Guaifenesin/Dextromethorphan hydrobromide

Description

NDC 58602-825-06 identifies this product as Maximum Strength Mucus Relief DM, manufactured by Primary Health. Each extended-release tablet contains 60 mg of Dextromethorphan HBr, a cough suppressant, and 1200 mg of Guaifenesin, an expectorant. The formulation is designed to relieve cough and chest congestion by controlling cough and thinning and loosening mucus. The product is available in a package containing 42 tablets, with a dosing regimen that provides relief for up to 12 hours.

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 assists 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 aid in promoting sleep.

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

Dosage and Administration

The extended-release tablet should be taken with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken, as this may affect the release mechanism of the medication.

For adults and children aged 12 years and older, the recommended dosage is one extended-release tablet every 12 hours. The total daily dosage should not exceed two extended-release tablets within a 24-hour period. This medication can be administered without regard to the timing of meals.

Use of this product is not recommended for children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage.

Warnings and Precautions

Patients should not use this product in individuals under 12 years of age. The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

In the event of an overdose, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

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

This product is contraindicated for use in children under 12 years of age. Additionally, it should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications, which are often prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a doctor or pharmacist prior to use.

Before using this product, patients should seek medical advice 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).

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not initiate therapy with this medication while currently on an MAOI or within 2 weeks of discontinuing an MAOI.

Monitoring for adverse effects is advised if there is a potential overlap in treatment timelines, as the interaction may lead to serious clinical consequences.

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 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. Caution is advised when prescribing to younger populations, as safety and efficacy have not been established in children under 12.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 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

There is currently no specific information available regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL).

In the absence of detailed overdosage data, healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise following the administration of the medication.

In the event of suspected overdosage, it is recommended that healthcare providers implement standard supportive measures. This may include symptomatic treatment and monitoring of vital signs.

Healthcare professionals should also consider consulting a poison control center or a medical toxicologist for guidance on the management of potential overdosage cases.

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. Healthcare professionals and patients 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 they should discontinue use and consult a doctor if their cough persists for more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should be instructed to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical guidance 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° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

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 counsel patients to consult a healthcare professional if they are pregnant or breastfeeding. Additionally, 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.

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)