Guaifenesin/Dextromethorphan hydrobromide

Description

Guaifenesin Syrup and Dextromethorphan HBr is a pharmaceutical formulation containing 100 mg of guaifenesin and 10 mg of dextromethorphan hydrobromide per 5 mL. This product is intended for institutional use only. It is manufactured by Dash Pharmaceuticals LLC, located in Upper Saddle River, NJ 07458. The lot number for this specific formulation is 111, with an expiration date of September 22, 2020.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. 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

For adults and children aged 12 years and over, the recommended dosage is 10 mL administered every 4 hours as needed. The maximum allowable dose should not exceed 60 mL within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. This is due to the potential for serious interactions that may occur when these medications are combined.

Warnings and Precautions

Use of this medication is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI.

Healthcare professionals should advise patients to consult a doctor prior to use if they experience a cough associated with excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be encouraged to seek guidance from a doctor or pharmacist if they are taking any other medications to avoid potential interactions.

Patients must discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. Furthermore, individuals who are hypersensitive to any of the ingredients should refrain from using this product.

For those who are pregnant or breastfeeding, it is essential to seek advice from a health professional before using this medication.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is crucial to avoid the use of this medication in such cases.

Common adverse reactions may include hypersensitivity to any of the ingredients, which necessitates discontinuation of the medication and consultation with a healthcare professional. Patients experiencing a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache should also stop use and seek medical advice.

Additionally, patients with a cough that occurs with excessive phlegm or those with chronic cough conditions, such as smoking, asthma, chronic bronchitis, or emphysema, should consult a doctor before using this medication.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a health professional prior to use. It is also important to keep this medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center should be made at 1-800-222-1222.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on an MAOI or for a period of two weeks following the discontinuation of the MAOI treatment due to the potential for serious interactions.

Additionally, it is advised that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any other drugs. This precaution is essential to ensure safety and to mitigate the risk of adverse interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 10 mL every 4 hours, with a maximum dose of 60 mL within a 24-hour period. Caution is advised when administering this medication to younger children.

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 therapeutic response, 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 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of an MAOI. They should be instructed to stop using the medication and consult a healthcare provider if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache.

It is important to advise patients to discontinue use and seek medical advice if they experience hypersensitivity to any of the ingredients in the medication. Additionally, patients should be encouraged to consult a healthcare provider before using the medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

Lastly, patients should be reminded to consult with a doctor or pharmacist before using this medication if they are taking any other drugs to avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature ranging from 20 to 25ºC (68 to 77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product.

To ensure optimal preservation, the container must be kept tightly closed at all times. Additionally, the product should not be used if the lid seal is open or damaged, as this may indicate contamination or degradation. Proper adherence to these storage and handling guidelines is essential for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential 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 at 1-800-222-1222. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)