Broncochem

Description

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

Uses and Indications

This drug is indicated for the temporary relief of bronchial congestion and irritation of the respiratory passages, as well as nasal congestion. It serves as an antitussive and provides symptomatic relief for various allergy-related conditions, including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, and irritated, watery eyes associated with allergic rhinitis.

Limitations of Use: This drug is intended for short-term use to alleviate symptoms and is not a substitute for the management of underlying allergic conditions.

Dosage and Administration

Adults and children aged 12 years and older are advised to take one tablet every 6 hours as needed. It is imperative that the total dosage does not exceed 4 tablets within a 24-hour period. Healthcare professionals should ensure that patients are aware of this dosing limit to prevent potential overdose.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center immediately.

Warnings and Precautions

Patients should refrain from using this product unless directed by a physician if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, the presence of excessive phlegm (mucus) accompanying the cough is a contraindication for use without medical guidance.

Individuals with a history of heart disease, diabetes, or urinary difficulties due to prostate gland enlargement should also avoid this product unless specifically instructed by a healthcare provider.

In the event of experiencing nervousness, dizziness, or sleeplessness, it is advised to discontinue use and consult a physician. Should symptoms fail to improve within 7 days or if they are accompanied by fever, medical consultation is necessary.

A persistent cough may indicate a serious underlying condition. Therefore, if a cough or other symptoms persist or do not improve with any medication, or if the individual is pregnant or nursing, it is crucial to seek advice from a healthcare professional prior to using this product.

Patients currently taking another product containing pseudoephedrine HCl should not use this product unless directed by a doctor. Caution is advised when driving a motor vehicle or operating machinery while using this product.

In the case of accidental overdose, immediate professional assistance should be sought, or a poison control center should be contacted without delay.

Side Effects

Patients may experience adverse reactions that warrant attention. In particular, if symptoms such as nervousness, dizziness, or sleeplessness occur, it is advised to discontinue use and consult a healthcare professional. These reactions should be monitored closely, as they may indicate a need for medical evaluation or intervention.

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, psychiatric or emotional conditions, and Parkinson's disease. Patients should not initiate treatment with this product while on an MAOI or within 2 weeks of discontinuing an MAOI.

If there is any uncertainty regarding the presence of an MAOI in a patient's current medication regimen, it is imperative to consult a healthcare professional prior to the use of this product. This precaution is essential to avoid potential serious interactions that may arise from the combination of these agents.

Packaging & NDC

Below are the non-prescription pack sizes of Broncochem (acetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may take one tablet every 6 hours, with a maximum of 4 doses in a 24-hour period. It is essential to keep this medication out of the reach of children. In the event of an accidental overdose, professional assistance should be sought immediately, or a poison control center should be contacted.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and nursing mothers are advised to seek the counsel of a healthcare professional prior to using this product. The potential risks and benefits should be carefully considered in consultation with a qualified provider to ensure the safety of both the mother and the fetus.

Lactation

Lactating mothers should be aware that a persistent cough may indicate a serious condition. If a cough or other symptoms persist or do not improve with any medication, it is advised that they seek the advice of a healthcare professional before using this product. There is no specific data available regarding the excretion of this product in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this product during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 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 considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for guiding treatment decisions and ensuring patient safety.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek professional assistance or contact a poison control center immediately in the event of an accidental overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light to maintain its integrity. Additionally, the product must be kept out of the reach of children to ensure safety. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every six hours, with a maximum of four doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)