Care One Chest Congestion Relief

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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 common cold. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication helps to make coughs more productive.

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

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 children under 6 years of age consult a doctor prior to administration.

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

Contraindications

Use is contraindicated in patients presenting with symptoms accompanied by fever, rash, or persistent headache, as these may indicate a more serious underlying condition. Additionally, the product should not be used if a cough persists for more than one week or tends to recur, as this may suggest a chronic or unresolved respiratory issue that requires further evaluation.

Warnings and Precautions

The use of this product is contraindicated in patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised that this product not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should ensure that patients are aware of this contraindication and encourage them to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice 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 may indicate a serious underlying condition, and medical evaluation is warranted.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Center should be contacted without delay. It is crucial for healthcare providers to educate patients on the importance of adhering to these warnings to ensure their safety while using this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial to avoid using this product if a patient is on an MAOI or has stopped taking one within the past two weeks. Patients uncertain about whether their prescription includes an MAOI should consult their healthcare provider or pharmacist prior to use.

Common adverse reactions may include symptoms that warrant immediate medical attention. Patients are advised to stop using the product and seek medical advice if they experience symptoms such as fever, rash, or persistent headache. Additionally, if a cough persists for more than one week or tends to recur, it may indicate a serious underlying condition, and medical consultation is recommended.

Before using this product, patients should also consult their healthcare provider if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Furthermore, if the cough is accompanied by excessive phlegm (mucus), it is advisable to seek medical advice prior to use.

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 or emotional conditions, and Parkinson's disease. Patients should not use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with their healthcare provider or pharmacist if they are uncertain whether their current prescription medication contains an MAOI before initiating treatment with this product. This precaution is critical to avoid potential adverse effects associated with the interaction.

Packaging & NDC

Below are the non-prescription pack sizes of Care One Chest Congestion Relief (dextromethorphan hydrobromide / 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 recommended to consult a doctor prior to use.

Geriatric Use

There is no specific information available 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 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

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or unusual symptoms that may arise following administration.

In the event of suspected overdosage, standard medical protocols should be followed. This includes assessing the patient's clinical status, providing supportive care, and implementing symptomatic treatment as necessary. Healthcare providers should also consider consulting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Due to the lack of detailed information on overdosage, it is imperative for healthcare professionals to remain vigilant and to document any occurrences of suspected overdosage for further evaluation and reporting.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Center in the event of an overdose. It is important for patients to stop using the medication and consult their healthcare provider if they experience symptoms such as fever, rash, or a persistent headache.

Healthcare providers should inform patients that if their cough persists for more than one week or tends to recur, they should discontinue use and consult their doctor, as a persistent cough may indicate a serious underlying condition. Additionally, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have a persistent or chronic cough associated with conditions such as smoking, asthma, bronchitis, or emphysema.

Patients should also be advised to consult their healthcare provider before using the medication if their cough is accompanied by excessive phlegm (mucus). This information is crucial for ensuring safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, while children aged 6 to 10 years should take half a tablet every four hours as needed. It is advised that children under 6 years of age consult a doctor before use. Patients should not exceed six doses within a 24-hour period unless directed by a healthcare professional.

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

Drug Information (PDF)

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

View product document (PDF)