Good Neighbor Pharmacy Mucus Relief

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hypromellose, titanium dioxide, polyethylene glycol, iron oxide (red), and iron oxide (yellow).

Uses and Indications

This drug is indicated for the management of respiratory conditions characterized by excessive mucus production. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. By enhancing mucociliary function, this medication helps make coughs more productive, thereby improving respiratory function and comfort.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that parents or guardians consult a doctor for children under 6 years of age before administration.

Healthcare professionals should advise patients not to exceed 6 doses in a 24-hour period, unless otherwise directed by a physician.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms are accompanied by fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, medical advice should be sought.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before initiating treatment.

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

Patients are advised to discontinue use and consult their healthcare provider if any of the following occur: symptoms are accompanied by fever, rash, or a persistent headache; the cough persists for more than one week; or if the cough tends to recur. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Side Effects

Patients should be aware of certain warnings and recommendations regarding the use of this medication. It is advised that individuals consult their healthcare provider prior to use if they have a persistent or chronic cough, particularly if it is associated with conditions such as smoking, asthma, bronchitis, or emphysema. Additionally, patients should seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Patients are also instructed to discontinue use and consult a healthcare professional if they experience symptoms such as fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it is important to seek medical attention, as a persistent cough may indicate a serious underlying condition.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Good Neighbor Pharmacy Mucus Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 10 years may take 1/2 tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 data 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 lack of information necessitates careful clinical judgment and monitoring.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and antidotes that may be appropriate based on the clinical scenario. Continuous monitoring and supportive measures should be implemented until the patient is stabilized and further evaluation can be conducted.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for ongoing management and treatment planning.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication 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 their healthcare provider if they experience symptoms accompanied by fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, patients should be encouraged to seek medical advice. It is important to communicate that a persistent cough may indicate a serious underlying condition that requires further evaluation.

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° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent exposure to conditions outside the recommended temperature range.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours as needed, while children aged 6 to 10 years should take 1/2 tablet every 4 hours as needed. For children under 6 years of age, consultation with a doctor is recommended. It is important for patients to not exceed 6 doses within a 24-hour period unless directed by a healthcare professional.

Drug Information (PDF)

This file contains official product information for Good Neighbor Pharmacy Mucus Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)