Quality Choice Long Acting Cough Softgel

Description

Adult cough Softgels are formulated for the relief of cough symptoms in adults. These softgels are designed to provide a convenient dosage form, facilitating ease of administration. The product is characterized by its soft gelatin shell, which encapsulates the active ingredients intended to alleviate cough.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 softgels every 6 to 8 hours as needed. It is important not to exceed a total of 8 softgels within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, it should not be administered to this age group.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in individuals 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 two weeks following the discontinuation 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 prescription medications.

Healthcare professionals should also recommend that patients seek medical advice prior to using this product if they experience a cough associated with excessive phlegm (mucus) or if they have a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, or emphysema.

Patients must be instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may signal a serious medical condition.

For pregnant or breastfeeding individuals, it is essential to seek guidance from a healthcare professional before using this product to ensure safety for both the mother and child.

General precautions include keeping this product out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be reminded to stop using the product and consult their doctor if the cough lasts beyond seven days, returns, or is accompanied by fever, rash, or persistent headache.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric, or emotional conditions, or for Parkinson’s disease. The use of this medication is contraindicated in patients currently taking MAOIs or within 2 weeks of discontinuing such treatment.

Common adverse reactions may include coughs that are chronic or associated with excessive phlegm, particularly in patients with underlying conditions such as smoking, asthma, or emphysema. Patients are advised to consult a healthcare professional before use if they experience these symptoms.

Patients should discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Additionally, pregnant or breastfeeding patients should consult a healthcare professional prior to using this medication to ensure safety for both themselves and their child.

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 verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Quality Choice Long Acting Cough Softgel (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may utilize this product; however, it is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 6 to 8 hours as needed. It is crucial for geriatric patients to adhere to the maximum dosage limit of 8 softgels within any 24-hour period.

Healthcare providers should exercise caution when prescribing this product to elderly patients, as they may be more susceptible to potential side effects or adverse reactions. Close monitoring of these patients is advised to ensure safety and efficacy. Additionally, consideration should be given to any comorbidities or concurrent medications that may necessitate dosage adjustments or increased vigilance 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 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 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and timely action are essential in managing potential overdose situations effectively.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

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. It is essential to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress that prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly mitigate potential health risks associated with overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ideally between 20°-25°C (68°-77°F). Care must be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light, heat, and moisture to ensure its integrity and efficacy. Proper handling and storage conditions are essential for maintaining the quality of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 6 to 8 hours as needed. It is advised that this medication not be used in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Quality Choice Long Acting Cough Softgel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)