Mucus Relief Severe Congestion and Cough

Description

No description information is available for the specified drug.

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 clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may help patients achieve restful sleep. It also alleviates nasal congestion associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the directed amount, and no more than 6 doses should be taken within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered using the dosing cup provided, every 4 hours as needed. It is essential to utilize only the dosing cup included with the product to ensure accurate measurement.

This medication is not indicated for use in children under 12 years of age.

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 uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

The use of this product is contraindicated in 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 with a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

General precautions should be taken prior to use. Patients should seek medical advice if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, thyroid disease, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), high blood pressure, heart disease, diabetes, or a cough accompanied by excessive phlegm (mucus).

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, further evaluation is necessary. A persistent cough lasting more than one week, particularly if it tends to recur or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and should be assessed by a healthcare provider.

Before initiating treatment, patients should inform their healthcare provider if they have any of the following conditions: difficulty in urination due to prostate gland enlargement, thyroid disease, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), high blood pressure, heart disease, diabetes, or a cough that produces excessive phlegm (mucus). These pre-existing conditions may influence the safety and efficacy of the medication.

Drug Interactions

The concurrent use of dextromethorphan with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take dextromethorphan while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. This combination can result in serious interactions that may pose significant health risks.

No additional drug interactions or drug and laboratory test interactions have been identified. Therefore, monitoring for interactions is not necessary beyond the specified contraindication with MAOIs.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Severe Congestion and Cough (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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 20 mL administered every 4 hours using the dosing cup provided.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is essential for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

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

Postmarketing experience has revealed reports of various adverse reactions associated with the use of the product. These include nervousness, dizziness, and sleeplessness. Additionally, allergic reactions such as rash, itching, and swelling have been documented. Gastrointestinal disturbances, including nausea and vomiting, were also reported. Cardiovascular events, notably elevated blood pressure and palpitations, have been observed, along with respiratory issues such as difficulty breathing. It is important to note that these reactions were reported in patients using the product and may not be directly related to the drug.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if their symptoms do not improve within seven days, or if they experience a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, healthcare providers should recommend that patients consult a doctor prior to use if they have any of the following conditions: difficulty urinating due to an enlarged prostate gland, thyroid disease, a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, high blood pressure, heart disease, diabetes, or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied with an expiration date clearly indicated on the package. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions from this temperature are permissible, provided they remain within the range of 15°C to 30°C (59°F to 86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No additional information is available regarding laboratory tests or postmarketing experience.

Clinicians should be aware that the medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for children under 12 years. Patients who are pregnant or breastfeeding are advised to consult a healthcare professional prior to use. Additionally, resources are available for understanding the risks of medicine abuse among teens at www.StopMedicineAbuse.org.

Drug Information (PDF)

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

View product document (PDF)