Guaifenesin and Dextromethorphan Hydrobromide

Description

Guaifenesin and Dextromethorphan are available in two dosage forms: 16 oz and 8 oz. These formulations combine the expectorant properties of guaifenesin with the cough suppressant effects of dextromethorphan. The specific molecular weights and chemical formulas for each component are not provided, but both ingredients are commonly used in the management of cough and mucus congestion. The products are typically presented in liquid form, suitable for oral administration.

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 the common cold or inhaled irritants. It is effective in reducing the intensity of coughing and helps suppress the impulse to cough, thereby assisting with sleep.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is 2 teaspoonfuls (10 mL) every 4 hours. The total daily dosage should not exceed 12 teaspoonfuls within a 24-hour period, unless otherwise directed by a physician.

For children aged 6 to under 12 years, the dosage is 1 teaspoonful (5 mL) every 4 hours, with a maximum of 6 teaspoonfuls in a 24-hour period, unless otherwise directed by a physician.

For children under 6 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Administration should be performed using the provided measuring device to ensure accurate dosing.

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

Exceeding the recommended dosage of this product is strictly prohibited. Adherence to the prescribed dosage is essential to ensure safety and efficacy.

This product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is important to refrain from using this product 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 current prescription medications.

Patients are instructed to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

No specific emergency medical instructions are provided; however, healthcare professionals should remain vigilant and prepared to address any adverse reactions or complications that may arise during the use of this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial to adhere to the recommended dosage, as exceeding this may lead to serious side effects.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Monitoring for these adverse reactions is essential to ensure patient safety and effective management of any potential complications.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are a class of medications commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Patients should not use this product while taking an MAOI 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. This precaution is critical to avoid potential adverse effects associated with the interaction between this product and MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Guaifenesin and Dextromethorphan Hydrobromide (guaifenesin and dextromethorphan hydrobromide syrup). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1 teaspoonful (5 mL) every 4 hours, with a maximum dosage of 6 teaspoonfuls in a 24-hour period, unless otherwise directed by a physician. For children under 6 years of age, it is advised to consult a physician prior to use.

Geriatric Use

There is no specific information available 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.

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 healthcare professional prior to using this medication. There is no specific data available regarding 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and 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 accidental overdose, it is imperative to seek professional medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Monitoring for signs of toxicity is essential, and appropriate management should be initiated based on the clinical presentation and the substance taken.

Management procedures may include supportive care, symptomatic treatment, and specific interventions as indicated. Continuous assessment of the patient's condition is necessary to ensure optimal outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, 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

Reports of side effects associated with the use of the product have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to Oncor Pharmaceuticals at 1-443-876-7600, available from 9 a.m. to 5 p.m. EST, or to the FDA at 1-800-FDA-1088.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Patients should be instructed to stop using the product and seek medical advice if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Additionally, healthcare providers should recommend that patients consult with a doctor before using this product if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence through a foil seal located under the cap. It is imperative that the product is not used if the foil seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 59° to 86°F (15° to 30°C), in accordance with USP Controlled Room Temperature guidelines. Proper adherence to these storage conditions is essential 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.

For postmarketing experience, patients are encouraged to report any side effects by contacting Oncor Pharmaceuticals at 1-443-876-7600 during business hours (9 a.m. to 5 p.m. EST) or by calling the FDA at 1-800-FDA-1088.

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)