Guaifenesin/Dextromethorphan hydrobromide

Description

Guaifenesin is present at a dosage of 400 mg, while dextromethorphan is included at 20 mg. The formulation combines these active ingredients to provide therapeutic effects. Guaifenesin serves as an expectorant, facilitating the clearance of mucus from the airways, while dextromethorphan acts as a cough suppressant. The specific roles of these components contribute to the overall efficacy of the product in managing symptoms associated with respiratory conditions.

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. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 softgel every 4 hours as needed. It is essential that the total number of doses does not exceed 6 doses within a 24-hour period. The softgel should be taken with a full glass of water to ensure proper swallowing and absorption.

Children under 12 years of age should not use this medication.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing an MAOI. Due to the potential for serious interactions, it is essential to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the prescribed medication.

Additionally, the product should not be used in excess of the recommended dosage or for a duration exceeding 7 days.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

General precautions must be observed, particularly regarding the concurrent use of prescription medications. This product should not be administered to individuals currently taking a monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, emotional conditions, or Parkinson's disease. Furthermore, it is essential to refrain from using this product for at least two weeks following the cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is any uncertainty regarding the presence of an MAOI in their prescription medications.

In the event of an accidental overdose, immediate medical assistance should be sought. Patients or caregivers are advised to contact a Poison Control Center without delay.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware that a cough lasting more than 7 days, recurring, or accompanied by fever, rash, or persistent headache may indicate a serious underlying condition that requires medical evaluation.

In addition, patients may experience a cough that is accompanied by excessive phlegm (mucus). It is important to note that persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, may also occur. These conditions warrant further assessment and management by healthcare professionals.

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 Guaifenesin, Dextromethorphan Hbr. 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 1 softgel every 4 hours, with a maximum of 6 doses in a 24-hour period. The duration of use should not exceed 7 days.

Healthcare professionals should advise caregivers to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the safety of both the mother and the developing fetus.

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

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is recommended to contact a poison control center or consult relevant toxicology resources for guidance on specific management strategies tailored to the situation. Continuous assessment and supportive care are critical in managing any adverse effects that may occur due to an overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should counsel patients to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

It is important to remind patients not to exceed the recommended dosage while using this product and to limit use to no more than 7 days. Additionally, patients should be advised to consult a doctor before using this product if they have a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F).

It is essential to keep the product in a dry place and to avoid exposure to heat to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for ensuring the product's quality throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)