Cvs Health Cough Suppressant Softgel

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 drug.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 softgels every 6 to 8 hours as needed. The maximum dosage should not exceed 8 softgels within a 24-hour period.

This medication is not recommended for use in children under 12 years of age.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 accompanied by excessive phlegm (mucus) or if they have a chronic cough associated with 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 indicate a serious underlying condition.

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

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

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. 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 contact their doctor if their cough lasts for more 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, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, and patients should refrain from using it for at least two weeks after stopping an MAOI.

Common adverse reactions may include cough that is accompanied by excessive phlegm or that persists for an extended period, particularly in individuals with underlying conditions such as smoking, asthma, or emphysema. Patients are advised to consult a healthcare professional before using this medication if they experience these symptoms.

Patients should discontinue use and seek medical advice if their cough lasts longer 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.

In the event of an overdose, it is crucial 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 of overdose are initially apparent.

For pregnant or breastfeeding patients, it is recommended to consult a healthcare professional prior to use to ensure safety for both the mother and 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 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 Cvs Health Cough Suppressant 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, including geriatric patients aged 65 and older, the recommended dosage is 2 softgels every 6 to 8 hours as needed.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may be more susceptible to adverse effects. It is essential to monitor these patients closely for any signs of overdose, as prompt medical attention is critical regardless of the presence of symptoms. Adjustments to the dosage may be necessary based on individual patient response and tolerance.

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 maternal health. 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 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 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 packaging that ensures its integrity and efficacy. It should be stored at room temperature, specifically between 20°-25°C (68°-77°F). It is essential to protect the product from light, heat, and moisture to maintain its quality and effectiveness. Proper handling and storage conditions are crucial for preserving the product's stability.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 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, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Cvs Health Cough Suppressant Softgel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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