Dextromethorphan hydrobromide/Guaifenesin

Description

Dextromethorphan HBr and Guaifenesin Oral Solution is formulated for institutional use only, delivering a dosage of 5 mg of dextromethorphan hydrobromide and 100 mg of guaifenesin per 5 mL. The product is packaged in a box containing 50 unit dose cups, each containing 5 mL of the solution. It is recommended to store the solution at temperatures ranging from 59°F to 86°F (15°C to 30°C). The National Drug Code (NDC) for this formulation is 81033-213-50.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritations, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 10 mL (2 teaspoonfuls) every 4 hours, not exceeding 6 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 5 mL (1 teaspoonful) every 4 hours, also with a maximum of 6 doses in a 24-hour period. In children aged 2 to under 6 years, the dosage is 2.5 mL (1/2 teaspoonful) every 4 hours, adhering to the same 6-dose limit. For children under 2 years of age, it is essential to consult a healthcare professional before administration.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be administered within two weeks of discontinuing an MAOI. Healthcare professionals are advised to confirm whether a patient’s prescription includes an MAOI by consulting with the patient or their pharmacist prior to initiating treatment with this product.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers should instruct patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be advised to discontinue use and consult their healthcare provider 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 and management.

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). The use of this product is contraindicated in patients taking MAOIs or within 2 weeks of stopping 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 symptoms that warrant immediate medical attention. Patients should discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Additionally, patients are encouraged to consult a healthcare provider prior to use if they experience a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require further evaluation and management.

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 aged 6 to under 12 years may be administered 5 mL (1 teaspoonful) every 4 hours. For children aged 2 to under 6 years, the recommended dosage is 2.5 mL (1/2 teaspoonful) every 4 hours. It is advised that healthcare professionals consult a doctor for dosing recommendations in children under 2 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. It is advisable to monitor these patients closely for any 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 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 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 may not have specific information regarding 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 optimal therapeutic outcomes.

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 information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is critical to document the circumstances surrounding the overdosage, including the amount ingested and the time of exposure, to facilitate appropriate treatment decisions.

In summary, due to the lack of specific overdosage information, a cautious and well-informed approach is recommended for the management of potential overdosage scenarios.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning 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 the medication 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 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 underlying condition.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. This ensures that the medication is appropriate for their specific health situation.

Storage and Handling

The product is supplied in unit dose cups of 5 mL and 10 mL. It is essential to store the product at a controlled room temperature of 20° to 25°C (68° to 77°F). For the unit dose cups, a temperature range of 15°C to 30°C (59°F to 86°F) is acceptable. Proper storage conditions must be maintained to ensure 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 Dextromethorphan Hbr and Guaifenesin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)