Mucus Relief Severe Congestion and Cough

Description

+TopCare® is a maximum strength formulation indicated for mucus relief, severe congestion, and cough. The product contains the following active ingredients: Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. It provides multi-symptom relief by controlling cough, relieving nasal and chest congestion, and thinning and loosening mucus.

The product is suitable for individuals aged 12 and older and is available in a 6 FL OZ (177 mL) volume. It is flavored with mixed berry. The product is distributed by Topco Associates LLC, located in Itasca, IL 60143. A tamper evident warning is included, stating that the product should not be used if the imprinted safety seal under the cap is broken or missing.

This product is not manufactured or distributed by RB Health (US) LLC, the owner of the registered trademark Mucinex® FAST-MAX® Severe Congestion & Cough. For inquiries, contact 1-888-423-0139 or email topcare@topco.com. Further information can be found at www.topcarebrand.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 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. It also provides relief from nasal congestion associated with colds.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed the directed amount, and patients must not take more than six doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered using the dosing cup provided, every 4 hours as needed. It is imperative that only the dosing cup included with the product is utilized for accurate measurement.

Children under 12 years of age should not use this medication.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson’s disease, and 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.

Additionally, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

Patients should not use this product if they are 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 two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should exercise caution and advise patients to seek medical consultation before use if they have any of the following conditions: difficulty urinating due to prostate gland enlargement, thyroid disease, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), high blood pressure, heart disease, diabetes, or a cough that produces excessive phlegm (mucus).

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is associated with fever, 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 persistent cough lasting more than one week, particularly if it tends to recur or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and should be evaluated by a healthcare provider.

Common adverse reactions may also arise, particularly in patients with pre-existing conditions. It is recommended that individuals consult a doctor prior to use if they have difficulty urinating due to prostate gland enlargement, thyroid disease, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with high blood pressure, heart disease, diabetes, or those experiencing a cough with excessive phlegm (mucus) should also seek medical advice before using this medication.

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 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 Mucus Relief Severe Congestion and Cough (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 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

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.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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. 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose 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 of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to emphasize that patients must not exceed the recommended dosage.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed to seek medical advice if their symptoms do not improve within 7 days, or if they occur alongside a fever. Patients should also be made aware that a cough persisting for more than one week, recurring coughs, or coughs accompanied by fever, rash, or persistent headache may indicate a serious condition and warrant medical evaluation.

Before initiating treatment, healthcare providers should encourage patients to discuss their medical history, particularly if they have difficulty urinating due to an enlarged prostate gland, thyroid disease, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients with high blood pressure, heart disease, diabetes, or a cough that produces excessive phlegm (mucus) should also consult their healthcare provider prior to use.

Storage and Handling

The product is supplied with an expiration date indicated on the package. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, it is crucial to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

Parents are encouraged to educate themselves about the potential for medicine abuse among teenagers by visiting www.StopMedicineAbuse.org. No further information is available regarding laboratory tests 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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