Guaifenesin/Dextromethorphan hydrobromide

Description

No description information is available for the specified 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 helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, aiding in the ability to sleep.

Dosage and Administration

Extended-release tablets should not be crushed, chewed, or broken prior to administration. Each tablet must be taken with a full glass of water. This medication can be administered without regard to the timing of meals. It is contraindicated for use in children under 12 years of age.

For the 600 mg/30 mg formulation, adults and children aged 12 years and older may take 1 or 2 extended-release tablets every 12 hours, with a maximum dosage of 4 extended-release tablets within a 24-hour period.

For the 1200 mg/60 mg formulation, adults and children aged 12 years and older should take 1 extended-release tablet every 12 hours, with a maximum dosage of 2 extended-release tablets in a 24-hour period.

Contraindications

Use of this product is contraindicated in the following situations:

• Children under 12 years of age.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

General precautions should be observed prior to use. Patients should be advised to seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider before using this product.

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.

Patients should discontinue use and consult a healthcare professional if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients should 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 may indicate a serious underlying condition.

Before using this product, patients are advised to seek medical advice if they have a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider prior to use.

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. Safety and efficacy have not been established in this age group, and therefore, its use is contraindicated for children in this category.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may develop during the course of treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, 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 have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated contact number provided for this purpose.

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 to inform patients that this product is not recommended for use in children under 12 years of age.

Patients should be cautioned against using 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. They should also be informed that this product should not be used for 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 prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Additionally, healthcare providers should advise patients to consult a doctor before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. It is also advisable for patients to seek medical advice 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°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

For the 600 mg/30 mg formulation, adults and children aged 12 years and older are advised to take 1 or 2 extended-release tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. For the 1200 mg/60 mg formulation, the recommended dosage is 1 extended-release tablet every 12 hours, not exceeding 2 tablets in 24 hours.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)