Mucinex Fast-Max Kickstart Severe Congestion and Cough

Description

This product is identified by NDC 72854-159-66 and is formulated as a menthol-flavored liquid, available in a 6 fl oz (180 mL) dosage form. It contains dextromethorphan HBr, which serves as a cough suppressant, and guaifenesin, an expectorant that thins and loosens mucus. The formulation is designed to relieve chest congestion and control cough 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 alleviates the intensity of coughing and reduces the impulse to cough, which may aid in promoting sleep.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Administration should be performed orally using the dosing cup provided, which must not be used with any other products.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be taken every 4 hours as needed or as directed by a healthcare professional. It is contraindicated for children under 12 years of age.

Healthcare professionals should ensure that patients measure the dosage accurately using only the dosing cup included with the product.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding; consultation with a healthcare professional is advised prior to use in these populations.

Additionally, the product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Warnings and Precautions

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

Contraindications This product must not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for a minimum of two weeks following the cessation 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 current prescription medications.

Pre-existing Conditions Prior to use, patients should seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider.

Dosage Compliance Patients are advised to strictly adhere to the recommended dosage and should not exceed the directed amount while using this product.

Monitoring Symptoms Patients should discontinue use and contact a healthcare professional if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Emergency Situations In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients should refrain from using it for at least two weeks after stopping an MAOI.

Common adverse reactions may include persistent or chronic cough, especially in patients with underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should consult a healthcare professional prior to use.

Patients are advised to adhere strictly to the recommended dosage. If a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, it is imperative to discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition.

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, certain psychiatric conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing 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 Mucinex Fast-Max Kickstart Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin). 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 and adults aged 12 years and older, the recommended dosage is 20 mL administered every 4 hours, with a maximum of 6 doses in a 24-hour period. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing to this patient population, as the lack of specific guidance necessitates careful evaluation of renal function and potential impacts on drug efficacy and safety.

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

Overdosage of this product can occur if the recommended dosage is exceeded. It is imperative that healthcare professionals advise patients to adhere strictly to the prescribed dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is essential to monitor the patient for potential symptoms, which may vary depending on the specific characteristics of the product. Symptoms of overdosage can include, but are not limited to, increased severity of side effects or adverse reactions.

Management of overdosage should involve immediate medical evaluation. Healthcare professionals are encouraged to implement supportive care measures and consider symptomatic treatment as necessary. If the overdosage is severe, further interventions may be required, including the possibility of contacting a poison control center for specialized guidance.

In summary, adherence to the recommended dosage is crucial to prevent overdosage, and prompt medical attention is advised in cases of suspected excessive intake.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nausea, vomiting, dizziness, and allergic reactions, which include rash, itching, and swelling.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important to emphasize the necessity of this consultation to ensure the safety of both the patient and the child.

Providers should also instruct patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. This precaution is vital for safeguarding the health of young children.

In the event of an overdose, healthcare providers must inform patients to seek medical help immediately or contact a Poison Control Center. Prompt action is crucial in managing potential overdose situations effectively.

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 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure optimal efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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