Mucus Relief Severe Congestion and Cough

Description

Dextromethorphan HBr is a cough suppressant indicated for the relief of cough. It is formulated in combination with guaifenesin, an expectorant that aids in the alleviation of chest congestion and mucus. Additionally, the formulation includes phenylephrine HCl, which is utilized to relieve nasal congestion associated with a stuffy nose. This product is intended for use in individuals aged 12 years and older.

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 relieves the intensity of coughing and the impulse to cough, which may aid in promoting sleep. It also alleviates nasal congestion associated with colds.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to measure the medication exclusively with the dosing cup provided, and to refrain from using this cup with any other products to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. It is imperative that patients do not exceed the specified dosage.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

• In children under 12 years of age.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. 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.

Healthcare professionals should exercise caution and recommend that patients consult a physician before using this product if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also seek medical advice prior to use.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) 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 seven days or are accompanied by fever, or if a cough recurs or presents 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 the medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients should 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, it is advised to seek medical advice. A return of cough, particularly if it occurs with fever, rash, or a persistent headache, may indicate a serious underlying condition and should be evaluated by a healthcare provider.

Before initiating treatment, patients with certain pre-existing conditions should consult their healthcare provider. These conditions include heart disease, thyroid disease, diabetes, high blood pressure, and difficulty urinating due to an enlarged prostate gland. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those experiencing a cough with excessive phlegm, should also 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 take this product while on MAOIs or for a period 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 confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use is contraindicated for children in this age group.

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 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

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide comprehensive care, which may include supportive measures and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is essential to address any complications that may arise during the management of an overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These reactions may occur with the use of this product.

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

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Healthcare providers should encourage patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within 7 days or if they experience symptoms accompanied by fever. Patients should also be informed to stop use and contact a doctor if their cough returns or occurs with fever, rash, or a persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Lastly, patients should be advised to consult a healthcare professional if they have a cough that produces 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 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

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 of age. Clinicians should advise patients to consult a health 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.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.

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