Broncochem

Description

Broncochem Cold and Flu Caplets are presented in a package labeled with the code 51945-4, as per the code system 2.16.840.1.113883.6.1. The effective date for this labeling is set for March 25, 2025. The packaging includes a visual representation of the product, which is available in JPEG format, identified as "Broncochem Cold and Flu Caplets_Box-01.jpg." The product is designed for the treatment of cold and flu symptoms, although specific active ingredients and dosage information are not provided in the extracted 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 relief from allergy symptoms, including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, and irritated and watery eyes associated with allergic rhinitis.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take one tablet every 4 hours as needed. It is important not to exceed 6 doses within a 24-hour period to avoid potential adverse effects.

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, particularly if the cough is accompanied by excessive phlegm (mucus).

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 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, a healthcare professional should be consulted for further evaluation.

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

Patients should not take this product concurrently with any other medication containing pseudoephedrine HCl unless directed by a physician. 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 a range of adverse reactions associated with the use of this medication. Serious adverse reactions include nervousness, dizziness, and sleeplessness. In the event that any of these symptoms occur, it is advised that patients discontinue use and consult a healthcare professional for further guidance.

Monitoring for these reactions is essential, as they may impact the overall treatment experience and patient well-being.

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 initiate therapy with this product if they are currently taking an MAOI or have taken one within the past two weeks.

In cases where there is uncertainty regarding the presence of an MAOI in a prescription medication, it is imperative for patients to consult a healthcare professional prior to using 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 4 hours, with a maximum of 6 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are nursing should seek the advice of a health professional before using this product. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Healthcare providers should consider the individual circumstances of each patient, including any known or potential fetal impacts, when making recommendations.

Lactation

Lactating mothers are advised to seek the advice of a health professional prior to 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 its use during lactation.

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 clinical trials for 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects. The available data do not specify any further details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: nervousness, dizziness, and sleeplessness. These events were reported voluntarily or identified through surveillance programs.

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. Clinicians should counsel patients on the importance of seeking professional assistance or contacting a poison control center immediately in the event of an accidental overdose. Patients are advised to discontinue use or consult a doctor if they experience nervousness, dizziness, or sleeplessness. If symptoms do not improve within 7 days or are accompanied by fever, medical consultation is recommended. A persistent cough may indicate a serious condition; therefore, patients should seek advice from a health professional if cough or other symptoms persist or do not improve, especially if they are pregnant or nursing. Caution is advised when driving or operating machinery.

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)