Guaifenesin/Dextromethorphan hydrobromide

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, which may assist patients in achieving restful sleep.

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

Dosage and Administration

The extended-release tablet should be taken with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken, as this may affect the release mechanism of the medication.

For adults and children aged 12 years and older, the recommended dosage is one extended-release tablet every 12 hours. The total daily dosage should not exceed two extended-release tablets within a 24-hour period. This medication can be administered without regard to the timing of meals.

Use of this product is not recommended for children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the directed use may lead to adverse effects.

Warnings and Precautions

Patients should not use this product in individuals under 12 years of age. The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

In the event of an overdose, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should discontinue use and consult a healthcare provider if a 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.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, and it is crucial 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 could indicate a serious underlying condition.

This product is contraindicated in children under 12 years of age. Additionally, it should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications. Patients are advised to consult a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient data to support its safety and efficacy in this age group. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children younger than 12 years.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 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

There is no specific information 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 warranted 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to ensure patient safety and to mitigate any potential adverse effects.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Postmarketing experience includes reports of various adverse reactions that were voluntarily reported or identified through surveillance programs. These reactions encompass allergic reactions, including anaphylaxis, as well as skin reactions such as rash, urticaria, and pruritus. Gastrointestinal disturbances, including nausea and vomiting, have also been noted.

Additional reported events include dizziness and drowsiness, along with neurological symptoms such as hallucinations and confusion. Cardiovascular effects, including increased heart rate (tachycardia) and elevated blood pressure, were observed. Respiratory depression has been documented, as well as cases of serotonin syndrome, particularly in patients concurrently using serotonergic medications.

These adverse reactions were reported during the postmarketing experience and may not be included in the prescribing information.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important for patients to be informed that they should 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.

Patients should be instructed to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being one extended-release tablet every 12 hours, not exceeding two tablets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center 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 and Dextromethorphan Hbr, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)