Marcs Chest Congestion Relief

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 common cold. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication helps to make coughs more productive.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that children under 6 years of age consult a healthcare professional before administration.

Patients must not exceed 6 doses within a 24-hour period unless otherwise directed by a physician. Careful adherence to these guidelines is crucial to ensure safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in patients who experience symptoms accompanied by fever, rash, or persistent headache. Additionally, discontinuation and consultation with a healthcare professional are advised if cough persists for more than one week or tends to recur.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of any MAOI. If there is uncertainty regarding the presence of an MAOI in a current prescription, patients are advised to consult their healthcare provider or pharmacist prior to use.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following symptoms occur: fever, rash, or a persistent headache accompanying their symptoms. Furthermore, if a cough persists for more than one week or tends to recur, it is essential to evaluate the patient, as a persistent cough may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Center should be contacted without delay to ensure appropriate management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial to avoid using this product if a patient is on an MAOI or has stopped taking one within the past two weeks. Patients uncertain about whether their prescription contains an MAOI should consult their doctor or pharmacist prior to use.

Common adverse reactions may include symptoms that warrant immediate medical attention. Patients are advised to stop use and consult a doctor if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, it may indicate a serious underlying condition, and medical advice should be sought.

Before using this product, patients with a persistent or chronic cough—such as those associated with smoking, asthma, bronchitis, or emphysema—should consult their doctor. Furthermore, if the cough is accompanied by excessive phlegm (mucus), it is recommended that patients seek medical advice prior to use.

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 or emotional conditions, and Parkinson's disease. Patients should not use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with their healthcare provider 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 Marcs Chest Congestion Relief (dextromethorphan hydrobromide / guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 10 years may take 1/2 tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor before administration.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the 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 Center immediately.

Patients should be informed to discontinue use and consult their doctor if they experience symptoms such as fever, rash, or a persistent headache. Additionally, they should be cautioned to stop use and seek medical advice if their cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

It is important for healthcare providers to recommend that patients consult their doctor before using the medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, 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 temperature range of 15° to 30°C (59° to 86°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is important for parents or guardians to consult a doctor regarding the administration of the medication to children under 6 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Marcs Chest Congestion Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)