Sunmark Chest Congestion Relief Dm

Description

The drug associated with SPL code 34089-3 does not have specific details available regarding its chemical name, physical characteristics, or inactive ingredients. Further information may be required to provide a comprehensive description of the drug's properties and formulation.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a common cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication helps to make coughs more productive.

Dosage and Administration

Adults and children 12 years of age and over 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 parents or guardians consult a doctor for children under 6 years of age before administration.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period unless directed otherwise by a physician.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should exercise caution and recommend that patients seek medical advice prior to using this product 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 consult their healthcare provider if their cough is accompanied by excessive phlegm (mucus).

Patients are instructed to discontinue use and contact their healthcare provider if they experience symptoms such as 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 that requires further evaluation.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Center immediately to ensure appropriate management and care.

Side Effects

Patients using this product should be aware of certain warnings and adverse reactions. It is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks. Patients uncertain about whether their prescription medication contains an MAOI are advised to consult their healthcare provider or pharmacist prior to using this product.

In the context of over-the-counter (OTC) use, patients should discontinue use and seek medical advice 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, warranting further evaluation.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, bronchitis, or emphysema, should consult a healthcare professional before using this product. 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, psychiatric or emotional conditions, and Parkinson's disease. Patients should not use this product while taking an MAOI or for a period 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 Sunmark Chest Congestion Relief Dm (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

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 therapeutic response, 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 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

There is no specific information 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 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and treatment protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Center immediately.

Healthcare providers should instruct patients to discontinue use and consult a doctor if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, patients should be informed to stop using the medication and seek medical advice if a cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

Patients should also be encouraged to consult their healthcare provider before using this medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Furthermore, it is important to advise patients 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 efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, while children aged 6 to 10 years should take half a tablet every four hours as needed. It is advised that children under 6 years of age consult a doctor before use. Patients should not exceed six doses within a 24-hour period unless directed by a healthcare professional.

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

Drug Information (PDF)

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

View product document (PDF)