Maximum Strength Mucus Relief Severe Congestion and Cough

Description

No Description information provided.

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 helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, aiding in sleep. It also alleviates nasal congestion associated with colds.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is imperative that the dosing cup provided is used exclusively for measuring the medication and not for any other products.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. For children under 12 years of age, the use of this medication is not recommended.

Healthcare professionals should ensure that patients are instructed to adhere strictly to these dosing guidelines to avoid potential overdose.

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.

Furthermore, this product should not be used in excess of the directed dosage.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product.

Warnings The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General Precautions Prior to use, patients should seek medical advice if they have any of the following conditions:

• Heart disease

• High blood pressure

• Thyroid disease

• Diabetes

• Difficulty urinating due to an enlarged prostate gland

• A persistent or chronic cough, particularly associated with smoking, asthma, chronic bronchitis, or emphysema

• A cough that produces excessive phlegm (mucus)

Emergency Medical Assistance In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Discontinuation and Consultation Patients should discontinue use and consult a healthcare provider if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Symptoms that do not improve within seven days or are accompanied by fever

• A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a headache that lasts, as these may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions warrant immediate medical attention, particularly if patients experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, patients should seek medical advice. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache may indicate a serious underlying condition and should also prompt consultation with a healthcare professional.

It is important to note that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should refrain from using this product for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to consult a doctor or pharmacist prior to use.

Before using this product, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or 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 consult a healthcare provider prior to use.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination may result in serious interactions that could pose significant health risks. It is essential for healthcare providers to ensure that patients are not concurrently using MAOIs before initiating treatment with this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Mucus Relief Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin, and 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 adolescents aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as symptoms 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 procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure timely intervention and mitigate potential complications.

Healthcare providers are encouraged to familiarize themselves with the specific antidotes or treatment protocols relevant to the substance involved in the overdose, as this knowledge can significantly impact 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 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 keep the medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients that in the event of an overdose, they should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for guidance.

Additionally, healthcare providers should emphasize the importance of adhering to the recommended dosage and instruct patients not to exceed the directed amount. This will help ensure safe and effective use of the medication.

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at room temperature and must not be refrigerated to maintain its efficacy. Proper handling is essential to ensure the integrity of the product throughout its shelf life.

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 who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is crucial to keep the medication out of reach of children, and 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 Maximum Strength 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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