Severe Congestion and Cough Max

Description

Best Choice® Max Severe Congestion & Cough is a maximum strength formulation designed to alleviate severe congestion and cough symptoms. The product is presented in a liquid dosage form, with a volume of 6 fluid ounces (177 mL). It is distributed by Value Merchandisers, Co., located at 5000 Kansas Ave, Kansas City, KS 66106. This formulation is comparable to the active ingredients found in Mucinex® FAST-MAX™ Severe Congestion & Cough. It is important to note that this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributor of Mucinex® FAST-MAX™ Severe Congestion & Cough.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically targeting cough due to minor throat and bronchial irritation and nasal congestion. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication is to be administered orally using the provided dosage cup. For adults and children aged 12 years and older, the recommended dosage is 20 mL every 4 hours. 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. Healthcare professionals should ensure that patients adhere strictly to the recommended dosage and frequency to avoid potential overdose.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the directed use may lead to adverse effects.

Warnings and Precautions

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of 2 weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a 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.

Before initiating treatment, it is essential for healthcare providers to assess the patient's medical history. Patients should be advised to seek medical guidance prior to use if they have any of the following conditions: heart disease, thyroid disease, high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also consult a healthcare professional before use.

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

Patients should be instructed to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, or if a cough recurs or is associated with fever, rash, or persistent headache, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial to discontinue use and consult a healthcare professional if any of the following symptoms arise: nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, or if a cough recurs or is associated with fever, rash, or persistent headache, medical advice should be sought, as these may indicate a serious underlying condition.

Common adverse reactions may include those related to pre-existing health conditions. Patients with heart disease, thyroid disease, high blood pressure, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider before using this medication. Furthermore, individuals experiencing chronic coughs, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

It is important to note that this medication is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI treatment within the past two weeks. Additionally, this medication is not recommended for use in children under 12 years of age.

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 disorders, emotional conditions, or 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 includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Congestion and Cough Max (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 be administered this medication. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. 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, 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.

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 needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, individuals are advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, or if a cough returns or occurs with fever, rash, or persistent headache, they should seek medical attention, as these may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage when using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15-30° C (59-86° F). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)