Mucus Relief Severe Congestion and Cough

Description

Dextromethorphan HBr serves as a cough suppressant, while guaifenesin functions as an expectorant. Phenylephrine HCl is included as a nasal decongestant. This formulation is designed for maximum strength efficacy. The product features a tamper-evident safety seal; it should not be used if the printed safety seal around or under the cap is broken or missing. It is distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015, and additional information can be found at walgreens.com.

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.

Limitations of use include its application solely for symptomatic relief and not as a treatment for underlying conditions.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period.

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

Prior to administration, the solution must be shaken well. The dosing cup should be kept with the device and should only be used for measuring the medication, as other dosing devices may lead to inaccurate dosing.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. This is due to the potential for serious interactions that may occur with MAOIs, which 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, this product is contraindicated in children under 12 years of age. Use in this population has not been established and may pose safety concerns.

Furthermore, 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 individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. It is also advised not to use this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

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

Healthcare professionals should exercise caution and advise patients to consult a physician prior to use 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. Additionally, patients experiencing a cough that produces excessive phlegm (mucus) should seek medical advice before using this product.

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 should be instructed to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough recurs or presents with fever, rash, or persistent headache, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, it is advised to seek medical attention. A return of cough, particularly if it occurs with fever, rash, or a persistent headache, may indicate a serious underlying condition and warrants immediate evaluation by a healthcare provider.

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 minimum 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 verify whether their current prescription medication contains 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 use this medication. For patients aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided. Caution is advised when considering the use of this medication in pediatric populations, as safety and efficacy have not been established in children under the age of 12.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential age-related physiological changes. Monitoring for efficacy and safety is advised, as with any medication prescribed to 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 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 the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous monitoring of vital signs and clinical status is recommended to ensure patient safety and to address any complications that may arise during the management of an overdose.

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 identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 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 be instructed to refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription contains an MAOI, they should be encouraged to consult their doctor or pharmacist.

Providers should emphasize that this product is not intended for use in children under 12 years of age. Patients should be informed to discontinue use and consult a doctor 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 seven days or if they occur alongside a fever.

Patients should also be cautioned to stop use and consult a doctor if their cough returns or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition. It is important to remind patients to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should encourage patients to consult a doctor 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. Patients should also be advised to seek medical advice 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 storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. 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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