Long Acting Cough Softgels

Description

Coughgel is a pharmaceutical formulation designed for the relief of cough symptoms. It is presented in a gel dosage form, facilitating ease of administration. The product's specific composition and active ingredients are tailored to provide effective symptomatic relief. Coughgel is characterized by its clear appearance, ensuring visual consistency and quality.

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.

Limitations of Use: This medication is intended for short-term use and should not be used for persistent or chronic coughs without consulting a healthcare professional.

Dosage and Administration

Adults and children 12 years and older are advised to take 2 softgels every 6 to 8 hours, as needed, without exceeding a total of 8 softgels in any 24-hour period. This product is specifically formulated for adult use and is not intended for children under 12 years of age. For individuals under 12 years, the use of this product is contraindicated.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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 providers should exercise caution and recommend that patients seek medical advice prior to using this product if they experience a cough accompanied by excessive phlegm (mucus) or if the cough is chronic, as seen in conditions such as smoking, asthma, or emphysema.

Patients should be instructed to discontinue use and consult a healthcare professional 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 indicate a more serious underlying 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.

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

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 in the absence of noticeable signs or symptoms.

Patients should be reminded to stop using the product and consult their doctor if their cough lasts longer than 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, and it is crucial to adhere to the following warnings.

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Patients should consult a healthcare professional prior to use if they have a cough that produces excessive phlegm, or if they experience a chronic cough associated with smoking, asthma, or emphysema.

Patients are advised to 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 symptoms may indicate a serious underlying condition.

In addition, it is recommended that pregnant or breastfeeding individuals consult a healthcare professional before using this medication.

An overdose of this medication can lead to serious consequences. In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 Long Acting Cough Softgels (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 require careful consideration when using this product, as 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 important to note that prompt medical attention is critical in the event of an overdose, regardless of whether signs or symptoms are present. Healthcare providers should monitor geriatric patients closely for any adverse effects and consider potential age-related physiological changes that may affect drug metabolism and clearance. Adjustments to the dosage regimen may be necessary based on individual patient assessments and clinical judgment.

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 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

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 these patients to ensure safety and efficacy.

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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

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 seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures above 40°C (104°F). Additionally, the product must be protected from light to maintain its efficacy and stability.

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. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)