Guaifenesin/Dextromethorphan hydrobromide

Description

No description information is available for the specified drug.

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 assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Dosage and Administration

Adults and children 12 years of age and older 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. Each softgel should be taken with a full glass of water to ensure proper 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. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

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

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should ensure that patients are aware of this precaution and encourage them to consult with a doctor or pharmacist if there is any uncertainty regarding the presence of an MAOI in their current 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 to ensure appropriate management of the situation.

Patients should be instructed to discontinue use and consult a 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 intervention.

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 and 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

There are currently no documented drug interactions associated with 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, Dextromethorphan Hbr. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children 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.

It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

5. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

It is imperative that healthcare professionals document all findings and interventions thoroughly and communicate effectively with the patient’s care team to ensure comprehensive management of the overdose situation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, pruritus, and urticaria.

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 two weeks of stopping such medication. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription contains an MAOI.

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

Patients must be reminded not to exceed the recommended dosage and to limit the use of this product to no more than seven days. Additionally, healthcare providers should encourage patients to seek medical advice before using this product if they have a cough accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, particularly in cases related to 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 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)