Broncochem Tablet, Coated
FDA Label NDC 65131-111

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorio Magnachem International Srl for the product Broncochem (NDC 65131-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings, active ingredients, purpose, keep out of the reach of children, indications and usage, drug interactions, inactive ingredients, package label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

Unless directed by a physician do not take this product if persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, emphysema, or if cough is accompained by excessive phlem (mucus).  Likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician.

If nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor.

If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

A persistent cough may be a sign of a serius condition.  If cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product.

Unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne HCl, or if you are taking this product precaution must be taken when driving a motor vehicle or operating machinery.

Active Ingredients

Acetaminofen

Dextromethorphan HBr

Phenylephryne HCL

Chlorpheniramine Maleate

Purpose

Analgesic

Antihistaminic

Antitussive

Descongestant

Keep Out Of The Reach Of Children

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Indications And Usage

Bronchial congestion, irritation of the respiratory passages, nasal congestion.

Antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy rhinitis

Adults and children 12 years and over, take one tablet every 6 hours.

Do not exceed 4 doses in a 24 hour period

Drug Interactions

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI), (Certain drugs for depression, psychiatric or emotional conditions, or Parkinsons disease) or for 2 weeks after stopping that MAOI drug, if you are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product

Inactive Ingredients

Cellulose Microcrystalline, Colloidal Silicon dioxide, Green Opadry, Magnesium Stearate, Pregelatinized Starch, PEG 4000

Package Label Principal Display Panel

Image Descriptionbc&fbox (Bc Fbox)

Image Descriptionbc&fbox (Bc Fbox)

Bcflubox2 (Bcflubox2)

Bcflubox2 (Bcflubox2)

* Please review the disclaimer below.