Dextromethorphan hydrobromide/Guaifenesin

Description

No description information is available for the 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. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or respiratory conditions.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 to under 12 years, the appropriate dosage is 1 teaspoonful (5 mL) every 4 hours, with a maximum of 6 doses in a 24-hour period.

For children under 6 years of age, it is advised to consult a physician before administration.

It is essential to measure the dosage using the dosing cup provided with the product to ensure accuracy. The dosing cup should be kept with the product at all times to facilitate proper measurement.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, the use of this product is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm whether a patient’s current prescription includes an MAOI by consulting with the patient or reviewing their medication history.

If a patient experiences a cough that persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, it is imperative to discontinue use and seek medical advice. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication.

Patients are advised to stop using the product 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.

Additionally, individuals should seek medical advice before using this product if they have a cough that produces excessive phlegm (mucus) or if they experience a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

Dextromethorphan is contraindicated for use in conjunction with monoamine oxidase inhibitors (MAOIs) due to the potential for serious interactions. It is advised to avoid the use of dextromethorphan during MAOI therapy and for a period of 2 weeks following the discontinuation of MAOIs to mitigate the risk of adverse effects.

No additional drug interactions or drug and laboratory test interactions have been identified.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1 teaspoonful (5 mL) of the medication. For children under 6 years of age, it is advised to consult a doctor before use.

In cases of overdose, it is crucial to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately.

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. 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 mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. Specific antidotes or treatments may be required based on the substance involved, and healthcare providers should refer to established protocols for the management of overdose cases.

In summary, immediate medical intervention is critical in cases of overdose, and healthcare professionals should be prepared to implement appropriate management strategies based on the clinical presentation and substance involved.

Nonclinical Toxicology

No teratogenic effects were reported in nonclinical studies. Animal studies did not demonstrate any adverse developmental outcomes, and no increase in fetal malformations was observed. Specifically, dextromethorphan did not produce teratogenic effects in rats and rabbits. Additionally, guaifenesin was not associated with any significant adverse effects in animal studies. Overall, the data indicate a lack of teratogenic and non-teratogenic effects in the evaluated animal models. No specific nonclinical toxicology data were provided.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. The following events have been documented: dizziness, nausea, vomiting, rash, and allergic reactions, including anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, increased heart rate, and elevated blood pressure have also been reported. These reactions were observed during the postmarketing surveillance of the product.

Patient Counseling

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

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and seek medical advice 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 condition.

Additionally, patients should be advised to consult a doctor before using this medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in packaging that should be retained for future reference on full labeling. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Refrigeration is not recommended, as the product should not be stored in cold conditions. Proper handling and storage are crucial to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours. Patients should not exceed 6 doses within a 24-hour period to ensure safety and efficacy. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)