromethorphan hydrobromide/Guaifenesin

Description

No relevant information is available for SPL code 34089-3.

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.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or respiratory conditions.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 5 mL administered every 4 hours. It is imperative that no more than 6 doses are taken within a 24-hour period to avoid potential overdose.

For accurate dosing, the provided dosing cup must be used to measure the medication. Healthcare professionals should advise patients to keep the dosing cup with the product to ensure proper administration.

This medication is not indicated for use in children under 12 years of age.

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 they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is uncertainty regarding the presence of an MAOI in a prescribed medication.

Patients should discontinue use and seek medical advice if a 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.

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. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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) for depression, psychiatric, or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in patients currently taking an MAOI 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 cough that is accompanied by excessive phlegm (mucus) or cough that is chronic, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should seek medical advice before using this product if they experience these symptoms.

Additionally, patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

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 confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 5 mL every 4 hours, with a maximum of 6 doses in any 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific geriatric use information, dosage adjustments, or safety concerns outlined in the prescribing information. 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 therapeutic response, given the general considerations associated with pharmacotherapy in the elderly 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

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additionally, reports have included central nervous system effects such as hallucinations, confusion, and agitation, as well as increased heart rate, respiratory depression, seizures, and hepatotoxicity.

The frequency of these adverse reactions is not known, and it is important to note that these reactions may not be directly related to the use of the product. Healthcare professionals are encouraged to report any adverse events or side effects to the appropriate regulatory authorities.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important for patients to understand the potential risks and benefits associated with its use during these periods.

Providers should also emphasize the necessity of keeping the medication out of reach of children. In the event of an overdose, patients must be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and effective management of any potential adverse situations.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled room temperature of 20° to 25°C (68° to 77°F). Refrigeration is not recommended, as it may compromise the integrity of the product.

Healthcare professionals are advised to retain the carton for future reference to ensure access to the full labeling information. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 5 mL every 4 hours for adults and children aged 12 years and older. Patients should not exceed 6 doses within a 24-hour period.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, 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 Dextromethorphan Hydrobromide and Guaifenesin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)