Dextromethorphan hydrobromide/Guaifenesin

Description

This product is available in two dosage forms: a 10 mg to 100 mg per 5 mL concentration and a 20 mg to 200 mg per 10 mL concentration. The lid label for the 10 mg-100 mg/5 mL formulation is identified by NDC 57237-312-05, while the case label is designated as NDC 57237-312-51. For the 20 mg-200 mg/10 mL formulation, the lid label is marked with NDC 57237-313-01, and the case label is NDC 57237-313-18.

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.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period.

For the formulation of 20 mg-200 mg per 10 mL, it is contraindicated for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 10 mL (1 unit dose) administered every 4 hours.

For the formulation of 10 mg-100 mg per 5 mL, it is contraindicated for use in children under 6 years of age. For children aged 6 to under 12 years, the recommended dosage is 5 mL (1 unit dose) every 4 hours. For adults and children aged 12 years and older, the recommended dosage is 10 mL (2 unit doses) every 4 hours.

Healthcare professionals should ensure that patients do not exceed the maximum dosage limit and adhere to the specified dosing intervals.

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

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and seek medical attention if their 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 the presence of a serious underlying condition that requires further evaluation.

In the event of an accidental overdose, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center without delay at 1-800-222-1222 for guidance on appropriate actions to take.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant interactions.

Common adverse reactions include the need to discontinue use if a cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical attention.

Before initiating treatment, patients should consult a healthcare provider if they have a cough that produces excessive phlegm or if they have a chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These considerations are important to ensure the safe and effective use of the medication.

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 confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 5 mL (1 unit dose) every 4 hours. In contrast, adults and children over 12 years of age may receive 10 mL (1 unit dose) every 4 hours for the 20 mg-200 mg/10 mL formulation, or 10 mL (2 unit doses) every 4 hours for the 10 mg-100 mg/5 mL formulation. Caution is advised when considering use in pediatric patients, particularly those under 12 years of age.

Geriatric Use

There is no specific information 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, given the lack of targeted clinical data in 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 associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a healthcare 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 drug insert text 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 lack of data 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 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 event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly mitigate potential risks and complications associated with overdosage. It is essential for healthcare providers to be aware of the signs and symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information.

Management of an overdose should be conducted in a clinical setting, where healthcare professionals can monitor the patient closely and implement appropriate treatment protocols based on the severity of the overdose and the patient's clinical presentation.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and rash. These events have been documented in the context of routine pharmacovigilance activities.

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 accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed that this medication should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

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

Additionally, patients should be encouraged to consult their healthcare provider before using this medication if they have a cough that occurs with 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

Care should be taken to ensure that the container remains intact; the product must not be used if the lid is torn or broken, as this may compromise the integrity of the contents. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)