Cough and Chest Congestion Maximum Strength

Description

Genexa® is a maximum strength formulation designed for the relief of cough and chest congestion. This product contains dextromethorphan HBr, a cough suppressant, and guaifenesin, an expectorant, which work synergistically to alleviate symptoms associated with cough and mucus buildup. The formulation is free from artificial fillers, maintaining the same effective active ingredients while adhering to a clean medicine standard. It is flavored with organic blueberry and is available in a liquid dosage form, packaged in a 6 fl oz (177 mL) container.

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 helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, thereby aiding in sleep.

Limitations of use include the absence of any noted teratogenic or nonteratogenic effects.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before each use. The recommended dosing for adults and children aged 12 years and older is 20 mL, administered using the dosing cup provided, every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period.

For children under 12 years of age, the product is not recommended for use. The dosing cup provided should be used exclusively for this product and should not be utilized with any other products to ensure accurate measurement and safety.

Contraindications

Use of this product is contraindicated in patients 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 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings 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, this product should not be used for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

General Precautions Before using this product, individuals 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, caution is advised for those experiencing a cough accompanied by excessive phlegm (mucus).

Emergency Situations In the event of an overdose, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Discontinuation of Use Users are advised to discontinue use and consult a healthcare provider 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.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional prior to use.

Patients are instructed 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 headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Before using this product, patients should consult a healthcare provider if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a health professional before use. Additionally, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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

Packaging & NDC

Below are the non-prescription pack sizes of Cough and Chest Congestion Maximum Strength (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 20 mL in the dosing cup provided every 4 hours.

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 at 1-800-222-1222.

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 efficacy, 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. 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 currently no available data on the excretion of this drug 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. 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 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 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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve the administration of activated charcoal, intravenous fluids, or other interventions based on the clinical presentation.

It is essential for healthcare professionals to remain vigilant and prepared to address potential complications arising from an overdose, ensuring that appropriate measures are taken swiftly to mitigate risks to the patient’s health.

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 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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should counsel patients to discontinue use and seek medical advice if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Additionally, healthcare providers should encourage patients to consult with a doctor before use if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 20-25°C (68-77°F). It is essential to avoid refrigeration during storage to maintain product integrity. Proper handling practices should be observed to ensure the product remains within the specified temperature range.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Cough and Chest Congestion Maximum Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)