Maximum Strength Mucus Relief Severe Congestion and Cough

Description

No description information is available for the 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 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 guidelines to avoid potential overdose and ensure safe administration.

Contraindications

Use of this product is contraindicated in the following situations:

• Children under 12 years of age.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past 2 weeks. 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.

• Use beyond the recommended dosage is also contraindicated.

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, 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 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, high blood pressure, thyroid disease, diabetes, 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 should be contacted at 1-800-222-1222.

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 if they are accompanied by fever, or if a cough recurs or is associated with a rash or 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 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, patients are advised to seek medical advice. A return of cough, particularly if it is associated with a rash or persistent headache, may indicate a serious underlying condition and should also prompt consultation with a healthcare provider.

Before initiating treatment, patients with pre-existing conditions should consult a healthcare professional. This includes individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble 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, as well as those with coughs producing excessive phlegm, should seek medical advice prior to use.

Drug Interactions

The concurrent use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this product while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI. The combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this product. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

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 be administered this medication. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 12 years.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 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 drug. 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. 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 effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to mitigate any adverse effects associated with the 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 several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, rash, and persistent headache.

While these reactions may occur in patients using the product, they could also be indicative of a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI drug within the past two weeks. 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 advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be instructed to seek medical advice if their symptoms do not improve within 7 days or if they experience symptoms accompanied by fever. Furthermore, patients should stop using the product and contact a healthcare professional if their cough returns or is associated with a rash or persistent headache, as these may indicate a serious condition.

While 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, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. 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 doctor if they have a cough that produces excessive phlegm (mucus).

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 dose of 20 mL every 4 hours for adults and children aged 12 years and older, or as directed by a healthcare professional. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. 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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.

View product document (PDF)