Guaifenesin/Dextromethorphan hydrobromide

Description

The product is identified by NDC 49035-077-28 and is marketed under the equate™ brand, formulated to compare with Maximum Strength Mucinex® DM. Each extended-release tablet contains active ingredients of Guaifenesin 1200 mg and Dextromethorphan HBr 60 mg, classified as an expectorant and cough suppressant. This formulation is designed to control cough and facilitate the thinning and loosening of mucus. The tablets provide both immediate and extended-release effects, with a dosing interval of 12 hours. The package contains 28 extended-release tablets, each of actual size.

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 tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended that the tablet be ingested with a full glass of water. This medication can be administered without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period. The use of this product is not recommended for children under 12 years of age.

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 2 weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it should not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 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 there is uncertainty regarding the presence of an MAOI in their current medications.

Before recommending this product, healthcare providers should inquire about the patient's medical history, particularly if the patient has a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Caution is also warranted if the cough is accompanied by excessive phlegm (mucus), as these conditions may require alternative therapeutic approaches.

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 be advised to 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. These symptoms may indicate a more serious underlying condition that requires further 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 adhere to the following warnings and recommendations.

This product is contraindicated for use in children under 12 years of age. Additionally, it should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional prior to use.

Patients are instructed to stop using the product and seek medical advice 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.

Before using this product, patients should consult a healthcare provider 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).

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this medication. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy.

Healthcare professionals are advised to consult with geriatric patients prior to initiating treatment to assess individual health status and determine appropriate dosing. Close monitoring of renal function and overall response to therapy is recommended to mitigate risks and optimize therapeutic outcomes in this demographic.

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 its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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. 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 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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

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 phone number provided for this purpose.

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 immediately or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Patients should be advised 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. Furthermore, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should also recommend that patients seek medical advice before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients should be encouraged to consult a doctor if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals are advised not to use the product if the carton is open or if the printed seal on the blister is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper adherence to these storage conditions is essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours for adults and children aged 12 years and older, not exceeding two tablets within a 24-hour period. It is contraindicated for children under 12 years of age. Clinicians should advise patients not to crush, chew, or break the tablet and to take it with a full glass of water. The medication can be taken without regard to meal timing.

Drug Information (PDF)

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

View product document (PDF)