Broncochem Granule, For Solution
FDA Label NDC 65131-097

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 65131-097). 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, dosage and administration, inactive ingredients, bag image, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Warnings

Liver warning:

This product contains acetaminophen, severe liver damage may occur if you take:

  • More than 6 packets in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.
  • three (3) or more alcoholic drinks every day while using this product.

    • Sore Tthroat warning: 

    If sore throat is severe, persists for more than 2 days, is accompainied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly.

Active Ingredients

Acetaminophen.

Phenylephrine Hydrochloride.

Chlorpheniramine Maleate

Purpose

Pain reliever/fever reducer

Nasal decongestant

Antihistamine

Keep Out Of The Reach Of Children

In case of overdose get medical help or contact a Poison Control Center right away, prompt medical attention is critical for adults as well as for children even if you do not notice any signs symptoms.

Indications And Usage

Temporarily relieves these symptoms due to a cold:

  • Minor aches and pains.
  • Minor sore throat pain.
  • Headache.
  • Nasal and sinus congestion.
  • Runny nose.
  • Sneezing
  • Itchy nose or throat.
  • Itchy, watery eyes due to hay fever.
  • Cough due to minor throat and bronchial irritation.
  • Temporarily reduces fever.

Dosage And Administration

Do not use more than directed.

Take every 4 hours; do not take more than 6 packets in 24 hours unless directed by a doctor.

Children under 4 years of age-Do not ue.

Children from 4 to 12 years of age-Do not use unless directed by a doctor.

Adults and children 12 years of age and over-One packet

Dissolve contents of one packet into 8 oz of hot or cold water, consume entire drink within 10-15 minutes.

If using a microwave, add contents of one packet to 8 oz of cool wter stir briskly before and after heating.

Do not over heat.

Inactive Ingredients

Ascorbic acid, Silicon Dioxide, Citric Acid Monohydrate, Ethyl alcohol, Lime flavor, Maltodextrin, Sucrose, Honey, Sucralose, Tricalcium phosphate, Propyl gallate, Yellow No.5

Box Image

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Bcfteabox25.jpg (Bcfteabox25)

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